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									                                                                                                                                                                                          58993

                                        Rules and Regulations                                                                                           Federal Register
                                                                                                                                                        Vol. 72, No. 201

                                                                                                                                                        Thursday, October 18, 2007



                                        This section of the FEDERAL REGISTER                    long.113°30′00″ W.’’ This action corrects               DEPARTMENT OF HEALTH AND
                                        contains regulatory documents having general            that error.                                             HUMAN SERVICES
                                        applicability and legal effect, most of which
                                        are keyed to and codified in the Code of                Correction to Final Rule                                Food and Drug Administration
                                        Federal Regulations, which is published under
                                        50 titles pursuant to 44 U.S.C. 1510.                   ■ Accordingly, pursuant to the authority                21 CFR Part 314
                                                                                                delegated to me, the legal description as
                                        The Code of Federal Regulations is sold by                                                                      [Docket No. 2000N–1545] (formerly 00N–
                                                                                                published in the Federal Register on
                                        the Superintendent of Documents. Prices of                                                                      1545)
                                        new books are listed in the first FEDERAL               August 10, 2007 (72 FR 44955),
                                        REGISTER issue of each week.                            Airspace Docket No. 06–ANM–12, FAA                      Applications for Food and Drug
                                                                                                Docket No. FAA–2006–26364, and                          Administration Application Approval to
                                                                                                incorporated by reference in 14 CFR                     Market a New Drug; Revision of
                                        DEPARTMENT OF TRANSPORTATION                            71.1, is corrected as follows:                          Postmarketing Reporting
                                                                                                                                                        Requirements
                                        Federal Aviation Administration                         § 71.1       [Amended]
                                                                                                ■ On page 44956, correct the legal                      AGENCY:    Food and Drug Administration, 

                                        14 CFR Part 71                                                                                                  HHS. 

                                                                                                description for Beaver, UT, to read as
                                        [Docket FAA No. FAA–2006–26364;                         follows:                                                ACTION:   Final rule. 

                                        Airspace Docket No. 06–ANM–12]
                                                                                                  Paragraph 6005—Class E airspace areas                 SUMMARY: The Food and Drug
                                        Establishment of Class E Airspace;                      extending upward from 700 feet or more                  Administration (FDA) is amending its
                                        Beaver, UT                                              above the surface of the earth.                         regulations describing postmarketing
                                                                                                *        *      *       *      *                        reporting requirements to implement
                                        AGENCY:  Federal Aviation                                                                                       certain provisions of the Food and Drug
                                        Administration (FAA), DOT.                              ANM UT E5           Beaver, UT [Corrected]              Administration Modernization Act of
                                        ACTION: Final rule; correction.                           Beaver Municipal Airport, UT (lat.                    1997 (the Modernization Act). The
                                        SUMMARY: This action corrects a final
                                                                                                38°13′51″ N., long. 112°40′31″ W.)                      changes apply to drug products that are
                                        rule published in the Federal Register
                                                                                                  Bryce Canyon VORTAC (lat. 37°41′21″ N.,               life supporting, life sustaining, or
                                        August 10, 2007 (72 FR 44955),
                                                                                                long. 112°18′14″ W.)                                    intended for use in the prevention of a
                                                                                                  That airspace extending upward from 700               serious disease or condition and that
                                        Airspace Docket No. 06–ANM–12, FAA
                                                                                                feet above the surface within a 5.0-mile                were not originally derived from human
                                        Docket No. FAA–2006–26364. In that
                                                                                                radius of Beaver Municipal Airport and                  tissue and replaced by a recombinant
                                        rule, an error was made in the legal
                                                                                                within 3 miles each side of the 261° bearing            product. The final rule implements
                                        description for Beaver, UT. Specifically,
                                                                                                from the Airport extending from the 5.0-mile            provisions of the Modernization Act by
                                        the longitude referencing V–293 stated
                                                                                                radius to 14.0 miles west of the Airport, and           requiring an applicant who is the sole
                                        ‘‘* * * long. 133°00′00″ W.’’ instead of                that airspace extending upward from 1,200
                                        ‘‘* * * long.113°30′00″ W.’’ This action                                                                        manufacturer of one of these products to
                                                                                                feet above the surface beginning at lat.                notify FDA at least 6 months before
                                        corrects that error.                                    38°19′24″ N., long. 113°30′00″ W.; thence east          discontinuing manufacture of the drug
                                        DATES: Effective Date: 0901 UTC,                        on V–244 to lat. 38°22′22″ N., long.                    product.
                                        October 25, 2007. The Director of the                   112°37′47″ W.; thence south on V–257 to
                                        Federal Register approves this                          BRYCE CANYON VORTAC; thence west on                     DATES: This rule is effective December
                                        incorporation by reference action under                 V–293 to lat. 37°56′30″ N., long. 113°30′00″            17, 2007.
                                        1 CFR part 51, subject to the annual                    W.; to point of beginning.                              FOR FURTHER INFORMATION CONTACT:
                                        revision of FAA Order 7400.9 and                                                                                  S. Mitchell Weitzman, Center for Drug
                                                                                                *        *      *       *      *
                                        publication of conforming amendments.                                                                                Evaluation and Research (HFD–7),
                                        FOR FURTHER INFORMATION CONTACT:                           Issued in Seattle, Washington, on October                 Food and Drug Administration,
                                        Eldon Taylor, Federal Aviation                          5, 2007.                                                     5600 Fishers Lane, Rockville, MD
                                        Administration, System Support Group,                   Clark Desing,                                                20857, 301–443–5535, or
                                        Western Service Area, 1601 Lind                         Manager, System Support Group, Western                    Stephen Ripley, Center for Biologics
                                        Avenue, SW., Renton, WA 98057;                          Service Center.                                              Evaluation and Research (HFM–17),
                                        telephone (425) 917–6726.                               [FR Doc. E7–20389 Filed 10–17–07; 8:45 am]                   Food and Drug Administration,
                                        SUPPLEMENTARY INFORMATION:                              BILLING CODE 4910–13–P
                                                                                                                                                             1401 Rockville Pike, Rockville, MD
                                                                                                                                                             20852–1448, 301–827–6210.
                                        History
                                                                                                                                                        SUPPLEMENTARY INFORMATION:
                                          On August 10, 2007, a final rule for
                                        Airspace Docket No. 06–ANM–12, FAA                                                                              I. Background
                                        Docket No. FAA–2006–26364 was                                                                                      In the Federal Register of November
                                        published in the Federal Register (72                                                                           7, 2000 (65 FR 66665), we (FDA) issued
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                                        FR 44955), establishing Class E airspace                                                                        a proposed rule to revise our
                                        in Beaver, UT. The longitude                                                                                    postmarketing reporting requirements to
                                        referencing V–293 was incorrect in that                                                                         implement section 506C of the Federal
                                        the longitude stated ‘‘* * * long.                                                                              Food, Drug, and Cosmetic Act (the act)
                                        133°00′00″ W.’’ instead of ‘‘* * *                                                                              (21 U.S.C. 356c). Section 506C of the act


