80_FR_13431 80 FR 13382 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting

80 FR 13382 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 49 (March 13, 2015)

Page Range13382-13382
FR Document2015-05706

Federal Register, Volume 80 Issue 49 (Friday, March 13, 2015)
[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Notices]
[Page 13382]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-05706]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Eunice Kennedy Shriver National Institute of Child Health and 
Human Development; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of the following 
meeting.
    The meeting will be closed to the public in accordance with the 
provisions set forth in section 552b(c)(4) and 552b(c)(6), Title 5 
U.S.C., as amended. The grant applications and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the grant applications, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Child Health and Human 
Development Special Emphasis Panel; Wellstone Centers for Muscular 
Dystrophy.
    Date: April 27-28, 2015.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Embassy Suite at the Chevy Chase Pavilion, Washington, DC 
20115.
    Contact Person: Cathy J. Wedeen, Ph.D., Scientific Review 
Officer, Scientific Review Branch, Eunice Kennedy Shriver National 
Institute of Child Health and Human Development, NIH, 6100 Executive 
Boulevard, Room 5B01-G, Bethesda, MD 20892-9304, (301) 435-6878, 
wedeenc@mail.nih.gov.

(Catalogue of Federal Domestic Assistance Program Nos. 93.864, 
Population Research; 93.865, Research for Mothers and Children; 
93.929, Center for Medical Rehabilitation Research; 93.209, 
Contraception and Infertility Loan Repayment Program, National 
Institutes of Health, HHS)

    Dated: March 9, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-05706 Filed 3-12-15; 8:45 am]
BILLING CODE 4140-01-P



                                                  13382                           Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Notices

