Agency Information Collection Activities; Proposed Collection; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions, 55396-55397 [2011-22857]
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55396
Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Notices
The number of respondents in tables
1 and 2 of this document are an average
from data for the previous 3 years, i.e.,
fiscal years 2008 to 2010. The number
of annual reports submitted under
§ 814.126(b)(1) in table 1 reflects 43
respondents with approved HUD
applications. Likewise, under
§ 814.126(b)(2) in table 2, the number of
recordkeepers is 43.
Dated: September 1, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2011–22858 Filed 9–6–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0627]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; General
Administrative Procedures: Citizen
Petitions; Petition for Reconsideration
or Stay of Action; Advisory Opinions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the reporting requirements contained in
existing FDA regulations regarding the
general administrative procedures for a
person to petition the Commissioner of
Food and Drugs (the Commissioner) to
issue, amend, or revoke a rule; to file a
petition for an administrative
reconsideration or an administrative
stay of action; and to request an
advisory opinion from the
Commissioner.
DATES: Submit either electronic or
written comments on the collection of
information by November 7, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
emcdonald on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:37 Sep 06, 2011
Jkt 223001
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
General Administrative Procedures:
Citizen Petitions; Petition for
Reconsideration or Stay of Action;
Advisory Opinions—(OMB Control
Number 0910–0183)—Extension
The Administrative Procedures Act (5
U.S.C. 553(e)), provides that every
Agency shall give an interested person
the right to petition for issuance,
amendment, or repeal of a rule. Section
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
10.30 (21 CFR 10.30) sets forth the
format and procedures by which an
interested person may submit to FDA, in
accordance with § 10.20 (21 CFR 10.20)
(submission of documents to Division of
Dockets Management), a citizen petition
requesting the Commissioner to issue,
amend, or revoke a regulation or order,
or to take or refrain from taking any
other form of administrative action.
The Commissioner may grant or deny
such a petition, in whole or in part, and
may grant such other relief or take other
action as the petition warrants.
Respondents are individuals or
households, State or local governments,
not-for-profit institutions or groups.
Section 10.33 (21 CFR 10.33) issued
under section 701(a) of the Federal,
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 371(a)), sets forth
the format and procedures by which an
interested person may request
reconsideration of part or all of a
decision of the Commissioner on a
petition submitted under 21 CFR 10.25
(initiation of administrative
proceedings). A petition for
reconsideration must contain a full
statement in a well-organized format of
the factual and legal grounds upon
which the petition relies. The grounds
must demonstrate that relevant
information and views contained in the
administrative record were not
previously or not adequately considered
by the Commissioner. The respondent
must submit a petition no later than 30
days after the decision involved.
However, the Commissioner may, for
good cause, permit a petition to be filed
after 30 days. An interested person who
wishes to rely on information or views
not included in the administrative
record shall submit them with a new
petition to modify the decision. FDA
uses the information provided in the
request to determine whether to grant
the petition for reconsideration.
Respondents to this collection of
information are individuals of
households, State or local governments,
not-for-profit institutions, and
businesses or other for-profit
institutions who are requesting from the
Commissioner a reconsideration of a
matter.
Section 10.35 (21 CFR 10.35), issued
under section 701(a) of the FD&C Act,
sets forth the format and procedures by
which an interested person may request,
in accordance with § 10.20 (submission
of documents to Division of Dockets
Management), the Commissioner to stay
the effective date of any administrative
action.
Such a petition must do the following:
(1) Identify the decision involved; (2)
state the action requested, including the
E:\FR\FM\07SEN1.SGM
07SEN1
55397
Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Notices
length of time for which a stay is
requested; and (3) include a statement of
the factual and legal grounds on which
the interested person relies in seeking
the stay. FDA uses the information
provided in the request to determine
whether to grant the petition for stay of
action.
Respondents to this information
collection are interested persons who
choose to file a petition for an
administrative stay of action.
Section 10.85 (21 CFR 10.85), issued
under section 701(a) of the FD&C Act
sets forth the format and procedures by
which an interested person may request,
in accordance with § 10.20 (submission
of documents to Division of Dockets
Management), an advisory opinion from
the Commissioner on a matter of general
applicability. An advisory opinion
represents the formal position of FDA
on a matter of general applicability.
When making a request, the petitioner
must provide a concise statement of the
issues and questions on which an
opinion is requested, and a full
statement of the facts and legal points
relevant to the request. Respondents to
this collection of information are
interested persons seeking an advisory
opinion from the Commissioner on the
Agency’s formal position for matters of
general applicability.
FDA estimates the burden of this
collection of information as follows:
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
Total annual
responses
Average
burden per
response
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
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 and experience over the
past 3 years. In 2010, FDA received
approximately 207 petitions (§ 10.30), 4
administrative reconsiderations of
action (§ 10.33), 5 administrative stays
of action (§ 10.35), and 4 advisory
opinions (§ 10.85).
Dated: August 30, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2011–22857 Filed 9–6–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
emcdonald on DSK5VPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Vaccines and
Related Biological Products Advisory
Committee.
General Function of the Committee:
To provide advice and
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17:37 Sep 06, 2011
Jkt 223001
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on November 16, 2011, from 8 a.m.
to approximately 5:30 p.m.
Location: Hilton Washington DC/
Silver Spring, 8727 Colesville Rd.,
Silver Spring, MD 20910, 301–589–
5200. For those unable to attend in
person, the meeting will also be Web
cast. The link for the Web cast is
available at https://fda.yorkcast.com/
webcast/Viewer/?peid=75dcd91903
204870aff160cb9d5528151d.