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                                        58994            Federal Register / Vol. 72, No. 201 / Thursday, October 18, 2007 / Rules and Regulations

                                        requires manufacturers who are the sole                 whether regulated by CDER or CBER, to                 B. Reduction in the Discontinuance
                                        manufacturers of certain drug products                  the following designated offices:                     Notification Period
                                        to notify us at least 6 months before                     (1) The Drug Shortage Coordinator at
                                                                                                                                                         Under section 506C(b) of the act, we
                                        discontinuing manufacture of the                        the address of Director of CDER;
                                                                                                                                                      may reduce the 6-month notification
                                        products. Section 506C(a) applies to                      (2) The Drug Registration and Listing
                                                                                                                                                      period if the manufacturer certifies that
                                        sole manufacturers of products that                     Team, Division of Compliance Risk
                                                                                                                                                      good cause exists for the reduction. We
                                        meet the following three criteria:                      Management in CDER; and
                                                                                                  (3) The director in the review division             are adding § 314.91 to implement
                                           (1) The products are life supporting,
                                                                                                in CDER or CBER that is responsible for               section 506C(b) of the act. Section
                                        life sustaining, or intended for use in
                                                                                                reviewing the application.                            314.91 allows for a reduction in the 6-
                                        the prevention of a debilitating disease
                                        or condition;                                             The final rule eliminates the proposed              month discontinuance notification
                                           (2) The products must have been                      requirement to notify the Director of                 period, as required under
                                        approved under section 505(b) or (j) of                 CBER.                                                 § 314.81(b)(3)(iii)(a), when we find good
                                        the act (21 U.S.C. 355(b) or (j)); and                    We have also revised the proposed                   cause exists for the reduction. We may
                                           (3) The products are not originally                  rule to change the manner in which the                find good cause exists based on
                                        derived from human tissue and replaced                  agency publicly discloses a list of all               information certified by an applicant in
                                        by a recombinant product.                               drug products to be discontinued under                a written request for a reduction of the
                                           Under section 506C of the act, we may                § 314.81(b)(3)(iii)(a), as described in               discontinuance notification period. In
                                        reduce the 6-month notification period                  paragraph (b)(3)(iii)(c) of § 314.81. In the          limited circumstances, we may find
                                        if good cause exists for the reduction,                 preamble to the proposed rule, we                     good cause exists based on information
                                        and we must provide information to the                  stated that we would provide                          already known to us (e.g., withdrawal of
                                        public about the product                                discontinuance information both on the                the drug from the market based upon
                                        discontinuance.                                         Internet and in notices in the Federal                formal regulatory action or resulting
                                                                                                Register. Since the proposed rule was                 from consultations between the
                                        II. Overview of the Final Rule Including                                                                      applicant and us).
                                        Changes to the Proposed Rule                            published in November 2000, access to
                                                                                                the Internet has dramatically increased.                 To assist a manufacturer that is
                                           This final rule amends the                           As a result, we believe that posting on               requesting a reduction in the
                                        postmarketing provisions of FDA                         the Internet is an effective means to                 notification period, § 314.91(c)(1)
                                        regulations in § 314.81 (21 CFR 314.81)                 distribute the discontinuance                         provides a template for certification that
                                        to require applicants who are sole                      information to appropriate physician                  good cause exists. The following
                                        manufacturers of certain drug products                  and patient organizations, as required                circumstances can establish good cause
                                        to notify us at least 6 months before                   by section 506C(c) of the act, and to the             for a reduction in the discontinuance
                                        discontinuing manufacture of the                        public. Therefore, we no longer plan to               notification period:
                                        products. The 6-month notification                      publish the discontinuance information                   • A public health problem may result
                                        period required by these regulations                    in the Federal Register. This                         from continuation of manufacturing for
                                        will give certain individuals who are                   information will be distributed through               the 6-month period;
                                        currently taking affected medications                   posting on the Internet (www.fda.gov/                    • A biomaterials shortage prevents
                                        that will be discontinued an                            cder/drug/shortages/default.htm).                     the continuation of the manufacturing
                                        opportunity to evaluate alternative                                                                           for the 6-month period;
                                        therapeutic options, and will provide                   A. Notification Requirements                             • A liability problem may exist for
                                        additional time for FDA to evaluate                        As described in section I of this                  the manufacturer if the manufacturing is
                                        replacement products when available.                    document, we are amending our                         continued for the 6-month period;
                                        Under § 314.91 (21 CFR 314.91), we may                  postmarketing reporting requirements                     • Continuation of manufacturing for
                                        reduce the 6-month notification period                  in§ 314.81 to implement new statutory                 the 6-month period may cause
                                        when we find good cause exists for the                  requirements under section 506C of the                substantial economic hardship for the
                                        reduction.                                              act. Section 314.81(b)(3)(iii) requires an            manufacturer;
                                           In this rulemaking, the agency                       applicant who is the sole manufacturer                   • The manufacturer has filed for
                                        finalizes all of the substantive                        of an approved drug product to notify us              bankruptcy under chapter 7 or 11 of title
                                        provisions in the proposed rule. In                     in writing at least 6 months before                   11, United States Code (11 U.S.C. 701 et
                                        addition, we have made some revisions,                  discontinuing manufacture of the drug                 seq. and 1101 et seq.); or
                                        none of which changed the substantive                   product if the drug product meets the                    • The manufacturer can stop making
                                        requirements. One revision reflects a                   following criteria:                                   the product but still distribute it to
                                        relatively minor change in                                 (1) The product is life supporting, life           satisfy existing market need for 6
                                        administrative process. In that instance,               sustaining, or intended for use in the                months.
                                        for administrative efficiency, we have                  prevention of a serious disease or                       • Other good cause exists for the
                                        revised proposed §§ 314.81(b)(3)(iii)(b)                condition; and                                        reduction.
                                        and 314.91(c)(3) to make the notification                  (2) The product was not originally
                                        procedures for manufacturers planning                                                                         C. Disclosure of Discontinuance
                                                                                                derived from human tissue and replaced
                                        to submit a notice of discontinuance (or                                                                      Information to the Public
                                                                                                by a recombinant product.
                                        a request for reduction in the                             A life supporting or life sustaining                  Section 506C(c) of the act states that,
                                        discontinuance notification period) the                 drug is a drug product that is essential              to the maximum extent practicable, we
                                        same for drugs regulated by the Center                  to, or that yields information that is                are to distribute information to
                                        for Drug Evaluation and Research                        essential to, the restoration or                      appropriate physician and patient
                                        (CDER) or the Center for Biologics                      continuation of a bodily function                     organizations about the discontinuation
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                                        Evaluation and Research (CBER). As                      important to the continuation of human                of products described in section
                                        revised, manufacturers are to send                      life. The phrase ‘‘debilitating disease or            506C(a). To implement section 506C(c)
                                        notifications of discontinuance or                      condition,’’ as stated in section 506C(a)             of the act, we will, in accordance with
                                        requests for reduction in notification                  of the act, means serious disease or                  § 314.81(b)(3)(iii)(c), publicly disclose a
                                        periods for all drugs subject to this rule,             condition.                                            list of all drug products to be