                                                  alternative regulatory approaches, we                   DEPARTMENT OF HEALTH AND                              DEPARTMENT OF HEALTH AND
                                                  selected those approaches that would                    HUMAN SERVICES                                        HUMAN SERVICES
                                                  maximize net benefits. Based on the
                                                  analysis that follows, the Department                   National Institutes of Health                         Food and Drug Administration
                                                  believes that these proposed priorities                                                                       [Docket No. FDA–2015–D–0198]
                                                  are consistent with the principles in                   Eunice Kennedy Shriver National
                                                  Executive Order 13563.                                  Institute of Child Health and Human                   Current Good Manufacturing Practice
                                                     We also have determined that this                    Development; Notice of Closed                         Requirements for Combination
                                                  regulatory action would not unduly                      Meeting                                               Products; Draft Guidance for Industry
                                                  interfere with State, local, and tribal                                                                       and Food and Drug Administration
                                                  governments in the exercise of their                      Pursuant to section 10(d) of the                    Staff; Extension of Comment Period
                                                  governmental functions.                                 Federal Advisory Committee Act, as
                                                                                                          amended (5 U.S.C. App.), notice is                    AGENCY:   Food and Drug Administration,
                                                     In accordance with both Executive                                                                          HHS.
                                                  Orders, the Department has assessed the                 hereby given of the following meeting.
                                                                                                                                                                ACTION:   Notice; extension of comment
                                                  potential costs and benefits, both                        The meeting will be closed to the
                                                                                                                                                                period.
                                                  quantitative and qualitative, of this                   public in accordance with the
                                                  regulatory action. The potential costs                  provisions set forth in section 552b(c)(4)            SUMMARY:    The Food and Drug
                                                  are those resulting from statutory                      and 552b(c)(6), Title 5 U.S.C., as                    Administration (FDA) is extending the
                                                  requirements and those we have                          amended. The grant applications and                   comment period by 30 days to April 29,
                                                  determined as necessary for                             the discussions could disclose                        2015, for the notice entitled ‘‘Current
                                                  administering the Department’s                          confidential trade secrets or commercial              Good Manufacturing Practice
                                                  programs and activities.                                property such as patentable material,                 Requirements for Combination
                                                     The benefits of the Disability and                   and personal information concerning                   Products; Draft Guidance for Industry
                                                  Rehabilitation Research Projects and                    individuals associated with the grant                 and Food and Drug Administration
                                                  Centers Program have been well                          applications, the disclosure of which                 Staff; Availability,’’ that appeared in the
                                                  established over the years. Projects                    would constitute a clearly unwarranted                Federal Register of January 27, 2015 (80
                                                  similar to ones envisioned by the                       invasion of personal privacy.                         FR 4280). In that document, FDA
                                                  proposed priorities have been                                                                                 announced the availability of a draft
                                                                                                            Name of Committee: National Institute of            guidance for industry and FDA staff and
                                                  completed successfully, and the
                                                                                                          Child Health and Human Development
                                                  proposed priorities would generate new                                                                        requested comments. The Agency is
                                                                                                          Special Emphasis Panel; Wellstone Centers
                                                  knowledge through research. The new                                                                           taking this action in response to a
                                                                                                          for Muscular Dystrophy.
                                                  DRRPs would generate, disseminate,                                                                            request for an extension to allow
                                                                                                            Date: April 27–28, 2015.
                                                  and promote the use of new information                                                                        interested persons additional time to
                                                                                                            Time: 8:00 a.m. to 5:00 p.m.
                                                  that would improve outcomes for                                                                               submit comments.
                                                                                                            Agenda: To review and evaluate grant
                                                  individuals with disabilities.                          applications.                                         DATES: FDA is extending the comment
                                                     Intergovernmental Review: This                         Place: Embassy Suite at the Chevy Chase             period on the draft guidance. Submit
                                                  program is not subject to Executive                     Pavilion, Washington, DC 20115.                       either electronic or written comments
                                                  Order 12372.                                              Contact Person: Cathy J. Wedeen, Ph.D.,             by April 29, 2015.
                                                     Electronic Access to This Document:                  Scientific Review Officer, Scientific Review          ADDRESSES: Submit written requests for
                                                  The official version of this document is                Branch, Eunice Kennedy Shriver National               single copies of the draft guidance
                                                  the document published in the Federal                   Institute of Child Health and Human                   document entitled ‘‘Current Good
                                                  Register. Free Internet access to the                   Development, NIH, 6100 Executive                      Manufacturing Practice Requirements
                                                  official edition of the Federal Register                Boulevard, Room 5B01–G, Bethesda, MD                  for Combination Products’’ to the Office
                                                  and the Code of Federal Regulations is                  20892–9304, (301) 435–6878, wedeenc@mail              of Combination Products, Food and
                                                  available via the Federal Digital System                .nih.gov.                                             Drug Administration, 10903 New
                                                  at: www.gpo.gov/fdsys. At this site you                 (Catalogue of Federal Domestic Assistance             Hampshire Ave., Bldg. 32, Rm. 5129,
                                                  can view this document, as well as all                  Program Nos. 93.864, Population Research;             Silver Spring, MD 20993–0002. Send
                                                  other documents of this Department                      93.865, Research for Mothers and Children;            one self-addressed adhesive label to
                                                  published in the Federal Register, in                   93.929, Center for Medical Rehabilitation             assist that office in processing your
                                                  text or Adobe Portable Document                         Research; 93.209, Contraception and                   request. See the SUPPLEMENTARY
                                                  Format (PDF). To use PDF you must                       Infertility Loan Repayment Program, National          INFORMATION section for electronic
                                                  have Adobe Acrobat Reader, which is                     Institutes of Health, HHS)                            access to the draft guidance document.
                                                  available free at the site.                               Dated: March 9, 2015.                                 Submit electronic comments on the
                                                                                                                                                                draft guidance to http://www.
                                                     You may also access documents of the                 Michelle Trout,
                                                                                                                                                                regulations.gov. Submit written
                                                  Department published in the Federal                     Program Analyst, Office of Federal Advisory           comments to the Division of Dockets
                                                  Register by using the article search                    Committee Policy.                                     Management (HFA–305), Food and Drug
                                                  feature at: www.federalregister.gov.                    [FR Doc. 2015–05706 Filed 3–12–15; 8:45 am]           Administration, 5630 Fishers Lane, Rm.
                                                  Specifically, through the advanced                      BILLING CODE 4140–01–P                                1061, Rockville, MD 20852. Identify
                                                  search feature at this site, you can limit
                                                                                                                                                                comments with the docket number
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                  your search to documents published by
                                                                                                                                                                found in brackets in the heading of this
                                                  the Department.
                                                                                                                                                                document.
                                                    Dated: March 3, 2015.
                                                                                                                                                                FOR FURTHER INFORMATION CONTACT: John
                                                  Kathy Greenlee,                                                                                               Barlow Weiner, Office of Combination
                                                  Administrator.                                                                                                Products, Food and Drug
                                                  [FR Doc. 2015–05333 Filed 3–12–15; 8:45 am]                                                                   Administration, 10903 New Hampshire
                                                  BILLING CODE 4154–01–P                                                                                        Ave., Bldg. 32, Rm. 5129, Silver Spring,


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Document Created: 2015-12-18 11:41:38
Document Modified: 2015-12-18 11:41:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesApril 27-28, 2015.
FR Citation80 FR 13382 

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