Agency Information Collection Activities; Proposed Collection; Comment Request; Appeals of Science-Based Decisions Above the Division Level at the Center for Veterinary Medicine, 65976-65977 [2014-26307]
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Federal Register / Vol. 79, No. 215 / Thursday, November 6, 2014 / Notices
• Energy-related activities—Projects
that promote traditional energy
activities and practices that support
conservation and help to mitigate the
high costs of the purchase,
transportation, and storage of fuel in
Alaskan Villages, especially strategic
energy plans that have been identified
in tribally approved strategic energy
plans. Examples include projects to
implement renewable energy resources
at the Village level such as bio-energy,
geothermal, hydropower, solar, wind, or
other methods appropriate to the
geographical location.
• Infrastructure—Developing Villagelevel infrastructure (transportation
systems, communication, distribution
networks, financial institutions, etc.) to
support the Village workforce and to
make sustainable business activity
possible.
• Subsistence—Enhancing
subsistence and agricultural activities to
retain or revitalize traditional food
sources and practices at the Villagelevel.
(c) Social Development: Projects that
develop and implement culturally
appropriate strategies to meet the social
service needs of Alaska Natives.
Examples of Alaska-Specific program
areas of interest are:
• Community living—Development
and coordination of services to assist
people with disabilities by helping them
reach their maximum potential through
increased independence, productivity,
and integration within the Village
community.
• Early childhood education and
development—Supporting stable and
high-quality, culturally responsive early
childhood programs, creating early
childhood education and development
jobs, and improving Village level
planning and coordination of early
childhood education and development
programs.
• Youth development—Improving the
well-being of youth through life skills
training at the Village level, workforce
development, mentoring programs,
substance abuse programs, and
preventing suicides and juvenile crime.
• Community Health—Promoting
improved access to health care and
quality of care through coordinated
Village and regional approaches,
expanding access to healthy foods
available in Native Villages, and
supporting environmental health.
• Arts and culture—Developing or
enhancing activities, at the Village level
that promote, preserve, or restore Native
Village culture and arts.
• Rescue archaeology—Recovery of
cultural material due to climate change
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such as exposure of cultural artifacts
due to permafrost melting.
• Organizational Development—
Increasing organizational capacity at the
Village level to successfully implement
mission and goals.
• Nutrition and Fitness—Promoting
increased knowledge and participation
in activities that promote healthy foods,
active lifestyles, the reduction of
obesity, and other healthy-living habits
• Strengthening Families—
Incorporating culturally relevant
strategies to strengthen families and
promote family preservation,
responsible parenting, and healthy
relationship skills; and to foster the
well-being of children residing in
Villages
• Responsible Fatherhood—
Supporting responsible fatherhood
through activities such as counseling,
mentoring, marriage education,
enhancing relationship skills, parenting,
and activities to foster economic
stability
• Suicide Prevention—Promoting
safety, resilience, and protective factors
necessary to foster mental health and
reduce incidences of suicide and
suicidal ideation
• Human Trafficking—Development
of Village-level assessments and
strategies to address human trafficking,
including efforts to bring awareness of
human trafficking to the public,
development of prevention strategies to
address the needs of victims, and
establishment of collaborative
partnerships including those that train
public safety officials to recognize
traffickers and their victims.
C. Eligible Applicants
Applicants eligible under the AlaskaSpecific SEDS FOA are those listed in
45 CFR 1336.33(a)(2): that is, ‘‘(i)
Federally recognized Indian tribes in
Alaska; (ii) Alaska Native villages as
defined in the Alaska Native Claims
Settlement Act (ANSCA) and/or nonprofit village consortia; (iii)
Incorporated nonprofit Alaska Native
multi-purpose community-based
organizations; (iv) Nonprofit Alaska
Native Regional Corporations/
Associations in Alaska with village
specific projects; and (v) Nonprofit
Native organizations in Alaska with
village specific projects.’’ As this listing
already appears in our regulations we
are not seeking comment on this aspect
of the Alaska-Specific SEDS Projects.
Statutory Authority: This notice for public
comment is required by Section 814 of the
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Native American Programs Act of 1974
(NAPA), as amended.
Kimberly Romine,
Deputy Commissioner, Administration for
Native American.
[FR Doc. 2014–26426 Filed 11–5–14; 8:45 am]
BILLING CODE 4184–34–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.
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 electronic or written
comments on the collection of
information by January 5, 2015.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
SUMMARY:
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Federal Register / Vol. 79, No. 215 / Thursday, November 6, 2014 / Notices
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)—Revision
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
65977
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, that 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
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
10.75 ....................................................................................
2
4
8
10
80
mstockstill on DSK4VPTVN1PROD with NOTICES
CVM encourages applicants to begin
the resolution of science-based disputes
with discussions with the review team/
group, including the Team Leader or
Division Director. The Center prefers
that differences of opinion regarding
science or science-based policy be
resolved between the review team/group
and the applicant. If the matter is not
resolved by this preferred method, then
CVM recommends that the applicant
follow the procedure in Guidance for
Industry #79. Of the two respondents
who were advised on the procedure
during the past 3 years, one has not
followed up to initiate it and the other
is working with the review team/group
to resolve the issue(s). Therefore, this
estimated annual reporting burden is
based on CVM’s previous experience in
handling formal appeals for scientific
disputes.
Dated: October 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–26307 Filed 11–5–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0984]
Specification of the Unique Facility
Identifier System for Drug
Establishment Registration; Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Specification of the Unique
Facility Identifier (UFI) System for Drug
Establishment Registration.’’ This
guidance specifies the UFI system for
registration of domestic and foreign
drug establishments. The guidance
addresses provisions set forth in the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act), as amended by the Food
and Drug Administration Safety and
SUMMARY:
Innovation Act (FDASIA). This
guidance finalizes the draft guidance
issued on September 6, 2013.
Submit either electronic or
written comments on Agency guidances
at any time.
DATES:
Submit written requests for
single copies of the guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993; or
the Office of Communication, Outreach
and Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
ADDRESSES:
1 There are no capital costs or operating and
maintenance costs associated with this collection of
information.
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]]>Agencies
[Federal Register Volume 79, Number 215 (Thursday, November 6, 2014)]
[Notices]
[Pages 65976-65977]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26307]
-----------------------------------------------------------------------
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 electronic or written comments on the collection of
information by January 5, 2015.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the
[[Page 65977]]
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)--Revision
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,
that 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:
---------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance
costs associated with this collection of information.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
10.75.............................................................. 2 4 8 10 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
CVM encourages applicants to begin the resolution of science-based
disputes with discussions with the review team/group, including the
Team Leader or Division Director. The Center prefers that differences
of opinion regarding science or science-based policy be resolved
between the review team/group and the applicant. If the matter is not
resolved by this preferred method, then CVM recommends that the
applicant follow the procedure in Guidance for Industry #79. Of the two
respondents who were advised on the procedure during the past 3 years,
one has not followed up to initiate it and the other is working with
the review team/group to resolve the issue(s). Therefore, this
estimated annual reporting burden is based on CVM's previous experience
in handling formal appeals for scientific disputes.
Dated: October 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26307 Filed 11-5-14; 8:45 am]
BILLING CODE 4164-01-P
