80_FR_57378 80 FR 57195 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting

80 FR 57195 - 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 183 (September 22, 2015)

Page Range57195-57196
FR Document2015-23641

Federal Register, Volume 80 Issue 183 (Tuesday, September 22, 2015) 
[Federal Register Volume 80, Number 183 (Tuesday, September 22, 2015)]
[Notices]
[Pages 57195-57196]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-23641]


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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

[[Page 57196]]

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 Initial Review Group Developmental Biology Subcommittee.
    Date: November 12, 2015.
    Time: 8:00 p.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 
Wisconsin Avenue, Bethesda, MD 20814.
    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, Bethesda, MD 20892-9304, (301) 435-6878, 
[email protected].

(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: September 16, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-23641 Filed 9-21-15; 8:45 am]
BILLING CODE 4140-01-P

Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Notices 57195 be submitted to CBER if continued CBER if continued evaluation is deemed manufacturers submitted samples and evaluation is deemed necessary. necessary. protocols in fiscal year (FY) 2014, under Section 660.36(a) requires, after each Samples and protocols are required by the regulations cited previously in this routine establishment inspection by FDA to help ensure the safety, purity, or document. FDA estimates that FDA, the submission of samples from a potency of a product because of the approximately 76 manufacturers lot of final Reagent Red Blood Cell potential lot-to-lot variability of a submitted protocols under § 610.2 and 2 product along with a protocol product produced from living manufacturers submitted protocols containing specific information. Section organisms. In cases of certain biological under the regulation (§ 660.6) for the 660.36(a)(2) requires that a protocol products (e.g., Albumin, Plasma Protein other specific product. FDA received no contain information including, but not Fraction, and therapeutic biological submissions under § 660.36 or § 660.46, limited to, manufacturing records, products) that are known to have lot-to- however FDA is using the estimate of certain test records, and identity test lot consistency, official lot release is not one protocol submission under each results. Section 660.36(b) requires a normally required. However, regulation in the event that protocols are copy of the antigenic constitution submissions of samples and protocols of submitted in the future. matrix specifying the antigens present these products may still be required for In the Federal Register of March 27, surveillance, licensing, and export 2015 (80 FR 16393), FDA published a or absent to be submitted to the CBER purposes, or in the event that FDA Director at the time of initial 60-day notice requesting public obtains information that the distribution of each lot. comment on the proposed collection of manufacturing process may not result in Section 660.46(a) contains information. No comments were consistent quality of the product. requirements as to the frequency of The following burden estimate is for received. submission of samples from each lot of the protocols required to be submitted The estimated total annual responses Hepatitis B Surface Antigen product, with each sample. The collection of are based on FDA’s final actions and § 660.46(b) contains the samples is not a collection of completed in FY 2014 for the various requirements as to the submission of a information under 5 CFR 1320.3(h)(2). submission requirements of samples protocol containing specific information Respondents to the collection of and protocols for the licensed biological along with each required sample. For information under § 610.2 are products. The average burden per § 660.46 products subject to official manufacturers of licensed biological response is based on information release by FDA, one sample from each products. Respondents to the collection provided by industry. The burden filling of each lot is required to be of information under §§ 660.6(b), estimates provided by industry ranged submitted along with a protocol 660.36(a)(2) and (b), and 660.46(b) are from 1 to 5.5 hours. Under § 610.2, the consisting of a summary of the history manufacturers of the specific products average burden per response is based on of manufacture of the product, referenced previously in this document. the average of these estimates and including all results of each test for The estimated number of respondents rounded to 3 hours. Under the which test results are requested by for each regulation is based on the remaining regulations, the average CBER. After notification of official annual number of manufacturers that burden per response is based on the release is received, one sample along submitted samples and protocols for higher end of the estimate (rounded to with a protocol is required to be biological products including 5 or 6 hours) since more information is submitted at 90-day intervals. In submissions for lot release, surveillance, generally required to be submitted in addition, samples, which must be licensing, or export. Based on the other protocols than under § 610.2. accompanied by a protocol, may at any information obtained from FDA’s FDA estimates the burden of this time be required to be submitted to database system, approximately 80 information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual 21 CFR Section responses per burden per Total hours respondents responses respondent response 610.2 Lot Release Information Submission ....................... 76 84.54 6,197 3 18,591 660.6(b) Lot Release Information Submission .................. 2 9 18 5 90 660.36(a)(2) and (b) Lot Release Information Submission 1 1 1 6 6 660.46(b) Lot Release Information Submission ................ 1 1 1 5 5 Total ............................................................................ 80 .......................... 6,217 ........................ 18,692 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: September 16, 2015. DEPARTMENT OF HEALTH AND amended (5 U.S.C. App.), notice is Leslie Kux, HUMAN SERVICES hereby given of the following meeting. Associate Commissioner for Policy. The meeting will be closed to the [FR Doc. 2015–24028 Filed 9–21–15; 8:45 am] National Institutes of Health public in accordance with the provisions set forth in section 552b(c)(4) BILLING CODE 4164–01–P tkelley on DSK3SPTVN1PROD with NOTICES Eunice Kennedy Shriver National and 552b(c)(6), Title 5 U.S.C., as Institute of Child Health and Human amended. The grant applications and Development; Notice of Closed the discussions could disclose Meeting confidential trade secrets or commercial property such as patentable material, Pursuant to section 10(d) of the and personal information concerning Federal Advisory Committee Act, as individuals associated with the grant VerDate Sep<11>2014 17:39 Sep 21, 2015 Jkt 235001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\22SEN1.SGM 22SEN1