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                                                         Federal Register / Vol. 72, No. 201 / Thursday, October 18, 2007 / Rules and Regulations                                       58995

                                        discontinued under paragraph                            products to license the products to other             suggestion could also create potential
                                        (b)(3)(iii)(a) of § 314.81. If the                      pharmaceutical firms.                                 confusion because some drugs are
                                        notification period is reduced under                       We agree that it could be in the                   approved but not marketed, and are
                                        § 314.91, we will state the reason(s) for               interest of public health for                         therefore placed in the ‘‘discontinued’’
                                        the reduction and the anticipated date                  manufacturers of products covered by                  section of the Orange Book. Finally, we
                                        that manufacturing will cease. As                       this final rule to find alternative means             note that there are other generally
                                        described in the preamble to the                        of making these products available to                 reliable sources for obtaining
                                        proposed rule (65 FR 66665 at 66667),                   patients, including the possibility of                commercial manufacturing information
                                        the listing of discontinued products will               transferring the new drug application                 that can adequately provide information
                                        include the following information:                      (NDA) or abbreviated new drug                         on sole manufacturers, rendering the
                                          • The brand and generic name, the                     application (ANDA) for these products                 comment’s suggestion unduly
                                        manufacturer, and indication(s) of the                  to other manufacturers. However, the                  restrictive.
                                        drug product;                                           act does not require an applicant                        (Comment 4) One comment requested
                                          • Whether a reduction in the                          covered by this rule to transfer an NDA               that we clarify the phrase
                                        notification period was granted by the                  or ANDA, or use any other means to                    ‘‘discontinuing manufacture.’’ The
                                        agency under § 314.91;                                  ensure product availability. The act                  comment indicated that discontinuance
                                          • The reason(s) for a notification                    merely requires applicants to meet the                and the 6-month notification period
                                        period of less than 6 months, if                        notice requirements implemented by                    should apply when a manufacturer is
                                        applicable; and                                         this rule. Therefore, while we agree that             ceasing production of a product with
                                                                                                it would be preferable for manufacturers              the intent of withdrawing the product
                                          • Any additional information the
                                                                                                to find alternative ways to make these                from the market, not when there is a
                                        agency may have regarding anticipated
                                                                                                products available to patients, this                  temporary cessation of manufacturing
                                        product availability.
                                                                                                regulation will not require such                      resulting, for example, from technical
                                          We will post the discontinuance
                                                                                                measures.                                             production difficulties.
                                        information on the Internet at                                                                                   We agree with the comment that the
                                        www.fda.gov/cder/drug/shortages/                        B. Scope and Terminology                              phrase ‘‘discontinuing manufacture’’
                                        default.htm.                                               Proposed § 314.81(b)(3)(iii)(a) states             does not refer to temporary cessations of
                                        III. Comments on the Proposed Rule                      that an applicant who is the sole                     manufacturing. We intend to apply the
                                                                                                manufacturer of an approved drug                      provisions of final § 314.81(b)(3)(iii) to
                                           We received written comments from                    product must notify FDA in writing at                 those instances where a manufacturer
                                        three pharmaceutical companies and a                    least 6 months before discontinuing                   has made a decision to no longer market
                                        patient advocacy organization. The                      manufacture of the drug product if that               a drug product that is life supporting,
                                        comments generally sought clarification                 drug product meets the following                      life sustaining, or intended for use in
                                        of terms and procedures described in                    criteria: (1) The drug product is life                the prevention of a serious disease or
                                        the proposed rule. Comments from the                    supporting, life sustaining, or intended              condition. The provisions of
                                        patient advocacy organization included                  for use in the prevention of a serious                § 314.81(b)(3)(iii) would not apply to
                                        suggestions for ensuring that patients                  disease or condition; and (2) the drug                situations described in the comment,
                                        affected by the withdrawal of a drug                    product was not originally derived from               such as temporary or intermittent
                                        product covered by this rule had                        human tissue and replaced by a                        manufacturing cessations due to
                                        sufficient opportunity to prepare for                   recombinant product.                                  planned or unplanned circumstances.
                                        alternative treatment options as needed.                   (Comment 3) One comment expressed                  Manufacturers who schedule a planned
                                        A summary of the comments received                      concern that while the ‘‘Orange Book’’                temporary manufacturing cessation but
                                        and our responses follow.                               (FDA’s publication on ‘‘Approved Drug                 do not intend to permanently
                                        A. General Comments                                     Products with Therapeutic Equivalence                 discontinue product manufacture are
                                                                                                Evaluations’’) lists all drug products                not subject to the provisions of this
                                          (Comment 1) One comment urged                         with approved NDAs and ANDAs, it is                   regulation. Normally, the supply of drug
                                        companies to voluntarily give notice to                 not possible to determine whether the                 product available to patients under
                                        the agency 1 year before discontinuing                  listed approved products are, in fact,                these circumstances would not be
                                        manufacture of a product, even though                   being manufactured. The comment                       affected during the period of the
                                        the act requires notification only 6                    therefore requested that we define sole               planned manufacturing cessation.
                                        months before discontinuance.                           manufacturer as ‘‘an applicant listed in              Similarly, manufacturers who
                                          Although we are retaining the 6-                      the Orange Book who is the holder of                  experience an unplanned temporary
                                        month notification period in the final                  the only listed approved application                  manufacturing interruption but intend
                                        rule, we agree that it would be                         under section 505(b) or (j) of the act.’’             to continue manufacturing over the long
                                        beneficial if companies could, when                        We decline to adopt this definition of             term are not subject to this rule. We
                                        possible, provide more than the 6-                      ‘‘sole manufacturer’’ for three reasons.              request that manufacturers who
                                        month notice required by statute.                       First, agency experience indicates that               experience such an unplanned
                                        Section 506C of the act and                             sole manufacturers generally know that                temporary manufacturing cessation keep
                                        § 314.81(b)(3)(iii) are clear that this is              they are a sole manufacturer. Second,                 the agency informed about the status of
                                        the minimum notification period, given                  while the Orange Book is routinely                    the shutdown because the duration of
                                        that they require ‘‘at least 6-months’’                 updated, there may be, on occasion,                   an unplanned shutdown may be
                                        notification (emphasis added). Earlier                  delays in updating it because, for                    unpredictable and could affect the
                                        notification is permitted, and FDA                      example, the agency may not always be                 availability of needed therapy for
                                        encourages companies to provide us                      notified about discontinuance of drug                 patients.
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                                        with as much advance notification as                    products in a timely fashion. Thus, the                  (Comment 5) In the preamble to the
                                        possible.                                               Orange Book would not be an                           proposed rule, we interpreted the
                                          (Comment 2) One comment asked                         appropriate singular source to                        phrase ‘‘life supporting or life
                                        FDA to urge companies that intend to                    determine which applicants are sole                   sustaining’’ drug as one that is essential
                                        discontinue the manufacture of                          manufacturers. The comment’s                          to, or that yields information that is


