Agency Information Collection Activities; Proposed Collection; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine, 41264-41265 [2011-17532]
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41264
Federal Register / Vol. 76, No. 134 / Wednesday, July 13, 2011 / Notices
Fiscal Year Funds: 2011.
Anticipated Award Date: July 1, 2011.
Application Selection Process
Funding will be awarded to applicant
based on results from successful past
performance review.
mstockstill on DSK4VPTVN1PROD with NOTICES
Funding Authority
CDC will add the ACA Authority to
that which is reflected in the published
Funding Opportunity CDC–RFA–EH10–
1004. The revised funding authority
language will read:
—This program is authorized under
Sections 311 and 317(k)(2) of the
Public Health Service Act, [42 U.S.C.
Sections 243 and 247b(k)(2)] as
amended and the Patient Protection
and Affordable Care Act (ACA),
Section 4002 [42 U.S.C. 300u–11].
DATES: The effective date for this action
is the date of publication of this Notice
and remains in effect until the
expiration of the project period of the
ACA funded applications.
FOR FURTHER INFORMATION CONTACT:
Elmira Benson, Acting Deputy Director,
Procurement and Grants Office, Centers
for Disease Control and Prevention,
2920 Brandywine Road, Atlanta, GA
30341, telephone (770) 488–2802, e-mail
Elmira.Benson@cdc.gov.
SUPPLEMENTARY INFORMATION: On March
23, 2010, the President signed into law
the Affordable Care Act (ACA), Public
Law 111–148. ACA is designed to
improve and expand the scope of health
care coverage for Americans. Cost
savings through disease prevention is an
important element of this legislation
and ACA has established a Prevention
and Public Health Fund (PPHF) for this
purpose. Specifically, the legislation
states in Section 4002 that the PPHF is
to ‘‘provide for expanded and sustained
national investment in prevention and
public health programs to improve
health and help restrain the rate of
growth in private and public sector
health care costs.’’ ACA and the
Prevention and Public Health Fund
make improving public health a priority
with investments to improve public
health.
The PPHF states that the Secretary
shall transfer amounts in the Fund to
accounts within the Department of
Health and Human Services to increase
funding, over the fiscal year 2008 level,
for programs authorized by the Public
Health Service Act, for prevention,
wellness and public health activities
including prevention research and
health screenings, such as the
Community Transformation Grant
Program, the Education and Outreach
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17:36 Jul 12, 2011
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Campaign for Preventative Benefits, and
Immunization Programs.
ACA legislation affords an important
opportunity to advance public health
across the lifespan and to improve
public health by supporting the
Tracking Network. This network builds
on ongoing efforts within the public
health and environmental sectors to
improve health tracking, hazard
monitoring and response capacity.
Therefore, increasing funding available
to applicants under this FOA using the
PPHF will allow them to expand and
sustain their existing tracking networks,
utilize tracking data available on
networks for potential public health
assessments which is consistent with
the purpose of the PPHF, as stated
above, and to provide for an expanded
and sustained national investment in
prevention and public health programs.
Further, the Secretary allocated funds to
CDC, pursuant to the PPHF, for the
types of activities this FOA is designed
to carry out.
Dated: June 17, 2011.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2011–17601 Filed 7–12–11; 8:45 am]
BILLING CODE 4163–18–P
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0599. The
approval expires on June 13, 2014. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: July 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–17570 Filed 7–12–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0509]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Appeals of
Science-Based Decisions Above the
Division Level at the Center for
Veterinary Medicine
AGENCY:
Food and Drug Administration,
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0120]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Cosmetic Labeling Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Cosmetic Labeling Regulations’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
SUPPLEMENTARY INFORMATION: In the
Federal Register of May 28, 2010 (75 FR
30035), the Agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
SUMMARY:
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
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 information collection requirements
for appeals of science-based decisions
above the division level at the Center for
Veterinary Medicine (CVM).
DATES: Submit either electronic or
written comments on the collection of
information by September 12, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://www.fda.gov/
dockets/ecomments or 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
SUMMARY:
E:\FR\FM\13JYN1.SGM
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41265
Federal Register / Vol. 76, No. 134 / Wednesday, July 13, 2011 / Notices
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
Juanmanuel.vilela@fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
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.
Appeals of Science-Based Decisions
Above the Division Level at CVM—21
CFR Part 10.75 (OMB Control Number
0910–0566—Extension)
Respondents: Respondents to this
collection of information are applicants
that wish to submit a request for review
of a scientific dispute.