57196 Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Notices applications, the disclosure of which Wisconsin Ave., Bethesda, MD 20892, DEPARTMENT OF HEALTH AND would constitute a clearly unwarranted (Telephone Conference Call). HUMAN SERVICES invasion of personal privacy. Contact Person: Ramesh Vemuri, Ph.D., Chief, Scientific Review Branch, National National Institutes of Health Name of Committee: National Institute of Child Health and Human Development Initial Institute On Aging, National Institutes Of Review Group Developmental Biology Health, 7201 Wisconsin Avenue, Suite 2C– National Institute of Nursing Research; Subcommittee. 212, Bethesda, MD 20892, 301–402–7700, Notice of Closed Meetings Date: November 12, 2015. rv23r@nih.gov. Pursuant to section 10(d) of the Time: 8:00 p.m. to 6:00 p.m. Name of Committee: National Institute on Agenda: To review and evaluate grant Federal Advisory Committee Act, as Aging Special Emphasis Panel; Lifespan amended (5 U.S.C. App.), notice is applications. Connectome. Place: Hyatt Regency Bethesda, One hereby given of the following meetings. Date: November 9, 2015. The meetings will be closed to the Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Time: 1:00 p.m. to 3:00 p.m. public in accordance with the Contact Person: Cathy J. Wedeen, Ph.D., Agenda: To review and evaluate grant provisions set forth in sections Scientific Review Officer, Scientific Review applications. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Branch, Eunice Kennedy Shriver National Place: National Institute on Aging, as amended. The grant applications and Institute of Child Health and Human Gateway Building, Suite 2c212, 7201 the discussions could disclose Development, NIH, 6100 Executive Wisconsin Avenue, Bethesda, MD 20892, Boulevard, Room 5B01, Bethesda, MD confidential trade secrets or commercial (Telephone Conference Call). property such as patentable material, 20892–9304, (301) 435–6878, Contact Person: Alexander Parsadanian, wedeenc@mail.nih.gov. and personal information concerning Ph.D., Scientific Review Officer, National individuals associated with the grant (Catalogue of Federal Domestic Assistance Institute On Aging, Gateway Building 2C/ Program Nos. 93.864, Population Research; applications, the disclosure of which 212, 7201 Wisconsin Avenue, Bethesda, MD 93.865, Research for Mothers and Children; would constitute a clearly unwarranted 20892, 301–496–9666, PARSADANIANA@ 93.929, Center for Medical Rehabilitation invasion of personal privacy. NIA.NIH.GOV. Research; 93.209, Contraception and Name of Committee: National Institute of Infertility Loan Repayment Program, National Name of Committee: National Institute on Nursing Research Initial Review Group. Institutes of Health, HHS) Aging Special Emphasis Panel; Biomarkers Date: October 19–20, 2015. For AD: The Adult Children Study. Time: 8:00 a.m. to 12:00 p.m. Dated: September 16, 2015. Date: November 12, 2015. Agenda: To review and evaluate grant Michelle Trout, Time: 12:00 p.m. to 4:00 p.m. applications. Program Analyst, Office of Federal Advisory Agenda: To review and evaluate grant Place: Bethesda Marriott Suites, 6711 Committee Policy. applications. Democracy Boulevard, Bethesda, MD 20817. [FR Doc. 2015–23641 Filed 9–21–15; 8:45 am] Place: National Institute On Aging, Contact Person: Weiqun Li, MD, Scientific Gateway Building, Suite 2C212, 7201 Review Officer, National Institute of Nursing BILLING CODE 4140–01–P Wisconsin Avenue, Bethesda, MD 20892, Research, National Institutes of Health, 6701 Democracy Blvd. Ste. 710, Bethesda, MD (Telephone Conference Call). 