Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 9912-9913 [2014-03676]

Download as PDF 9912 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] BILLING CODE 4160–01–P 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: rmajette on DSK2TPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 14:09 Feb 20, 2014 Jkt 232001 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] BILLING CODE 4160–01–P PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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: E:\FR\FM\21FEN1.SGM 21FEN1 9913 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] BILLING CODE 4165–15–P 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. rmajette on DSK2TPTVN1PROD with NOTICES [FR Doc. 2014–03660 Filed 2–19–14; 8:45 am] BILLING CODE 4140–01–P VerDate Mar<15>2010 14:09 Feb 20, 2014 Jkt 232001 57 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: PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 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 E:\FR\FM\21FEN1.SGM 21FEN1

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