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                                        58996            Federal Register / Vol. 72, No. 201 / Thursday, October 18, 2007 / Rules and Regulations

                                        essential to, the restoration or                        C. Procedures                                         and regulatory scheme. These
                                        continuation of a bodily function                          (Comment 7) One comment stated                     provisions do not operate to limit the
                                        important to the continuation of human                  that a decision to discontinue                        period of continued marketing of the
                                        life (65 FR 66665 at 66666). One                        manufacturing a product could occur                   product. They simply require
                                        comment suggested that we incorporate                   ‘‘long after’’ the manufacturer produces              notification to FDA at least 6 months
                                        this interpretation into                                the last lot. The comment requested that              before cessation of manufacturing.
                                        § 314.81(b)(3)(iii).                                    we clarify when the applicant should                  Manufacturers may elect to give FDA
                                           We decline to incorporate this                                                                             notice of discontinuance more than 6
                                                                                                notify us in this situation. The comment
                                        interpretative language into the codified                                                                     months before manufacturing ceases.
                                                                                                does not provide any specific instances
                                        language in § 314.81(b)(3)(iii). The                                                                          Moreover, the length of time that a
                                                                                                where a decision to discontinue
                                        codified language parallels the statutory                                                                     product remains on the market may vary
                                                                                                manufacturing a product has occurred
                                        provision of section 506C(a) of the act.                                                                      with the amount of product in the
                                                                                                long after an applicant produced the last
                                        As the comment notes, the preamble to                                                                         supply chain at the time manufacturing
                                        the proposed rule defined the term ‘‘life               lot.
                                                                                                                                                      is discontinued. The statute and
                                                                                                   As we stated in response to comment
                                        supporting or life sustaining drug’’ as a                                                                     § 314.91(d)(6) provide that
                                                                                                4, we intend to apply the provisions of
                                        ‘‘drug product that is essential to, or that                                                                  demonstration of a manufacturer’s
                                                                                                § 314.81(b)(3)(iii) to those instances
                                        yields information that is essential to,                                                                      ability to continue distribution of a drug
                                        the restoration or continuation of a                    where a manufacturer has made a
                                                                                                                                                      product to satisfy existing market need
                                        bodily function important to the                        decision to no longer market a drug
                                                                                                                                                      for 6 months can be good cause for a
                                        continuation of human life’’ and                        product that is life supporting, life
                                                                                                                                                      reduction in the 6-month notification
                                        explained the definition’s origins.                     sustaining, or intended for use in the
                                                                                                                                                      period. Section 314.91(d)(6) may
                                        Rather than incorporating that language                 prevention of a serious disease or
                                                                                                                                                      shorten the minimum notification
                                        into the codified language, we intend to                condition. If the decision to discontinue
                                                                                                                                                      period, but only in situations where the
                                        rely on the interpretation described in                 manufacturing is not a temporary or                   applicant can continue distribution of
                                        the preamble to the proposed rule for                   intermittent manufacturing cessation,                 the drug product to satisfy existing
                                        guidance in applying that language.                     we would expect manufacturers covered                 market need for at least 6 months. In
                                           (Comment 6) One comment                              by this rule to notify the agency as soon             this circumstance, the product would
                                        contended that the scope of the                         as the decision has been made. We                     likely continue to be marketed for less
                                        language ‘‘intended for use in the                      would expect that manufacturers would                 than 12 months, i.e., the 6 months of
                                        prevention of a serious disease or                      ordinarily have notified the agency                   continued marketing plus some reduced
                                        condition’’ in proposed                                 before they had produced the last lot                 portion of the 6-month discontinuance
                                        § 314.81(b)(3)(iii)(a)(1) is too broad and              and that they will file a request for a               notification period.
                                        ambiguous. The comment expressed                        reduction of the 6-month notification                    (Comment 9) One comment urged
                                        concern that the phrase ‘‘intended for                  period if good cause exists for the                   FDA to put the onus on manufacturers
                                        use in prevention’’ could sweep into the                reduction.                                            to prove that reduction of the 6-month
                                        rule’s ambit drugs approved to treat less                  Under the scenario posed by the                    notification period will not cause
                                        serious conditions where the less                       comment, the rule would require                       substantial physical and emotional
                                        serious conditions are themselves a                     notification as soon as a decision not to             harm to the patients who rely on the
                                        contributing factor or risk factor in the               resume manufacturing the drug has                     drug. The same comment stated the
                                        development of a serious disease or                     been made (i.e., to convert a temporary               agency should create the highest
                                        condition. The comment suggested that                   shutdown to a permanent one). In                      hurdles for reducing the discontinuance
                                        the phrase should be amended to apply                   addition, the agency would expect                     notification period if the health and
                                        only to products that are ‘‘specifically                manufacturers in such circumstances to                welfare of patients are at stake.
                                        indicated in approved labeling for                      be able to demonstrate that the                          As reflected in the good cause
                                        prevention or prophylaxis of a disease                  shutdown was originally believed to be                provisions in § 314.91(d)(7), the statute
                                        or condition that is, or has the potential              only temporary and to explain the                     provides several specific circumstances
                                        in its fullest manifestation to be,                     change in circumstances.                              that may be considered good cause for
                                        chronically debilitating.’’                                (Comment 8) One comment requested                  reduction of the notification period,
                                           We disagree with the comment’s                       that we clarify whether the 6-month                   such as a public health problem that
                                        assertion that the phrase ‘‘intended for                notification period for discontinuing the             may result from continuation of
                                        use in the prevention of a serious                      manufacture of a product covered by                   manufacturing for the 6-month period; a
                                        disease or condition’’ is ambiguous or                  this regulation (under                                biomaterials shortage; a liability
                                        overly broad. In general, we do not                     § 314.81(b)(3)(iii)(a)) would run                     problem; economic hardship;
                                        expect that drug products used to treat                 consecutively with the 6 months of                    bankruptcy; or a manufacturer being
                                        relatively minor diseases or conditions                 continued marketing under new                         able to continue distribution for 6
                                        will fall within the scope of this rule                 § 314.91(d)(6). Under § 314.91(d)(6), an              months. We agree that there should be
                                        solely because there is a prophylactic                  applicant can establish good cause for a              a public health focus to establish good
                                        connection to a more serious disease or                 reduction in the notification period by               cause when requesting a reduction in
                                        illness—however tenuous. For instance,                  certifying that it can stop                           the discontinuance notification period.
                                        antihistamines that treat allergic rhinitis             manufacturing, but continue to                        Accordingly, we intend to apply the
                                        would not generally fall under this rule,               distribute the drug product to satisfy                provisions in § 314.91(d)(7), a broad
                                        even though allergic rhinitis may be a                  existing market need for 6 months. The                provision permitting reduction in the
                                        trigger for asthma, a more serious                      comment asked whether, in this                        notification period for ‘‘other good
                                        disease or condition. In contrast,                      ‘‘special instance,’’ the manufacturer                cause,’’ consistent with the public
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                                        products that are intended for use in                   would be ‘‘allowed 1 year of marketing                health concerns expressed in the
                                        treating or preventing asthma would                     after making the decision to withdraw                 comment. Manufacturers seeking to
                                        potentially fall under the scope of this                the product.’’                                        establish good cause for reasons other
                                        rule. Accordingly, we have not adopted                     We believe the comment has                         than those specifically enumerated
                                        the comment’s suggestion.                               misconstrued the nature of the statutory              under § 314.91(d)(1) through (d)(6) will


