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									                                          10224                        Federal Register / Vol. 72, No. 44 / Wednesday, March 7, 2007 / Notices

                                            Dated: February 27, 2007.                             Administration, 5600 Fishers Lane,                    FR 24606, May 10, 2005). The draft
                                          Jeffrey Shuren,                                         Rockville, MD 20857, 301–443–5570.                    guidance described a proposal to
                                          Assistant Commissioner for Policy.                      SUPPLEMENTARY INFORMATION:                            establish a new communication
                                          [FR Doc. E7–3915 Filed 3–6–07; 8:45 am]                                                                       channel, called the ‘‘Drug Watch’’ Web
                                                                                                  I. Background                                         page, to provide information to the
                                          BILLING CODE 4160–01–S
                                                                                                     FDA is announcing the availability of              public on emerging drug safety issues.
                                                                                                  a guidance entitled ‘‘Drug Safety                     In December 2005, FDA held a public
                                          DEPARTMENT OF HEALTH AND                                Information—FDA’s Communication to                    hearing regarding ‘‘FDA’s
                                          HUMAN SERVICES                                          the Public.’’ This guidance describes                 Communication of Drug Safety
                                                                                                  FDA’s current approach to                             Information’’ that examined the various
                                          Food and Drug Administration                            communicating important drug safety                   risk communication tools employed by
                                                                                                  information, including emerging drug                  FDA. FDA has carefully reviewed the
                                          [Docket No. 2005D–0062]
                                                                                                  safety information, to the public and the             comments it received on the draft
                                          Guidance on Drug Safety                                 factors that influence when such                      guidance (30 comments were submitted
                                          Information—Food and Drug                               information is communicated.                          to the public docket) and during the
                                          Administration’s Communication to                          For many years, FDA has provided                   public hearing. This final version of the
                                          the Public; Availability                                information on drug risks and benefits                guidance reflects our consideration of
                                                                                                  to healthcare professionals and patients              these comments, as well as our
                                          AGENCY:    Food and Drug Administration,                when that information has generated a                 experience with posting emerging drug
                                          HHS.                                                    specific concern or prompted a                        safety information.
                                          ACTION:   Notice.                                       regulatory action, such as a revision to                 Due to potential confusion between
                                                                                                  the drug product’s labeling. FDA has                  the proposed ‘‘Drug Watch’’ and FDA’s
                                          SUMMARY: The Food and Drug                              been reexamining its risk                             existing ‘‘MedWatch’’ program, FDA no
                                          Administration (FDA) is announcing the                  communication program, including how                  longer plans to use the name ‘‘Drug
                                          availability of a guidance titled ‘‘Drug                and when we communicate emerging                      Watch’’ to describe the Web page that
                                          Safety Information—FDA’s                                drug safety information to the public.                contains drug safety information. We
                                          Communication to the Public.’’ This                     More recently, FDA has begun taking a                 have identified drugs that have been the
                                          guidance describes FDA’s current                        more comprehensive approach to                        subject of a Public Health Advisory or
                                          approach to communicating important                     making information on potential drug                  an Alert on a single Web page, the Index
                                          drug safety information, including                      risks available to the public earlier, in             to Drug-Specific Information, linked
                                          emerging drug safety information, to the                some cases while the agency still is                  from FDA’s Web site. This is part of our
                                          public and the factors that influence                   evaluating whether any regulatory                     ongoing effort to use and enhance
                                          when such information is                                action is warranted. FDA believes that                existing FDA communications
                                          communicated. This guidance was                         timely communication of important                     mechanisms to better convey important
                                          developed in connection with FDA’s                      drug safety information will give                     drug safety information to the public. In
                                          Drug Safety Initiative. This guidance is                healthcare professionals, patients,                   addition, we have revised this guidance
                                          the final version and supersedes the                    consumers, and other interested persons               to describe the various methods FDA
                                          previously issued draft guidance titled                 access to the most current information                currently uses to communicate
                                          ‘‘FDA’s Drug Watch for Emerging Drug                    concerning the potential risks and                    established and emerging drug safety
                                          Safety Information’’ (70 FR 24606, May                  benefits of a marketed drug, helping                  information to the public. It should be
                                          10, 2005).                                              them to make more informed individual                 noted that we will continue to evaluate
                                          DATES: Submit written or electronic                     treatment choices.                                    and enhance the effectiveness of the
                                          comments on agency guidances at any                        FDA’s risk communication efforts are               various methods we use to
                                          time.                                                   part of a larger drug safety initiative that          communicate about important drug
                                                                                                  began in November 2004, when FDA                      safety issues, including the mechanisms
                                          ADDRESSES: Submit written requests for
                                                                                                  announced an initiative to strengthen                 described in this guidance and the
                                          single copies of this guidance to the
                                                                                                  the safety program for marketed drugs.                presentation of drug safety information
                                          Division of Drug Information (HFD–
                                                                                                  This initiative included the following:               on the Agency Web sites (http://
                                          240), Center for Drug Evaluation and
                                                                                                  (1) Sponsoring an independent study by                www.fda.gov and http://www.fda.gov/
                                          Research, Food and Drug
                                                                                                  the Institute of Medicine of the National             cder). We intend to update this
                                          Administration, 5600 Fishers Lane,                      Academies of the effectiveness of the
                                          Rockville, MD 20857. Send one self-                                                                           guidance, as appropriate, to reflect any
                                                                                                  drug safety system, with emphasis on                  substantial modifications to our
                                          addressed adhesive label to assist that                 postmarketing risk assessment and
                                          office in processing your requests.                                                                           communication of drug safety
                                                                                                  surveillance; (2) conducting workshops                information to the public.
                                          Submit written comments on the                          and Advisory Committee meetings                          This guidance is being issued
                                          guidance to the Division of Dockets                     regarding complex drug safety and risk                consistent with FDA’s good guidance
                                          Management (HFA–305), Food and Drug                     management issues, including emerging                 practices regulation (21 CFR 10.115).
                                          Administration, 5630 Fishers Lane, rm.                  concerns; and (3) publishing three risk               The guidance represents the agency’s
                                          1061, Rockville, MD 20852. Submit                       management guidances. FDA                             current thinking on this topic. It does
                                          electronic comments to http://                          augmented its drug safety initiative in               not create or confer any rights for or on
                                          www.fda.gov/dockets/ecomments. See                      February 2005 by creating an                          any person and does not operate to bind
                                          the SUPPLEMENTARY INFORMATION section                   independent Drug Safety Oversight                     FDA or the public.
                                          for electronic access to the guidance                   Board to enhance oversight of drug
                                          document.                                               safety decision making within the                     II. Comments
sroberts on PROD1PC70 with NOTICES