Contact Person: Donald W. Jehn or
Denise Royster, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On November 16, 2011, the
committee will meet in open session to
hear an overview of the research
program in the Laboratory of Method
Development, Division of Viral
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
Products, Office of Vaccines Research
and Review, Center for Biologics
Evaluation and Research, FDA. The
committee will also hear an update on
the evaluation of Gullian-Barre
Syndrome after Influenza Vaccine
among Medicare population, 2010–
2011. The committee will then discuss
and make recommendations on the
safety and immunogenicity (surrogate
endpoint) of Pneumococcal 13-valent
conjugate vaccine (Diphtheria CRM197
Protein) in adults aged 50 years and
older using an accelerated approval
regulatory pathway.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: On November 16, 2011,
from 8 a.m. to approximately 9:30 a.m.
and from 10:15 a.m. to approximately
5:30 p.m., the meeting is open to the
public. Interested persons may present
data, information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
November 9, 2011. Oral presentations
from the public will be scheduled
between approximately 3:30 p.m. and
E:\FR\FM\07SEN1.SGM
07SEN1
]]>Agencies
[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Notices]
[Pages 55396-55397]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22857]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0627]
Agency Information Collection Activities; Proposed Collection;
Comment Request; General Administrative Procedures: Citizen Petitions;
Petition for Reconsideration or Stay of Action; Advisory Opinions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the reporting requirements
contained in existing FDA regulations regarding the general
administrative procedures for a person to petition the Commissioner of
Food and Drugs (the Commissioner) to issue, amend, or revoke a rule; to
file a petition for an administrative reconsideration or an
administrative stay of action; and to request an advisory opinion from
the Commissioner.
DATES: Submit either electronic or written comments on the collection
of information by November 7, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
General Administrative Procedures: Citizen Petitions; Petition for
Reconsideration or Stay of Action; Advisory Opinions--(OMB Control
Number 0910-0183)--Extension
The Administrative Procedures Act (5 U.S.C. 553(e)), provides that
every Agency shall give an interested person the right to petition for
issuance, amendment, or repeal of a rule. Section 10.30 (21 CFR 10.30)
sets forth the format and procedures by which an interested person may
submit to FDA, in accordance with Sec. 10.20 (21 CFR 10.20)
(submission of documents to Division of Dockets Management), a citizen
petition requesting the Commissioner to issue, amend, or revoke a
regulation or order, or to take or refrain from taking any other form
of administrative action.
The Commissioner may grant or deny such a petition, in whole or in
part, and may grant such other relief or take other action as the
petition warrants. Respondents are individuals or households, State or
local governments, not-for-profit institutions or groups.
Section 10.33 (21 CFR 10.33) issued under section 701(a) of the
Federal, Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
371(a)), sets forth the format and procedures by which an interested
person may request reconsideration of part or all of a decision of the
Commissioner on a petition submitted under 21 CFR 10.25 (initiation of
administrative proceedings). A petition for reconsideration must
contain a full statement in a well-organized format of the factual and
legal grounds upon which the petition relies. The grounds must
demonstrate that relevant information and views contained in the
administrative record were not previously or not adequately considered
by the Commissioner. The respondent must submit a petition no later
than 30 days after the decision involved. However, the Commissioner
may, for good cause, permit a petition to be filed after 30 days. An
interested person who wishes to rely on information or views not
included in the administrative record shall submit them with a new
petition to modify the decision. FDA uses the information provided in
the request to determine whether to grant the petition for
reconsideration. Respondents to this collection of information are
individuals of households, State or local governments, not-for-profit
institutions, and businesses or other for-profit institutions who are
requesting from the Commissioner a reconsideration of a matter.
Section 10.35 (21 CFR 10.35), issued under section 701(a) of the
FD&C Act, sets forth the format and procedures by which an interested
person may request, in accordance with Sec. 10.20 (submission of
documents to Division of Dockets Management), the Commissioner to stay
the effective date of any administrative action.
Such a petition must do the following: (1) Identify the decision
involved; (2) state the action requested, including the
[[Page 55397]]
length of time for which a stay is requested; and (3) include a
statement of the factual and legal grounds on which the interested
person relies in seeking the stay. FDA uses the information provided in
the request to determine whether to grant the petition for stay of
action.
Respondents to this information collection are interested persons
who choose to file a petition for an administrative stay of action.
Section 10.85 (21 CFR 10.85), issued under section 701(a) of the
FD&C Act sets forth the format and procedures by which an interested
person may request, in accordance with Sec. 10.20 (submission of
documents to Division of Dockets Management), an advisory opinion from
the Commissioner on a matter of general applicability. An advisory
opinion represents the formal position of FDA on a matter of general
applicability. When making a request, the petitioner must provide a
concise statement of the issues and questions on which an opinion is
requested, and a full statement of the facts and legal points relevant
to the request. Respondents to this collection of information are
interested persons seeking an advisory opinion from the Commissioner on
the Agency's formal position for matters of general applicability.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
10.30........................... 207 1 207 24 4,968
10.33........................... 4 1 4 10 40
10.35........................... 5 1 5 10 50
10.85........................... 4 1 4 16 64
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 5,122
----------------------------------------------------------------------------------------------------------------
\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 and experience over the past 3 years. In 2010, FDA
received approximately 207 petitions (Sec. 10.30), 4 administrative
reconsiderations of action (Sec. 10.33), 5 administrative stays of
action (Sec. 10.35), and 4 advisory opinions (Sec. 10.85).
Dated: August 30, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-22857 Filed 9-6-11; 8:45 am]
BILLING CODE 4160-01-P
