Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 9912-9913 [2014-03676]
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Federal Register / Vol. 79, No. 35 / Friday, February 21, 2014 / Notices
Dated: February 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–03704 Filed 2–20–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0179]
Training Program for Regulatory
Project Managers; Information
Available to Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA’s) Center for
Drug Evaluation and Research (CDER) is
announcing the continuation of the
Regulatory Project Management Site
Tours and Regulatory Interaction
Program (the Site Tours Program). The
purpose of this document is to invite
pharmaceutical companies interested in
participating in this program to contact
CDER.
DATES: Pharmaceutical companies may
submit proposed agendas to the Agency
by April 22, 2014.
FOR FURTHER INFORMATION CONTACT: Dan
Brum, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5480, Silver Spring,
MD 20993–0002, 301–796–0578,
dan.brum@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Background
An important part of CDER’s
commitment to make safe and effective
drugs available to all Americans is
optimizing the efficiency and quality of
the drug review process. To support this
primary goal, CDER has initiated
various training and development
programs to promote high performance
in its regulatory project management
staff. CDER seeks to significantly
enhance review efficiency and review
quality by providing the staff with a
better understanding of the
pharmaceutical industry and its
operations. To this end, CDER is
continuing its training program to give
regulatory project managers the
opportunity to tour pharmaceutical
facilities. The goals are to provide the
following: (1) Firsthand exposure to
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industry’s drug development processes,
and (2) a venue for sharing information
about project management procedures
(but not drug-specific information) with
industry representatives.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. The Site Tours Program
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
In this program, over a 2- to 3-day
period, small groups (five or less) of
regulatory project managers, including a
senior level regulatory project manager,
can observe operations of
pharmaceutical manufacturing and/or
packaging facilities, pathology/
toxicology laboratories, and regulatory
affairs operations. Neither this tour nor
any part of the program is intended as
a mechanism to inspect, assess, judge,
or perform a regulatory function, but is
meant rather to improve mutual
understanding and to provide an avenue
for open dialogue. During the Site Tours
Program, regulatory project managers
will also participate in daily workshops
with their industry counterparts,
focusing on selective regulatory issues
important to both CDER staff and
industry. The primary objective of the
daily workshops is to learn about the
team approach to drug development,
including drug discovery, preclinical
evaluation, tracking mechanisms, and
regulatory submission operations. The
overall benefit to regulatory project
managers will be exposure to project
management, team techniques, and
processes employed by the
pharmaceutical industry. By
participating in this program, the
regulatory project manager will grow
professionally by gaining a better
understanding of industry processes and
procedures.
III. Site Selection
All travel expenses associated with
the Site Tours Program will be the
responsibility of CDER; therefore,
selection will be based on the
availability of funds and resources for
each fiscal year. Selection will also be
based on firms having a favorable
facility status as determined by FDA’s
Office of Regulatory Affairs District
Offices in the firms’ respective regions.
Firms interested in offering a site tour
or learning more about this training
opportunity should respond by
submitting a proposed agenda to Dan
Brum (see DATES and FOR FURTHER
INFORMATION CONTACT).
Dated: February 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–03679 Filed 2–20–14; 8:45 am]
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Health Resources and Services
Administration
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received within 30 days of this notice.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
HRSA AIDS Drug Assistance Program
Quarterly Report OMB No. 0915–0294—
Extension.
Abstract: HRSA’s AIDS Drug
Assistance Program (ADAP) is funded
through Part B of Title XXVI of the
Public Health Service Act, as amended
by the Ryan White HIV/AIDS Treatment
Extension Act of 2009 (The Ryan White
HIV/AIDS Program), which provides
grants to states and territories. ADAP
provides medications for the treatment
of HIV disease. Program funds may also
be used to purchase health insurance for
eligible clients or for services that
enhance access, adherence, and
monitoring of drug treatments.
Need and Proposed Use of the
Information: Each of the 50 states, the
District of Columbia, Puerto Rico, the
Virgin Islands, and the Pacific territories
receive ADAP grants. As part of the
funding requirements, ADAP grantees
submit quarterly reports that include
information on patients served,
SUMMARY:
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Federal Register / Vol. 79, No. 35 / Friday, February 21, 2014 / Notices
pharmaceuticals dispensed, pricing,
sources of support to provide HIV/AIDS
medications, eligibility requirements,
costs data, and coordination with
Medicaid. Each quarterly report requests
updates from programs on the number
of patients served, type of
pharmaceuticals dispensed, and prices
paid to provide medications. The first
quarterly report of each ADAP fiscal
year (due in July of each year) also
requests information that only changes
annually (e.g., state funding, drug
formulary, eligibility criteria for
enrollment, and cost-saving strategies
including coordination with Medicaid).
The quarterly report is used to
determine how ADAP grants are being
expended and to provide answers to
requests from Congress and other
organizations.
Likely Respondents: Each of the 50
states, the District of Columbia, Puerto
Rico, the Virgin Islands, and the Pacific
territories that receive ADAP grants.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
ADAP Quarterly Report (Only Section 1 required for 4th quarterly report) ....
Dated: February 12, 2014.
Jackie Painter,
Deputy Director, Division of Policy and
Information Coordination.
Fish and Wildlife Service
[FWS–R4–ES–2013–N215; 40120–1112–
0000–F2]
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Endangered and Threatened Wildlife
and Plants; Programmatic Incidental
Take Permit Application and
Environmental Assessment for
Development Activities; Charlotte
County, FL
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Special Emphasis Panel,
February 27, 2014, 01:00 p.m. to
February 27, 2014, 04:30 p.m., National
Institutes of Health, 6701 Rockledge
Drive, Bethesda, MD, 20892 which was
published in the Federal Register on
February 6, 2014, 79 FR 7219.