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                                                         Federal Register / Vol. 72, No. 201 / Thursday, October 18, 2007 / Rules and Regulations                                       58997

                                        be expected to demonstrate that                         314.91(c)(3) of the proposed rule,                    manufacturer, we certify that the final
                                        reducing the discontinuance                             manufacturers of drugs regulated by                   rule will not have a significant
                                        notification period will not result in                  CBER are not required to send the                     economic impact on a substantial
                                        increased risk of harm to the health of                 notification of discontinuance to the                 number of small entities.
                                        patients who use the drug.                              Drug Listing Branch, as are                              Section 202(a) of the Unfunded
                                           (Comment 10) One comment asked                       manufacturers of drugs regulated by                   Mandates Reform Act of 1995 requires
                                        about the relationship between                          CDER.                                                 that agencies prepare a written
                                        notification of discontinuance of                          We agree that the requirement should               statement, which includes an
                                        manufacturing under this rule and                       be the same for drugs regulated by CBER               assessment of anticipated costs and
                                        removing a withdrawn product from the                   and CDER. For administrative                          benefits, before proposing ‘‘any rule that
                                        list of drugs submitted for purposes of                 efficiency, we have revised                           includes any Federal mandate that may
                                        drug registration and listing. Under                    §§ 314.81(b)(3)(iii)(b) and 314.91(c)(3) to           result in the expenditure by State, local,
                                        current § 314.81(b)(3)(iii) (redesignated               make the procedures for manufacturers                 and tribal governments, in the aggregate,
                                        as § 314.81(b)(3)(iv) by this rulemaking),              to submit a notice of discontinuance (or              or by the private sector, of $100,000,000
                                        an applicant must submit Form FDA                       a request for reduction in the                        or more (adjusted annually for inflation)
                                        2657 (Drug Product Listing) to the Drug                 discontinuance notification period) the               in any one year.’’ The current threshold
                                        Registration and Listing Team, Division                 same for drugs, whether they are                      after adjustment for inflation is $127
                                        of Compliance Risk Management and                       regulated by CDER or CBER. As revised,                million, using the most current (2006)
                                        Surveillance (formerly the Drug Listing                 for all drugs subject to this rule,                   Implicit Price Deflator for the Gross
                                        Branch1), in CDER within 15 working                     manufacturers must send notifications                 Domestic Product. We do not expect
                                        days of the withdrawal from sale of a                   of discontinuance or requests for                     this final rule to result in any 1-year
                                        drug product.2 The submission of this                   reduction in notification periods, to the             expenditure that would meet or exceed
                                        form notifies us that the drug product is               following designated CDER and CBER                    this amount.
                                        no longer being marketed. The comment                   offices: (1) The CDER Drug Shortage                      The final rule requires that
                                        requested that we clarify whether                       Coordinator, at the address of the                    manufacturers of certain drug products
                                        sending the notice of discontinuation of                Director of CDER; (2) the CDER Drug                   notify the agency at least 6 months
                                        manufacturing to the Drug Listing                       Registration and Listing Team, Division               before discontinuing their manufacture.
                                        Branch will result in the delisting of the              of Compliance Risk Management and                     As explained in section V of this
                                        product, or whether additional                          Surveillance; and (3) either the director             document, the regulatory conditions
                                        correspondence with the Drug Listing                    of the review division in CDER that is                that trigger this requirement occur only
                                        Branch will be required.                                responsible for reviewing the                         infrequently. Based on agency
                                           The delisting process is separate from               application or the director of the office             experience, we estimate that such
                                        the notification of discontinuance                      in CBER that is responsible for                       circumstances occur no more than once
                                        process described in this rule. The                     reviewing the application. This final                 per year. Moreover, the notification
                                        notification of discontinuance is                       rule eliminates the proposed                          requirement will impose a significant
                                        submitted under this rule at least 6                    requirement to notify the Director of                 burden only when market conditions
                                        months before cessation of                              CBER for drug products regulated by                   deteriorate so quickly that firms could
                                        manufacturing. The notice of                            CBER.                                                 not foresee the desired action 6 months
                                        discontinuance does not take the place                     We encourage manufacturers who                     in advance. Most pharmaceutical firms
                                        of a listing update submitted on a Form                 have questions about these processes to               rely on established long-term marketing
                                        FDA 2657. In most cases where                           contact the Drug Shortage Coordinator                 plans.
                                        manufacturing is discontinued, the drug                 at CDER.                                                 Under certain specified
                                        will continue to be marketed for at least                                                                     circumstances, the rule permits us to
                                                                                                IV. Analysis of Impacts                               reduce the notification period for good
                                        6 months or more and should remain
                                        listed during that time. The Form 2657                     We have examined the impacts of the                cause. Manufacturers can request a
                                        would need to be submitted later,                       final rule under Executive Order 12866                reduced notification period by
                                        within 15 days of withdrawal from the                   and the Regulatory Flexibility Act (5                 submitting a written certification, based
                                        market of the drug, under current                       U.S.C. 601–612), and the Unfunded                     on considerations such as public health,
                                        § 314.81(b)(3)(iii) (redesignated as                    Mandates Reform Act of 1995 (Public                   legal liability, biomaterial shortage, or
                                        § 314.81(b)(3)(iv) in this rule). In                    Law 104–4). Executive Order 12866                     substantial economic hardship. A
                                        addition, while all drugs are subject to                directs agencies to assess all costs and              certification of substantial economic
                                        the listing requirements, the                           benefits of available regulatory                      hardship will need to be supported by
                                        discontinuance provision applies only                   alternatives and, when regulation is                  evidence demonstrating that the
                                        to those instances where the                            necessary, to select regulatory                       reduced notification period is necessary
                                        manufacturing of a single-source drug                   approaches that maximize net benefits                 to avoid substantial economic hardship
                                        product that is life supporting, life                   (including potential economic,                        to the manufacturer.
                                        sustaining, or intended for use in the                  environmental, public health and safety,
                                                                                                and other advantages; distributive                    V. Paperwork Reduction Act of 1995
                                        prevention of a serious disease or
                                        condition, will be discontinued.                        impacts; and equity). We believe that                   This final rule contains information
                                           (Comment 11) One comment asked                       this final rule is not a significant                  collection provisions that are subject to
                                        why, under §§ 314.81(b)(3)(iii)(b) and                  regulatory action under the Executive                 review by the Office of Management and
                                                                                                order.                                                Budget (OMB) under the Paperwork
                                          1 The former Drug Listing Branch has been                The Regulatory Flexibility Act                     Reduction Act of 1995 (44 U.S.C. 3501–
                                        reorganized as the Drug Registration and Listing        requires agencies to analyze regulatory               3520). The title, description, and
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                                        Team, Division of Compliance Risk Management            options that would minimize any                       respondent description of the
                                        and Surveillance, in CDER’s Office of Compliance.       significant impact of a rule on small                 information collection provisions are
                                          2 In the Federal Register of August 29, 2006 (71