                                          FOR FURTHER INFORMATION CONTACT: Paul                   Center for Drug Evaluation and Research                  Interested persons may submit to the
                                          J. Seligman, Associate Director for                     (CDER).                                               Division of Dockets Management (see
                                          Safety Policy and Communication,                           In May 2005, FDA issued a draft                    ADDRESSES) written or electronic
                                          Center for Drug Evaluation and Research                 guidance titled ‘‘FDA’s Drug Watch for                comments regarding this document.
                                          (HFD–001), Food and Drug                                Emerging Drug Safety Information’’ (70                Submit a single copy of electronic


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                                                                           Federal Register / Vol. 72, No. 44 / Wednesday, March 7, 2007 / Notices                                                   10225

                                          comments or two paper copies of any                            DEPARTMENT OF HEALTH AND                                 on respondents, including through the
                                          mailed comments, except that                                   HUMAN SERVICES                                           use of automated collection techniques
                                          individuals may submit one paper copy.                                                                                  or other forms of information
                                          Comments are to be identified with the                         Health Resources and Services                            technology.
                                          docket number found in brackets in the                         Administration                                             Proposed Project: Application for the
                                          heading of this document. Received                             Agency Information Collection                            National Health Service Corps (NHSC)
                                          comments may be seen in the Division                           Activities: Proposed Collection;                         Clinician Retention Information: New
                                          of Dockets Management between 9 a.m.                           Comment Request                                          Collection
                                          and 4 p.m., Monday through Friday.                                                                                        The National Health Service Corps
                                                                                                            In compliance with the requirement                    (NHSC) of the Bureau of Health
                                          III. Paperwork Reduction Act of 1995                           for opportunity for public comment on                    Professions (BHPr), HRSA, is committed
                                                                                                         proposed data collection projects                        to improving the health of the Nation’s
                                            This guidance refers to previously
                                                                                                         (section 3506(c)(2)(A) of Title 44, United               underserved by uniting communities in
                                          approved collections of information                            States Code, as amended by the
                                          found in FDA regulations. These                                                                                         need with caring health professionals
                                                                                                         Paperwork Reduction Act of 1995, Pub.                    and by supporting communities’ efforts
                                          collections of information are subject to                      L. 104–13), the Health Resources and
                                          review by the Office of Management and                                                                                  to build better systems of care.
                                                                                                         Services Administration (HRSA)
                                          Budget (OMB) under the Paperwork                                                                                          The NHSC is responsible for
                                                                                                         publishes periodic summaries of
                                          Reduction Act of 1995 (44 U.S.C. 3501–                         proposed projects being developed for                    collecting data on its programs to ensure
                                          3520). The collections of information in                       submission to the Office of Management                   compliance with legislative mandates
                                          21 CFR 310.305, 314.80, 314.98, and                            and Budget under the Paperwork                           and to report to Congress and
                                          600.80 have been approved under OMB                            Reduction Act of 1995. To request more                   policymakers on program
                                          control numbers 0910–0230, 0910–0291,                          information on the proposed project or                   accomplishments. One of the most
                                                                                                         to obtain a copy of the data collection                  important statistics reported to Congress
                                          and 0910–0308.
                                                                                                         plans and draft instruments, call the                    and policymakers is the retention rate of
                                          IV. Electronic Access                                          HRSA Reports Clearance Officer on                        NHSC supported clinicians serving in
                                                                                                         (301) 443–1129.                                          an underserved area. The following
                                            Persons with access to the Internet                                                                                   information will be collected three
                                                                                                            Comments are invited on: (a) Whether
                                          may obtain the document at either                                                                                       months prior to the completion of
                                                                                                         the proposed collection of information
                                          http://www.fda.gov/cder/guidance/                              is necessary for the proper performance                  obligated service: (1) Verification of
