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, 15762-15763 [2012-6392]
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Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices
compensation program. Key functions of
the ABRWH include providing advice
on the development of probability of
causation guidelines that have been
promulgated by the Department of
Health and Human Services (HHS) as a
final rule; advice on methods of dose
reconstruction which have also been
promulgated by HHS as a final rule;
advice on the scientific validity and
quality of dose estimation and
reconstruction efforts being performed
for purposes of the compensation
program; and advice on petitions to add
classes of workers to the Special
Exposure Cohort (SEC).
In December 2000, the President
delegated responsibility for funding,
staffing, and operating the ABRWH to
HHS, which subsequently delegated this
authority to CDC. NIOSH implements
this responsibility for CDC. The charter
was issued on August 3, 2001, renewed
at appropriate intervals, and will expire
on August 3, 2013.
Purpose: The ABRWH is charged with
(a) providing advice to the Secretary,
HHS, on the development of guidelines
under Executive Order 13179; (b)
providing advice to the Secretary, HHS,
on the scientific validity and quality of
dose reconstruction efforts performed
for this program; and (c) upon request
by the Secretary, HHS, advising the
Secretary on whether there is a class of
employees at any Department of Energy
facility who were exposed to radiation
but for whom it is not feasible to
estimate their radiation dose, and on
whether there is a reasonable likelihood
that such radiation doses may have
endangered the health of members of
this class. The Subcommittee on
Procedures Review was established to
aid the ABRWH in carrying out its duty
to advise the Secretary, HHS, on dose
reconstructions. The Subcommittee on
Procedures Review is responsible for
overseeing, tracking, and participating
in the reviews of all procedures used in
the dose reconstruction process by the
NIOSH Division of Compensation
Analysis and Support (DCAS) and its
dose reconstruction contractor.
Matters to be Discussed: The agenda
for the Subcommittee meeting includes
discussion of the following Oak Ridge
Associated Universities (ORAU) and
Division of Compensation Analysis and
Support (DCAS) procedures: Office of
Compensation Analysis and Support
(OCAS) TIB–0010 ‘‘Best Estimate
External Dose Reconstruction for
Glovebox Workers’’); DCAS TIB–0013
(‘‘Selected Geometric Exposure Scenario
Considerations for External Dose
Reconstruction at Uranium Facilities’’),
OTIB–0052 (‘‘Parameters to Consider
When Processing Claims for
VerDate Mar<15>2010
17:10 Mar 15, 2012
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Construction Trade Workers’’), OTIB–
0054 (‘‘Fission and Activation Product
Assignment for Internal Dose-Related
Gross Beta and Gross Gamma
Analyses’’), and PER 20 (‘‘Blockson TBD
Revision’’); Identification of
Overarching Dose Reconstruction
Issues; Discussion of Completed
Procedure Reviews for Summarization;
and a continuation of the commentresolution process for other dose
reconstruction procedures under review
by the Subcommittee.
The agenda is subject to change as
priorities dictate.
In the event an individual cannot
attend, written comments may be
submitted. Any written comments
received will be provided at the meeting
and should be submitted to the contact
person below well in advance of the
meeting.
Contact Person for More Information:
Theodore Katz, Executive Secretary,
NIOSH, CDC, 1600 Clifton Road NE.,
Mailstop E–20, Atlanta, Georgia 30333,
Telephone (513) 533–6800, Toll Free 1
(800) CDC–INFO, Email dcas@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: March 9, 2012.
John Kastenbauer,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2012–6475 Filed 3–15–12; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0627]
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.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 16,
2012.
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:
202–395–7285, or emailed 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: 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: 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 § 10.20 (21 CFR 10.20)
(submission of documents to Division of
Dockets Management), a citizen petition
requesting the Commissioner of FDA
(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
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Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices
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, 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 FD&C Act
sets forth the format and procedures by
which an interested person may request,
in accordance with § 10.20, 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 accordance with 5 CFR 1320.8(d),
FDA published a 60-day notice for
public comment in the Federal Register
of September 7, 2011 (76 FR 55396), to
which the Agency received one
comment. However, this comment did
not address the information collection.
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
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
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: March 12, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
DATES:
Food and Drug Administration
ADDRESSES:
[Docket No. FDA–2011–N–0625]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Filing Objections
and Requests for a Hearing on a
Regulation or Order
[FR Doc. 2012–6392 Filed 3–15–12; 8:45 am]
AGENCY:
BILLING CODE 4160–01–P
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
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.
17:10 Mar 15, 2012
Jkt 226001
PO 00000
Frm 00047
Fmt 4703
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:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0184. Also
include the FDA docket number found
in brackets in the heading of this
document.
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.
FOR FURTHER INFORMATION CONTACT:
Notice.
SUMMARY:
VerDate Mar<15>2010
Fax written comments on the
collection of information by April 16,
2012.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sfmt 4703
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
E:\FR\FM\16MRN1.SGM
16MRN1
]]>Agencies
[Federal Register Volume 77, Number 52 (Friday, March 16, 2012)]
[Notices]
[Pages 15762-15763]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6392]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0627]
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
16, 2012.
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: 202-395-7285, or emailed 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: 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: 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 FDA (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
[[Page 15763]]
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, 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
FD&C Act sets forth the format and procedures by which an interested
person may request, in accordance with Sec. 10.20, 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 accordance with 5 CFR 1320.8(d), FDA published a 60-day notice
for public comment in the Federal Register of September 7, 2011 (76 FR
55396), to which the Agency received one comment. However, this comment
did not address the information collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses 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: March 12, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6392 Filed 3-15-12; 8:45 am]
BILLING CODE 4160-01-P
