Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions, 10255-10256 [E9-4972]
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10255
Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Notices
information to be submitted to the DMC,
FDA, or the sponsor. The ‘‘Hours per
Record’’ include the time to record,
gather, and maintain the information.
The information collection provisions
in the guidance for §§ 312.30 (21 CFR
312.30), 312.32, 312.38 (21 CFR 312.38),
312.55 (21 CFR 312.55), and 312.56
have been approved under OMB control
no. 0910–0014; § 314.50 has been
approved under OMB control no. 0910–
0001; and §§ 812.35 (21 CFR 812.35)
and 812.150 have been approved under
OMB control no. 0910–0078.
In the Federal Register of October 8,
2008 (73 FR 58970), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Section of Guidance/Reporting
Activity
No. of
Respondents
Annual Frequency
per Response
4.4.1.2. Sponsor notification to
the DMC regarding waivers
Total Annual
Responses
Hours Per
Response
Total Hours
1
1
1
.25
.25
4.4.3.2. DMC reports of meeting
minutes to the sponsor
370
2
740
1
740
5. Sponsor reporting to FDA on
DMC recommendations related
to safety
37
1
37
.5
18.5
Total
758.75
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
Recordkeeping Activity
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours Per
Record
Total Hours
4.1. and 6.4 SOPs for DMCs
37
1
37
8
296
4.4.3.2. DMC meeting records
370
1
370
2
740
Total
1,036
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 3, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–4971 Filed 3–9–09; 8:45 am]
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 9,
2009.
BILLING CODE 4160–01–S
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0183. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0650]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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
that a proposed collection of
information has been submitted to the
Office of Management and Budget
VerDate Nov<24>2008
15:20 Mar 09, 2009
Jkt 217001
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3792.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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 of Food and Drugs (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 and
businesses or other for-profit
institutions or groups.
E:\FR\FM\10MRN1.SGM
10MRN1
10256
Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Notices
Section 10.33 (21 CFR 10.33) issued
under section 701(a) of the Federal,
Food, Drug, and Cosmetic Act (the 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 of FDA a reconsideration
of a matter.
Section 10.35 (21 CFR 10.35), issued
under section 701(a) of the 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
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 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.
In the Federal Register of December
30, 2008 (73 FR 79885), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
10.30
162
3
486
12
5,832
10.33
4
2
8
10
80
10.35
7
2
14
10
140
10.85
2
1
2
16
32
Total
1There
6,084
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 2007, FDA received
approximately 162 citizen petitions
(§ 10.30), 4 administrative
reconsiderations of action (§ 10.33), 7
administrative stays of action (§ 10.35),
and 2 advisory opinions (§ 10.85).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: March 3, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–4972 Filed 3–9–09; 8:45 am]
HHS.
BILLING CODE 4160–01–S
VerDate Nov<24>2008
15:20 Mar 09, 2009
Jkt 217001
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Endocrinologic
and Metabolic Drugs Advisory
Committee.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on April 1 and 2, 2009, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The
hotel telephone number is 301–589–
5200.
Contact Person: Paul Tran, Center for
Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–7001, FAX: 301–
827–6776, e-mail:
paul.tran@fda.hhs.gov, or FDA
Advisory Committee Information Line,
E:\FR\FM\10MRN1.SGM
10MRN1
]]>Agencies
[Federal Register Volume 74, Number 45 (Tuesday, March 10, 2009)]
[Notices]
[Pages 10255-10256]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4972]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0650]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by April
9, 2009.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0183.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3792.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 of Food and Drugs (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 and businesses or other
for-profit institutions or groups.
[[Page 10256]]
Section 10.33 (21 CFR 10.33) issued under section 701(a) of the
Federal, Food, Drug, and Cosmetic Act (the 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 of FDA a reconsideration of a matter.
Section 10.35 (21 CFR 10.35), issued under section 701(a) of the
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 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
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.
In the Federal Register of December 30, 2008 (73 FR 79885), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.30 162 3 486 12 5,832
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.33 4 2 8 10 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.35 7 2 14 10 140
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.85 2 1 2 16 32
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 6,084
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 2007, FDA
received approximately 162 citizen petitions (Sec. 10.30), 4
administrative reconsiderations of action (Sec. 10.33), 7
administrative stays of action (Sec. 10.35), and 2 advisory opinions
(Sec. 10.85).
Dated: March 3, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4972 Filed 3-9-09; 8:45 am]
BILLING CODE 4160-01-S