                                          index.htm or http://www.fda.gov/                               of the functions of the agency, including                current contact information; (2) if
                                          ohrms/dockets/default.htm.                                     whether the information shall have                       employment is to be continued at the
                                            Dated: February 28, 2007.                                    practical utility; (b) the accuracy of the               same NHSC site; (3) if the clinician
                                                                                                         agency’s estimate of the burden of the                   moved from the NHSC service site but
                                          Jeffrey Shuren,
                                                                                                         proposed collection of information; (c)                  plans to continue practicing in an
                                          Assistant Commissioner for Policy.                                                                                      underserved area, and (4) the primary
                                                                                                         ways to enhance the quality, utility, and
                                          [FR Doc. 07–1048 Filed 2–2–07; 10:22 am]                                                                                reason for stopping practice in an
                                                                                                         clarity of the information to be
                                          BILLING CODE 4160–01–S                                         collected; and (d) ways to minimize the                  underserved area, if applicable.
                                                                                                         burden of the collection of information                    The estimated burden is as follows:

                                                                                                                                                                 Responses
                                                                                                                                                Number of                           Hours per   Total burden
                                                                                 Type of report                                                                      per
                                                                                                                                               respondents                          response       hours
                                                                                                                                                                 respondent

                                          NHSC Clinical Retention Information ..............................................................         1000             1               0.25          250



                                            Send comments to Susan G. Queen,                             DEPARTMENT OF HEALTH AND                                 Reduction Act of 1995. To request more
                                          PhD, HRSA Reports Clearance Officer,                           HUMAN SERVICES                                           information on the proposed project or
                                          Room 10–33, Parklawn Building, 5600                                                                                     to obtain a copy of the data collection
                                          Fishers Lane, Rockville, MD 20857.                             Health Resources and Services                            plans and draft instruments, call the
                                          Written comments should be received                            Administration                                           HRSA Reports Clearance Officer on
                                          within 60 days of this notice.                                                                                          (301) 443–1129.
                                                                                                         Agency Information Collection                               Comments are invited on: (a) Whether
                                            Dated: February 27, 2007.                                    Activities: Proposed Collection:                         the proposed collection of information
                                          Alexandra Huttinger,                                           Comment Request                                          is necessary for the proper performance
                                          Acting Director, Division of Policy Review                                                                              of the functions of the agency, including
                                          and Coordination.                                                In compliance with the requirement                     whether the information shall have
                                          [FR Doc. E7–3901 Filed 3–6–07; 8:45 am]                        for opportunity for public comment on                    practical utility; (b) the accuracy of the
                                          BILLING CODE 4165–15–P
                                                                                                         proposed data collection projects                        agency’s estimate of the burden of the
                                                                                                         (section 3506(c)(2)(A) of Title 44, United               proposed collection of information; (c)
                                                                                                         States Code, as amended by the                           ways to enhance the quality, utility, and
                                                                                                         Paperwork Reduction Act of 1995, Pub.                    clarity of the information to be
                                                                                                         L. 104–13), the Health Resources and                     collected; and (d) ways to minimize the
sroberts on PROD1PC70 with NOTICES




                                                                                                         Services Administration (HRSA)                           burden of the collection of information
                                                                                                         publishes periodic summaries of                          on respondents, including through the
                                                                                                         proposed projects being developed for                    use of automated collection techniques
                                                                                                         submission to the Office of Management                   or other forms of information
                                                                                                         and Budget (OMB) under the Paperwork                     technology.


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