The meeting will be held on March
11, 2014. The location and time remain
the same. The meeting is closed to the
public.
Dated: February 12, 2014.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
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[FR Doc. 2014–03660 Filed 2–19–14; 8:45 am]
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DEPARTMENT OF THE INTERIOR
[FR Doc. 2014–03676 Filed 2–20–14; 8:45 am]
Fish and Wildlife Service,
Interior.
ACTION: Notice of availability; request
for comments.
AGENCY:
Under the Endangered
Species Act of 1973, as amended (Act),
we, the U.S. Fish and Wildlife Service,
announce the receipt and availability of
a proposed county-wide programmatic
habitat conservation plan (HCP) and
accompanying documents for private
and commercial development projects,
public works, and municipal
infrastructure improvements (activities)
regulated or authorized by the Charlotte
County Board of County Commissioners
(applicant). If approved, the permit
would authorize incidental take of
Florida scrub-jay (scrub-jay) and eastern
indigo snake (indigo snake), in the
course of activities conducted or
permitted by the applicant in Charlotte
County, FL. We invite the public to
comment on these documents.
DATES: To ensure consideration, please
send your written comments by April
22, 2014.
ADDRESSES: Documents are available for
public inspection by appointment
SUMMARY:
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Number
responses
per
respondent
Average
burden per
response
(in hours)
1
17
Total burden
hours
969
during regular business hours at the
Fish and Wildlife Service’s Regional
Office, 1875 Century Boulevard, Suite
200, Atlanta, GA 30345; or the South
Florida Field Office, Fish and Wildlife
Service, 1339 20th Street, Vero Beach,
FL 32960.
FOR FURTHER INFORMATION CONTACT: Mr.
David Dell, Regional HCP Coordinator,
(see ADDRESSES), telephone: 404–679–
7313; or Ms. Elizabeth Landrum, Field
Office Project Manager, at the South
Florida Field Office (see ADDRESSES),
telephone: 772–469–4304. If you use a
telecommunications device for the deaf
(TDD), please call the Federal
Information Relay Service (FIRS) at
800–877–8339.
SUPPLEMENTARY INFORMATION: We
announce the availability of the
proposed HCP, accompanying
incidental take permit (ITP) application,
and an environmental assessment (EA),
which analyze the take of the scrub-jay
(Aphelocoma coerulescens) and indigo
snake (Drymarchon courais cooperii)
incidental to activities conducted or
permitted by the applicant. The
applicant requests a 30-year ITP under
section 10(a)(1)(B) of the Act, as
amended (16 U.S.C. 1531 et seq.). The
applicant’s HCP describes the mitigation
and minimization measures proposed to
address the impacts to the species.
We specifically request information,
views, and opinions from the public on
our proposed Federal action, including
identification of any other aspects of the
human environment not already
identified in the EA pursuant to
National Environmental Policy Act
(NEPA) regulations in the Code of
Federal Regulations (CFR) at 40 CFR
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]]>Agencies
[Federal Register Volume 79, Number 35 (Friday, February 21, 2014)]
[Notices]
[Pages 9912-9913]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03676]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health Resources and Services Administration
(HRSA) has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period.
DATES: Comments on this ICR should be received within 30 days of this
notice.
ADDRESSES: Submit your comments, including the Information Collection
Request Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: HRSA AIDS Drug Assistance
Program Quarterly Report OMB No. 0915-0294--Extension.
Abstract: HRSA's AIDS Drug Assistance Program (ADAP) is funded
through Part B of Title XXVI of the Public Health Service Act, as
amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (The
Ryan White HIV/AIDS Program), which provides grants to states and
territories. ADAP provides medications for the treatment of HIV
disease. Program funds may also be used to purchase health insurance
for eligible clients or for services that enhance access, adherence,
and monitoring of drug treatments.
Need and Proposed Use of the Information: Each of the 50 states,
the District of Columbia, Puerto Rico, the Virgin Islands, and the
Pacific territories receive ADAP grants. As part of the funding
requirements, ADAP grantees submit quarterly reports that include
information on patients served,
[[Page 9913]]
pharmaceuticals dispensed, pricing, sources of support to provide HIV/
AIDS medications, eligibility requirements, costs data, and
coordination with Medicaid. Each quarterly report requests updates from
programs on the number of patients served, type of pharmaceuticals
dispensed, and prices paid to provide medications. The first quarterly
report of each ADAP fiscal year (due in July of each year) also
requests information that only changes annually (e.g., state funding,
drug formulary, eligibility criteria for enrollment, and cost-saving
strategies including coordination with Medicaid). The quarterly report
is used to determine how ADAP grants are being expended and to provide
answers to requests from Congress and other organizations.
Likely Respondents: Each of the 50 states, the District of
Columbia, Puerto Rico, the Virgin Islands, and the Pacific territories
that receive ADAP grants.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number burden per Total burden
Form name respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
ADAP Quarterly Report (Only Section 1 required 57 1 17 969
for 4th quarterly report)......................
----------------------------------------------------------------------------------------------------------------
Dated: February 12, 2014.
Jackie Painter,
Deputy Director, Division of Policy and Information Coordination.
[FR Doc. 2014-03676 Filed 2-20-14; 8:45 am]
BILLING CODE 4165-15-P