                                        FR 51276), we published a proposed rule that
                                                                                                entities. Because the final rule will                 shown in the following paragraphs with
                                        would amend § 314.81(b)(3)(iii) to provide 30-days      result in minimal additional costs in                 an estimate of the annual reporting
                                        for submission of Form FDA 2657.                        about one instance per year to one                    burden. Included in the estimate is the


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                                        58998            Federal Register / Vol. 72, No. 201 / Thursday, October 18, 2007 / Rules and Regulations

                                        time for reviewing instructions,                        offices to ensure that our efforts                    for use in the prevention of a serious
                                        searching existing data sources,                        regarding the discontinuation of the                  disease or condition; (2) was approved
                                        gathering and maintaining the data                      product are commenced in a timely                     by FDA under section 505(b) or (j) of the
                                        needed, and completing and reviewing                    manner. We will work with members of                  act; and (3) was not originally derived
                                        each collection of information. OMB                     the industry and with the applicant                   from human tissue and replaced by
                                        and FDA received no comments                            during the 6-month notification period                recombinant product.
                                        concerning the information collection                   to ease patient transition from the drug                 Burden Estimate: Table 1 of this
                                        provisions of the proposed rule.                        that will be discontinued to alternate                document provides an estimate of the
                                          Title: Applications for FDA Approval                  therapy.                                              annual reporting burden for notification
                                        to Market a New Drug; Revision of                                                                             of product discontinuance and
                                        Postmarketing Reporting Requirements                    B. Certification of Good Cause                        certification of good cause under this
                                          Description: The final rule                              We may reduce the 6-month                          rule.
                                        implements section 506C of the act and                  notification period if we find good cause                Notification of Discontinuance: Based
                                        requires applicants who are the sole                    for the reduction. As described in                    on data collected from the CDER drug
                                        manufacturers of certain drug or                        section 506C(b) of the act and new                    shortage coordinator, CDER review
                                        biologic products to notify us at least 6               § 314.91, an applicant can request a                  divisions, and CBER review offices
                                        months before discontinuing the                         reduction in the notification period for              during 2003 through 2006, one
                                        manufacture of the product. For the rule                good cause by submitting written                      applicant during each year discontinued
                                        to apply, a product needs to meet the                   certification to the following designated             the manufacture of one product meeting
                                        following three criteria:                               offices: (1) The CDER Drug Shortage                   the criteria of section 506C of the act.
                                          (1) The product must be life                          Coordinator at the address of the                     Each applicant meeting the criteria is
                                        supporting, life sustaining, or intended                Director of CDER; (2) the CDER Drug                   required under final § 314.81(b)(3)(iii) to
                                        for use in the prevention of a serious                  Registration and Listing Team, Division               notify the agency of the discontinuance
                                        disease or condition;                                   of Compliance Risk Management and                     at least 6 months before manufacturing
                                          (2) The product must have been                        Surveillance in CDER; and (3) the                     ceased. Although the procedures for
                                        approved by FDA under section 505(b)                    director of either the CDER division or               notifying the agency that are set forth in
                                        or 505(j) of the act; and                               the CBER office that is responsible for               the final rule were not in place during
                                          (3) The product must not have been                    reviewing the application, that good                  2003 through 2006, we estimate that the
                                        originally derived from human tissue                    cause exists as follows:                              number of manufacturers who would be
                                        and replaced by a recombinant product.                     • A public health problem may result               required to notify us of discontinuance
                                          The rule allows us to reduce the 6-                   from continuation of manufacturing for                would remain the same. Therefore, the
                                        month notification period if we find                    the 6-month period (§ 314.91(d)(1));                  number of respondents is estimated to
                                        good cause for the reduction. An                           • A biomaterials shortage prevents                 be one. The total annual responses are
                                        applicant may request that we reduce                    the continuation of manufacturing for                 the total number of notifications of
                                        the notification period by certifying that              the 6-month period (§ 314.91(d)(2));                  discontinuance that are expected to be
                                        good cause for the reduction exists.                       • A liability problem may exist for                submitted to CDER or CBER in a year.
                                        Under the rule, we will also publicly                   the manufacturer if the manufacturing is              During 2003 through 2006, an applicant
                                        disclose information about the drugs                    continued for the 6-month period                      would have been required to notify us
                                        that are discontinued under the rule.                   (§ 314.91(d)(3));                                     annually of one product discontinuance
                                        Existing regulations, which appear in                      • Continuation of the manufacturing                under the procedures. We estimate that
                                        part 314, establish postmarketing                       for the 6-month period may cause                      the total annual responses will remain
                                        reporting requirements for approved                     substantial economic hardship for the                 the same, averaging one response per
                                        drugs. Current § 314.81(b)(3)(iii) (OMB                 manufacturer (§ 314.91(d)(4));                        respondent. The hours per response is
                                        control no. 0910–0001), which is                           • The manufacturer has filed for                   the estimated number of hours that a
                                        redesignated as § 314.81(b)(3)(iv) in this              bankruptcy under chapter 7 or 11 of title             respondent would spend preparing the
                                        rule, requires an applicant to notify us                11, United States Code (§ 314.91(d)(5));              information to be submitted with a
                                        within 15 working days of withdrawing                      • The manufacturer can stop making                 notification of product discontinuance,
                                        a drug product from sale. This rule adds                the product but still distribute it to                including the time it takes to gather and
                                        two new reporting requirements.                         satisfy existing market need for 6                    copy the statement. Based on experience
                                                                                                months (§ 314.91(d)(6)); or                           in working with applicants regarding
                                        A. Notification of Discontinuance
                                                                                                   • Other good cause exists for a                    similar collections of information, we
                                          Under this rule, at least 6 months                    reduction in the notification period                  estimate that approximately 2 hours on
                                        before an applicant intends to                          (§ 314.91(d)(7)).                                     average are needed per response.
                                        discontinue manufacture of a product,                      With each certification described                  Therefore, we estimate that 2 hours will
                                        the applicant must send us written                      previously, the applicant must describe               be spent per year by respondents
                                        notification of the discontinuance. For                 in detail the basis for the applicant’s               notifying us of a product discontinuance
                                        drugs regulated by CDER or CBER,                        conclusion that such circumstances                    under these regulations.
                                        manufacturers must send notifications                   exist. We require that the written                       Certification of Good Cause: Based on
                                        of discontinuance to the following                      certification that good cause exists be               data collected from the CDER drug
                                        designated offices: (1) The CDER Drug                   submitted to the offices identified                   shortage coordinator, CDER review
                                        Shortage Coordinator at the address of                  previously to ensure that our efforts                 divisions, and CBER review offices
                                        the Director of CDER; (2) the CDER Drug                 regarding the discontinuation take place              during 2003 through 2006, one
                                        Registration and Listing Team, Division                 in a timely manner.                                   applicant discontinued during each year
                                        of Compliance Risk Management and                          Description of Respondents: An                     the manufacture of one product meeting
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                                        Surveillance in CDER; and (3) the                       applicant who is the sole manufacturer                the criteria of section 506C of the act.
                                        director of either the CDER division or                 and who intends to discontinue                        Each applicant has the opportunity
                                        the CBER office that is responsible for                 marketing of a drug product that meets                under § 314.91 to request a reduction in
                                        reviewing the application. We require                   the following criteria: (1) Is life                   the 6-month notification period by
                                        that the notification be sent to these                  supporting, life sustaining, or intended              certifying to us that good cause exists


