National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 15596 [2014-06135]
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15596
Federal Register / Vol. 79, No. 54 / Thursday, March 20, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
10.30
10.33
10.35
10.85
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
....................................................................................
....................................................................................
....................................................................................
....................................................................................
207
4
5
4
1
1
1
1
207
4
5
4
24
10
10
16
4,968
40
50
64
Total ..............................................................................
........................
........................
........................
........................
5,122
ehiers on DSK2VPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimates for this
collection of information are based on
Agency records.
On December 19, 2013, FDA
published a technical amendment (78
FR 76748) announcing that the Agency
is modernizing its administrative
regulations regarding submission of
citizen petitions to explicitly provide for
electronic submission. The current
regulation does not recognize electronic
methods for submitting citizen
petitions; thus, this action will enable
efficiency and ease in the filing of
citizen petitions.
The Agency still allows for nonelectronic submissions, however,
electronic submissions of a citizen
petition to a specific electronic docket
presents a simpler and straightforward
approach. FDA has created a single
docket on https://www.regulations.gov,
the U.S. Government’s consolidated
docket Web site for Federal Agencies,
for the initial electronic submission of
all citizen petitions. The FDA Electronic
Method for Submission of Citizen
Petitions Docket, Docket No. FDA 2013–
S–0610, allows the petitioner to create
an electronic submission through https://
www.regulations.gov and provides an
alternative to the current system of
submission for citizen petitions.
Electronic submissions through
https://www.regulations.gov will provide
the submitter with an immediate record
of the time of submission. FDA’s
Division of Dockets Management (DDM)
(https://www.fda.gov/
RegulatoryInformation/Dockets/
default.htm) will continue to inform the
submitter of formal filing; however,
tracking will be more easily
accomplished through electronic
submission.
DDM will receive the electronically
submitted citizen petition through the
Federal Dockets Management System,
the Agency component of https://
www.regulations.gov. Subsequently,
DDM will review the electronic
submission and when it accepts the
citizen petition for filing, DDM will
assign a docket number to that petition,
VerDate Mar<15>2010
14:48 Mar 19, 2014
Jkt 232001
different from the FDA electronic
submission docket number. This unique
docket number from DDM identifies the
docket for that particular citizen
petition for all future filings and
submissions related only to that citizen
petition. Subsequent submissions
associated with that citizen petition will
refer to the assigned unique docket
number. The advantage to this change is
that it ensures efficiency and ease in
communication, quicker interaction
between citizen petitioners and FDA,
and easier access to FDA to seek input
through the citizen petition process.
Dated: March 14, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–06132 Filed 3–19–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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 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
Allergy and Infectious Diseases Special
Emphasis Panel; Functional Glycomics in
HIV Vaccine Design.
Date: April 10, 2014 (Subset A).
Time: 1:00 p.m. to 5:00 p.m.
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Room
3265, 6700B Rockledge Drive, Bethesda, MD
20817 (Telephone Conference Call).
Contact Person: Kelly Y. Poe, Ph.D.,
Scientific Review Officer, Scientific Review
Program, DEA/NIAID/NIH/DHHS, 6700–B
Rockledge Drive, MDS–7616, Bethesda, MD
20892, 301–451–2639, poeky@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Functional Glycomics in
HIV Vaccine Design.
Date: April 17, 2014 (Subset B).
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Room
3265, 6700B Rockledge Drive, Bethesda, MD
20817 (Telephone Conference Call).
Contact Person: Kelly Y. Poe, Ph.D.,
Scientific Review Officer, Scientific Review
Program, DEA/NIAID/NIH/DHHS, 6700–B
Rockledge Drive, MDS–7616, Bethesda, MD
20892, 301–451–2639, poeky@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: March 14, 2014.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–06135 Filed 3–19–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & 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 sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
E:\FR\FM\20MRN1.SGM
20MRN1
Agencies
[Federal Register Volume 79, Number 54 (Thursday, March 20, 2014)]
[Notices]
[Page 15596]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06135]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; 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 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 Allergy and Infectious
Diseases Special Emphasis Panel; Functional Glycomics in HIV Vaccine
Design.
Date: April 10, 2014 (Subset A).
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Room 3265, 6700B Rockledge
Drive, Bethesda, MD 20817 (Telephone Conference Call).
Contact Person: Kelly Y. Poe, Ph.D., Scientific Review Officer,
Scientific Review Program, DEA/NIAID/NIH/DHHS, 6700-B Rockledge
Drive, MDS-7616, Bethesda, MD 20892, 301-451-2639,
poeky@niaid.nih.gov.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel; Functional Glycomics in HIV Vaccine
Design.
Date: April 17, 2014 (Subset B).
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Room 3265, 6700B Rockledge
Drive, Bethesda, MD 20817 (Telephone Conference Call).
Contact Person: Kelly Y. Poe, Ph.D., Scientific Review Officer,
Scientific Review Program, DEA/NIAID/NIH/DHHS, 6700-B Rockledge
Drive, MDS-7616, Bethesda, MD 20892, 301-451-2639,
poeky@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: March 14, 2014.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-06135 Filed 3-19-14; 8:45 am]
BILLING CODE 4140-01-P