Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting, 57195-57196 [2015-23641]
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57195
Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Notices
be submitted to CBER if continued
evaluation is deemed necessary.
Section 660.36(a) requires, after each
routine establishment inspection by
FDA, the submission of samples from a
lot of final Reagent Red Blood Cell
product along with a protocol
containing specific information. Section
660.36(a)(2) requires that a protocol
contain information including, but not
limited to, manufacturing records,
certain test records, and identity test
results. Section 660.36(b) requires a
copy of the antigenic constitution
matrix specifying the antigens present
or absent to be submitted to the CBER
Director at the time of initial
distribution of each lot.
Section 660.46(a) contains
requirements as to the frequency of
submission of samples from each lot of
Hepatitis B Surface Antigen product,
and § 660.46(b) contains the
requirements as to the submission of a
protocol containing specific information
along with each required sample. For
§ 660.46 products subject to official
release by FDA, one sample from each
filling of each lot is required to be
submitted along with a protocol
consisting of a summary of the history
of manufacture of the product,
including all results of each test for
which test results are requested by
CBER. After notification of official
release is received, one sample along
with a protocol is required to be
submitted at 90-day intervals. In
addition, samples, which must be
accompanied by a protocol, may at any
time be required to be submitted to
CBER if continued evaluation is deemed
necessary.
Samples and protocols are required by
FDA to help ensure the safety, purity, or
potency of a product because of the
potential lot-to-lot variability of a
product produced from living
organisms. In cases of certain biological
products (e.g., Albumin, Plasma Protein
Fraction, and therapeutic biological
products) that are known to have lot-tolot consistency, official lot release is not
normally required. However,
submissions of samples and protocols of
these products may still be required for
surveillance, licensing, and export
purposes, or in the event that FDA
obtains information that the
manufacturing process may not result in
consistent quality of the product.
The following burden estimate is for
the protocols required to be submitted
with each sample. The collection of
samples is not a collection of
information under 5 CFR 1320.3(h)(2).
Respondents to the collection of
information under § 610.2 are
manufacturers of licensed biological
products. Respondents to the collection
of information under §§ 660.6(b),
660.36(a)(2) and (b), and 660.46(b) are
manufacturers of the specific products
referenced previously in this document.
The estimated number of respondents
for each regulation is based on the
annual number of manufacturers that
submitted samples and protocols for
biological products including
submissions for lot release, surveillance,
licensing, or export. Based on
information obtained from FDA’s
database system, approximately 80
manufacturers submitted samples and
protocols in fiscal year (FY) 2014, under
the regulations cited previously in this
document. FDA estimates that
approximately 76 manufacturers
submitted protocols under § 610.2 and 2
manufacturers submitted protocols
under the regulation (§ 660.6) for the
other specific product. FDA received no
submissions under § 660.36 or § 660.46,
however FDA is using the estimate of
one protocol submission under each
regulation in the event that protocols are
submitted in the future.
In the Federal Register of March 27,
2015 (80 FR 16393), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
The estimated total annual responses
are based on FDA’s final actions
completed in FY 2014 for the various
submission requirements of samples
and protocols for the licensed biological
products. The average burden per
response is based on information
provided by industry. The burden
estimates provided by industry ranged
from 1 to 5.5 hours. Under § 610.2, the
average burden per response is based on
the average of these estimates and
rounded to 3 hours. Under the
remaining regulations, the average
burden per response is based on the
higher end of the estimate (rounded to
5 or 6 hours) since more information is
generally required to be submitted in
the other protocols than under § 610.2.
FDA estimates the burden of this
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR Section
Total annual
responses
Average
burden per
response
Total hours
610.2 Lot Release Information Submission .......................
660.6(b) Lot Release Information Submission ..................
660.36(a)(2) and (b) Lot Release Information Submission
660.46(b) Lot Release Information Submission ................
76
2
1
1
84.54
9
1
1
6,197
18
1
1
3
5
6
5
18,591
90
6
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.
Leslie Kux,
Associate Commissioner for Policy.
tkelley on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2015–24028 Filed 9–21–15; 8:45 am]
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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
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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
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57196
Federal Register / Vol. 80, No. 183 / Tuesday, September 22, 2015 / Notices
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,
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: September 16, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–23641 Filed 9–21–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meetings
tkelley on DSK3SPTVN1PROD with NOTICES
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 meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
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 on
Aging Special Emphasis Panel;
Cerebrovascular Disease and Aging II.
Date: October 22, 2015.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute On Aging,
Gateway Building, Suite 2C212, 7201
VerDate Sep<11>2014
17:39 Sep 21, 2015
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Wisconsin Ave., Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Ramesh Vemuri, Ph.D.,
Chief, Scientific Review Branch, National
Institute On Aging, National Institutes Of
Health, 7201 Wisconsin Avenue, Suite 2C–
212, Bethesda, MD 20892, 301–402–7700,
rv23r@nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Lifespan
Connectome.
Date: November 9, 2015.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2c212, 7201
Wisconsin Avenue, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Alexander Parsadanian,
Ph.D., Scientific Review Officer, National
Institute On Aging, Gateway Building 2C/
212, 7201 Wisconsin Avenue, Bethesda, MD
20892, 301–496–9666, PARSADANIANA@
NIA.NIH.GOV.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Biomarkers
For AD: The Adult Children Study.
Date: November 12, 2015.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute On Aging,
Gateway Building, Suite 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Alexander Parsadanian,
Ph.D., Scientific Review Officer, National
Institute On Aging, Gateway Building 2C/
212, 7201 Wisconsin Avenue, Bethesda, MD
20892, 301–496–9666, PARSADANIANA@
NIA.NIH.GOV.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Vascular
Contribution to AD and Genetic Risk Factors.
Date: November 16, 2015.
Time: 12:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, Suite 2C212, 7201
Wisconsin Avenue, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Alexander Parsadanian,
Ph.D., Scientific Review Officer, National
Institute On Aging, Gateway Building 2C/
212, 7201 Wisconsin Avenue, Bethesda, MD
20892, 301–496–9666, PARSADANIANA@
NIA.NIH.GOV.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: September 17, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–24035 Filed 9–21–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Nursing Research;
Notice of Closed Meetings
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 meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
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
Nursing Research Initial Review Group.
Date: October 19–20, 2015.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Weiqun Li, MD, Scientific
Review Officer, National Institute of Nursing
Research, National Institutes of Health, 6701
Democracy Blvd. Ste. 710, Bethesda, MD
20892 (301) 594–5966 wli@mail.nih.gov.
Name of Committee: National Institute of
Nursing Research Special Emphasis Panel;
Institutional Training Grants
Date: October 20,2015.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications,
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Weiqun Li, MD, Scientific
Review Administrator National Institute of
Nursing Research National Institutes of
Health, 6701 Democracy Blvd. Ste. 710,
Bethesda, MD 20892 (301) 594–5966 wli@
mail.nih.gov.
Name of Committee: National Institute of
Nursing Research Special Emphasis Panel;
Community Partnerships to Advance
Research.
Date: October 21, 2015.
Time: 11:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 703, 6701 Democracy
Boulevard Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Tamizchelvi Thyagarajan,
Ph.D. Scientific Review Officer, National
Institute of Nursing Research, National
Institutes of Health, Bethesda, MD 20892
(301) 594–0343 tamizchelvi.thyagarajan@
nih.gov.
Name of Committee: National Institute of
Nursing Research Special Emphasis Panel;
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]]>Agencies
[Federal Register Volume 80, Number 183 (Tuesday, September 22, 2015)]
[Notices]
[Pages 57195-57196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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,
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: 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