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                                                         Federal Register / Vol. 72, No. 201 / Thursday, October 18, 2007 / Rules and Regulations                                         58999

                                        for the reduction. We do not expect that                submitted to us in a year. We estimate                 Based on experience in working with
                                        each eligible applicant will certify that               that the total annual responses will                   applicants regarding similar collections
                                        good cause exists for a reduction.                      remain small, averaging one response                   of information, we estimate that
                                        Furthermore, the number of applicants                   per respondent. The hours per response                 approximately 16 hours on average are
                                        who are in a position to request a                      is the estimated number of hours that a                needed per response. Therefore, we
                                        reduction is quite small. Therefore, the                respondent spends preparing the                        estimate that 16 hours will be spent per
                                        number of respondents is estimated to                   detailed information certifying that good              year by respondents certifying that good
                                        be one. The total annual responses are                  cause exists for a reduction in the                    cause exists for a reduction in the 6-
                                        the total number of notifications of                    notification period, including the time it             month notification period under
                                        discontinuance that are expected to be                  takes to gather and copy the documents.                § 314.91.

                                                                                       TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
                                                                                              No. of              No. of Responses          Total Annual          Hours per
                                                      21 CFR Section                                                                                                               Total Hours
                                                                                           Respondents             per Respondent            Responses            Response

                                          Notification of Discontinuance
                                          (§ 314.81(b)(3)(iii))                                            1                        1                      1                  2                   2

                                          Certification of Good Cause
                                          (§ 314.91)                                                      10                        1                      1                  16                 16

                                          Total                                                                                                                                                  18
                                           1There   are no capital costs or operating and maintenance costs associated with this collection of information.


                                          The information collection provisions                 List of Subjects in 21 CFR Part 314                    for use in the prevention of a serious
                                        of this final rule have been submitted to                 Administrative practice and                          disease or condition; and
                                        OMB for review.                                         procedure, Confidential business                          (2) The drug product was not
                                          Prior to the effective date of this final             information, Drugs, Reporting and                      originally derived from human tissue
                                        rule, FDA will publish a notice in the                  recordkeeping requirements.                            and replaced by a recombinant product.
                                        Federal Register announcing OMB’s                                                                                 (b) For drugs regulated by the Center
                                                                                                ■ Therefore, under the Federal Food,                   for Drug Evaluation and Research
                                        decision to approve, modify, or                         Drug, and Cosmetic Act, the Public
                                        disapprove the information collection                                                                          (CDER) or the Center for Biologics
                                                                                                Health Service Act, and under authority                Evaluation and Research (CBER), one
                                        provisions of this final rule. An agency                delegated to the Commissioner of Food                  copy of the notification required by
                                        may not conduct or sponsor, and a                       and Drugs, 21 CFR part 314 is amended                  paragraph (b)(3)(iii)(a) of this section
                                        person is not required to respond to, a                 as follows:                                            must be sent to the CDER Drug Shortage
                                        collection of information unless it
                                                                                                                                                       Coordinator, at the address of the
                                        displays a currently valid OMB control                  PART 314—APPLICATIONS FOR FDA
                                                                                                                                                       Director of CDER; one copy to the CDER
                                        number.                                                 APPROVAL TO MARKET A NEW DRUG
                                                                                                                                                       Drug Registration and Listing Team,
                                        VI. Federalism                                          ■ 1. The authority citation for 21 CFR                 Division of Compliance Risk
                                                                                                part 314 is revised to read as follows:                Management and Surveillance; and one
                                          We have analyzed this final rule in                                                                          copy to either the director of the review
                                        accordance with the principles set forth                  Authority: 21 U.S.C. 321, 331, 351, 352,             division in CDER that is responsible for
                                        in Executive Order 13132. We have                       353, 355, 356, 356a, 356b, 356c, 371, 374,
                                                                                                379e.
                                                                                                                                                       reviewing the application, or the
                                        determined that the rule does not                                                                              director of the office in CBER that is
                                        contain policies that have substantial                  ■  2. Section 314.81 is amended as                     responsible for reviewing the
                                        direct effects on the States, on the                    follows:                                               application.
                                        relationship between National                           ■ a. Redesignate paragraph (b)(3)(iii) as
                                                                                                                                                          (c) FDA will publicly disclose a list of
                                        Government and the States, or on the                    (b)(3)(iv);                                            all drug products to be discontinued
                                        distribution of power and                               ■ b. Remove from newly redesignated
                                                                                                                                                       under paragraph (b)(3)(iii)(a) of this
                                        responsibilities among the various                      paragraph (b)(3)(iv)(c) the phrase
                                                                                                                                                       section. If the notification period is
                                        levels of government. Accordingly, we                   ‘‘(b)(3)(iii)’’ and add in its place the
                                                                                                                                                       reduced under § 314.91, the list will
                                        have concluded that the rule does not                   phrase ‘‘(b)(3)(iv)’’; and
                                                                                                ■ c. Add new paragraph (b)(3)(iii) to
                                                                                                                                                       state the reason(s) for such reduction
                                        contain policies that have federalism                                                                          and the anticipated date that
                                        implications as defined in the Executive                read as follows:
                                                                                                   The addition reads as follows:                      manufacturing will cease.
                                        order, and, consequently, a federalism                                                                         *      *     *    *     *
                                        summary impact statement is not                         § 314.81 Other postmarketing reports.                  ■ 3. Section 314.91 is added to subpart
                                        required.                                               *      *    *      *    *                              B to read as follows:
                                        VII. Environmental Impact                                 (b) * * *
                                                                                                  (3) * * *                                            § 314.91 Obtaining a reduction in the
                                          We have determined under 21 CFR                         (iii) Notification of discontinuance.                discontinuance notification period.
                                        25.30(h) that this action is of a type that             (a) An applicant who is the sole                         (a) What is the discontinuance
                                        does not individually or cumulatively                   manufacturer of an approved drug                       notification period? The discontinuance
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                                        have a significant effect on the human                  product must notify FDA in writing at                  notification period is the 6-month
                                        environment. Therefore, neither an                      least 6 months prior to discontinuing                  period required under
                                        environmental assessment nor an                         manufacture of the drug product if:                    § 314.81(b)(3)(iii)(a). The
                                        environmental impact statement is                         (1) The drug product is life                         discontinuance notification period
                                        required.                                               supporting, life sustaining, or intended               begins when an applicant who is the