20892 (301) 594–5966 wli@mail.nih.gov. DEPARTMENT OF HEALTH AND Contact Person: Alexander Parsadanian, Ph.D., Scientific Review Officer, National Name of Committee: National Institute of HUMAN SERVICES Nursing Research Special Emphasis Panel; Institute On Aging, Gateway Building 2C/ Institutional Training Grants National Institutes of Health 212, 7201 Wisconsin Avenue, Bethesda, MD Date: October 20,2015. 20892, 301–496–9666, PARSADANIANA@ Time: 12:00 p.m. to 6:00 p.m. National Institute on Aging; Notice of NIA.NIH.GOV. Agenda: To review and evaluate grant Closed Meetings Name of Committee: National Institute on applications, Pursuant to section 10(d) of the Aging Special Emphasis Panel; Vascular Place: Bethesda Marriott Suites, 6711 Contribution to AD and Genetic Risk Factors. Democracy Boulevard, Bethesda, MD 20817. Federal Advisory Committee Act, as Date: November 16, 2015. Contact Person: Weiqun Li, MD, Scientific amended (5 U.S.C. App.), notice is Review Administrator National Institute of hereby given of the following meetings. Time: 12:00 p.m. to 3:30 p.m. Nursing Research National Institutes of The meetings will be closed to the Agenda: To review and evaluate grant Health, 6701 Democracy Blvd. Ste. 710, public in accordance with the applications. Bethesda, MD 20892 (301) 594–5966 wli@ provisions set forth in sections Place: National Institute on Aging, mail.nih.gov. 552b(c)(4) and 552b(c)(6), title 5 U.S.C., Gateway Building, Suite 2C212, 7201 Name of Committee: National Institute of as amended. The grant applications and Wisconsin Avenue, Bethesda, MD 20892, Nursing Research Special Emphasis Panel; the discussions could disclose (Telephone Conference Call). Community Partnerships to Advance confidential trade secrets or commercial Contact Person: Alexander Parsadanian, Research. Ph.D., Scientific Review Officer, National Date: October 21, 2015. property such as patentable material, Institute On Aging, Gateway Building 2C/ Time: 11:00 a.m. to 1:00 p.m. and personal information concerning 212, 7201 Wisconsin Avenue, Bethesda, MD Agenda: To review and evaluate grant individuals associated with the grant 20892, 301–496–9666, PARSADANIANA@ applications. applications, the disclosure of which Place: National Institutes of Health, One NIA.NIH.GOV. would constitute a clearly unwarranted Democracy Plaza, 703, 6701 Democracy invasion of personal privacy. (Catalogue of Federal Domestic Assistance Boulevard Bethesda, MD 20892, (Telephone Program Nos. 93.866, Aging Research, Name of Committee: National Institute on Conference Call). National Institutes of Health, HHS) Contact Person: Tamizchelvi Thyagarajan, Aging Special Emphasis Panel; tkelley on DSK3SPTVN1PROD with NOTICES Cerebrovascular Disease and Aging II. Dated: September 17, 2015. Ph.D. Scientific Review Officer, National Date: October 22, 2015. Melanie J. Gray, Institute of Nursing Research, National Time: 1:00 p.m. to 4:00 p.m. Institutes of Health, Bethesda, MD 20892 Program Analyst, Office of Federal Advisory (301) 594–0343 tamizchelvi.thyagarajan@ Agenda: To review and evaluate grant Committee Policy. nih.gov. applications. Place: National Institute On Aging, [FR Doc. 2015–24035 Filed 9–21–15; 8:45 am] Name of Committee: National Institute of Gateway Building, Suite 2C212, 7201 BILLING CODE 4140–01–P Nursing Research Special Emphasis Panel; VerDate Sep<11>2014 17:39 Sep 21, 2015 Jkt 235001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\22SEN1.SGM 22SEN1


Document Created: 2015-12-15 09:35:38
Document Modified: 2015-12-15 09:35:38
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
DatesNovember 12, 2015.
FR Citation80 FR 57195 
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