CVM’s Guidance for Industry #79—
‘‘Dispute Resolution Procedures for
Science-based Decisions on Products
Regulated by the Center for Veterinary
Medicine’’ describes the process by
which CVM formally resolves disputes
relating to scientific controversies. A
scientific controversy involves issues
concerning a specific product regulated
by CVM related to matters of technical
expertise and requires specialized
education, training, or experience to be
understood and resolved. Further, the
guidance details information on how the
Agency intends to interpret and apply
provisions of the existing regulations
regarding internal Agency review of
decisions. In addition, the guidance
outlines the established procedures for
persons who are sponsors, applicants, or
manufacturers, for animal drugs or other
products regulated by CVM, who wish
to submit a request for review of a
scientific dispute. When a sponsor,
applicant, or manufacturer has a
scientific disagreement with a written
decision by CVM, they may submit a
request for a review of that decision by
following the established Agency
channels of supervision for review.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
10.75 ....................................................................................
1 There
1
Average
burden per
response
Total annual
responses
3
3
Total hours
10
30
are no capital costs or operating and maintenance costs associated with this collection of information.
This estimated annual reporting
burden is based on CVM’s experience
over the past 3 years in handling formal
appeals for scientific disputes. The
number of respondents multiplied by
the number of responses per respondent
equals the total annual responses. The
average burden per response (in hours)
is based on discussions with industry
and may vary depending on the
complexity of the issue(s) involved and
the duration of the appeal process.
Dated: July 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–17532 Filed 7–12–11; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
Number of responses per
respondent
Number of
respondents
21 CFR section
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0567]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Restaurant Menu and Vending Machine
Labeling: Recordkeeping and
Mandatory Third Party Disclosure
Under Section 4205 of the Patient
Protection and Affordable Care Act of
2010
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Restaurant Menu and Vending
Machine Labeling: Recordkeeping and
Mandatory Third Party Disclosure
SUMMARY:
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17:36 Jul 12, 2011
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PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
Under Section 4205 of the Patient
Protection and Affordable Care Act of
2010’’ has been approved by the Office
of Management and Budget (OMB)
under the Paperwork Reduction Act of
1995.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
In the
Federal Register of January 31, 2011
(76 FR 5380), the Agency announced
that the proposed information collection
had been submitted to OMB for review
and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0665. The
SUPPLEMENTARY INFORMATION:
E:\FR\FM\13JYN1.SGM
13JYN1
]]>Agencies
[Federal Register Volume 76, Number 134 (Wednesday, July 13, 2011)]
[Notices]
[Pages 41264-41265]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17532]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0509]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Appeals of Science-Based Decisions Above the Division
Level at the Center for Veterinary Medicine
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 information collection
requirements for appeals of science-based decisions above the division
level at the Center for Veterinary Medicine (CVM).
DATES: Submit either electronic or written comments on the collection
of information by September 12, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.fda.gov/dockets/ecomments or 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
[[Page 41265]]
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
Juanmanuel.vilela@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.
Appeals of Science-Based Decisions Above the Division Level at CVM--21
CFR Part 10.75 (OMB Control Number 0910-0566--Extension)
Respondents: Respondents to this collection of information are
applicants that wish to submit a request for review of a scientific
dispute.
CVM's Guidance for Industry 79--``Dispute Resolution
Procedures for Science-based Decisions on Products Regulated by the
Center for Veterinary Medicine'' describes the process by which CVM
formally resolves disputes relating to scientific controversies. A
scientific controversy involves issues concerning a specific product
regulated by CVM related to matters of technical expertise and requires
specialized education, training, or experience to be understood and
resolved. Further, the guidance details information on how the Agency
intends to interpret and apply provisions of the existing regulations
regarding internal Agency review of decisions. In addition, the
guidance outlines the established procedures for persons who are
sponsors, applicants, or manufacturers, for animal drugs or other
products regulated by CVM, who wish to submit a request for review of a
scientific dispute. When a sponsor, applicant, or manufacturer has a
scientific disagreement with a written decision by CVM, they may submit
a request for a review of that decision by following the established
Agency channels of supervision for review.
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
----------------------------------------------------------------------------------------------------------------
10.75........................... 1 3 3 10 30
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
This estimated annual reporting burden is based on CVM's experience
over the past 3 years in handling formal appeals for scientific
disputes. The number of respondents multiplied by the number of
responses per respondent equals the total annual responses. The average
burden per response (in hours) is based on discussions with industry
and may vary depending on the complexity of the issue(s) involved and
the duration of the appeal process.
Dated: July 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-17532 Filed 7-12-11; 8:45 am]
BILLING CODE 4160-01-P