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                                        59000            Federal Register / Vol. 72, No. 201 / Thursday, October 18, 2007 / Rules and Regulations

                                        sole manufacturer of certain products                   for reviewing the application, or the                 DEPARTMENT OF HEALTH AND
                                        notifies FDA that it will discontinue                   director of the office in CBER                        HUMAN SERVICES
                                        manufacturing the product. The                          responsible for reviewing the
                                        discontinuance notification period ends                 application.                                          Food and Drug Administration
                                        when manufacturing ceases.                                 (d) What circumstances and
                                           (b) When can FDA reduce the                                                                                21 CFR Part 600
                                                                                                information can establish good cause
                                        discontinuance notification period?
                                                                                                for a reduction in the discontinuance
                                        FDA can reduce the 6-month                                                                                    [Docket No. 2007N–0284]
                                        discontinuance notification period                      notification period? (1) A public health
                                        when it finds good cause exists for the                 problem may result from continuation                  Revision of the Requirements for Live
                                        reduction. FDA may find good cause                      of manufacturing for the 6-month                      Vaccine Processing 

                                        exists based on information certified by                period. This certification must include a
                                        an applicant in a request for a reduction               detailed description of the potential                 AGENCY:    Food and Drug Administration, 

                                        of the discontinuance notification                      threat to the public health.                          HHS. 

                                        period. In limited circumstances, FDA                      (2) A biomaterials shortage prevents               ACTION:   Direct final rule.
                                        may find good cause exists based on                     the continuation of the manufacturing
                                                                                                                                                      SUMMARY: The Food and Drug
                                        information already known to the                        for the 6-month period. This
                                        agency. These circumstances can                                                                               Administration (FDA) is amending the
                                                                                                certification must include a detailed                 biologics regulations by providing
                                        include the withdrawal of the drug from                 description of the steps taken by the
                                        the market based upon formal FDA                                                                              options to the existing requirement for
                                                                                                applicant in an attempt to secure an                  the processing of live vaccines. FDA is
                                        regulatory action (e.g., under the                      adequate supply of biomaterials to
                                        procedures described in § 314.150 for                                                                         amending the regulations due to
                                                                                                enable manufacturing to continue for                  advances in technology that will allow
                                        the publication of a notice of                          the 6-month period and an explanation
                                        opportunity for a hearing describing the                                                                      processing of live vaccines to be
                                                                                                of why the biomaterials could not be                  performed in multiproduct
                                        basis for the proposed withdrawal of a
                                                                                                secured.                                              manufacturing areas. We are publishing
                                        drug from the market) or resulting from
                                        the applicant’s consultations with the                     (3) A liability problem may exist for              this rule because the existing
                                        agency.                                                 the manufacturer if the manufacturing is              requirement regarding facilities and
                                           (c) How can an applicant request a                   continued for the 6-month period. This                equipment for live vaccine processing is
                                        reduction in the discontinuance                         certification must include a detailed                 too prescriptive and is no longer
                                        notification period? (1) The applicant                  description of the potential liability                necessary. We are taking this action as
                                        must certify in a written request that, in              problem.                                              part of our continuing effort to reduce
                                        its opinion and to the best of its                                                                            the burden of unnecessary regulations
                                                                                                   (4) Continuation of the manufacturing              on industry and to revise outdated
                                        knowledge, good cause exists for the                    for the 6-month period may cause
                                        reduction. The applicant must submit                                                                          regulations without diminishing public
                                                                                                substantial economic hardship for the                 health protection. Elsewhere in this
                                        the following certification:                            manufacturer. This certification must
                                           The undersigned certifies that good cause                                                                  issue of the Federal Register, we are
                                        exists for a reduction in the 6-month                   include a detailed description of the                 publishing a companion proposed rule
                                        notification period required in                         financial impact of continuing to                     under our usual procedures for notice
                                        § 314.81(b)(3)(iii)(a) for discontinuing the            manufacture the drug product over the                 and comment in the event that we
                                        manufacture of (name of the drug product).              6-month period.                                       receive any significant adverse
                                        The following circumstances establish good                                                                    comments on the direct final rule. If we
                                        cause (one or more of the circumstances in                 (5) The manufacturer has filed for
                                                                                                bankruptcy under chapter 7 or 11 of title             receive any significant adverse
                                        paragraph (d) of this section).
                                                                                                11, United States Code (11 U.S.C. 701 et              comments that warrant terminating the
                                          (2) The certification must be signed by                                                                     direct final rule, we will consider such
                                        the applicant or the applicant’s attorney,              seq. and 1101 et seq.). This certification
                                                                                                                                                      comments on the proposed rule in
                                        agent (representative), or other                        must be accompanied by documentation
                                                                                                                                                      developing the final rule.
                                        authorized official. If the person signing              of the filing or proof that the filing
                                        the certification does not reside or have               occurred.                                             DATES: This rule is effective March 18,
                                        a place of business within the United                                                                         2008. Submit written or electronic
                                                                                                   (6) The manufacturer can continue                  comments by January 2, 2008. If we
                                        States, the certification must contain the              distribution of the drug product to
                                        name and address of, and must also be                                                                         receive no significant adverse comments
                                                                                                satisfy existing market need for 6                    during the specified comment period,
                                        signed by, an attorney, agent, or other                 months. This certification must include
                                        authorized official who resides or                                                                            we intend to publish a confirmation
                                                                                                a detailed description of the                         document on or before the effective date
                                        maintains a place of business within the
                                                                                                manufacturer’s processes to ensure such               of this direct final rule confirming that
                                        United States.
                                                                                                distribution for the 6-month period.                  the direct final rule will go into effect
                                          (3) For drugs regulated by the Center
                                        for Drug Evaluation and Research                           (7) Other good cause exists for the                on March 18, 2008. If we receive any
                                        (CDER) or the Center for Biologics                      reduction. This certification must                    significant adverse comments during the
                                        Evaluation and Research (CBER), one                     include a detailed description of the                 comment period, we intend to withdraw
                                        copy of the certification must be                       need for a reduction.                                 this direct final rule before its effective
                                        submitted to the Drug Shortage                                                                                date by publication of a notice in the
                                                                                                  Dated: October 5, 2007.                             Federal Register.
                                        Coordinator at the address of the
                                                                                                Jeffrey Shuren,
                                        Director of CDER, one copy to the CDER                                                                        ADDRESSES: You may submit comments,
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                                        Drug Registration and Listing Team,                     Assistant Commissioner for Policy.                    identified by Docket No. 2007N–0284,
                                        Division of Compliance Risk                             [FR Doc. E7–20510 Filed 10–17–07; 8:45 am]            by any of the following methods:
                                        Management and Surveillance in CDER,                    BILLING CODE 4160–01–S                                Electronic Submissions
                                        and one copy to either the director of                                                                           Submit electronic comments in the
                                        the review division in CDER responsible                                                                       following ways:


                                   VerDate Aug<31>2005   14:36 Oct 17, 2007   Jkt 214001   PO 00000   Frm 00008   Fmt 4700   Sfmt 4700   E:\FR\FM\18OCR1.SGM   18OCR1

								
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