Agency Information Collection Activities: Proposed Collection: Public Comment Request, 55729-55730 [2013-22111]

Download as PDF Federal Register / Vol. 78, No. 176 / Wednesday, September 11, 2013 / Notices Together; (9) FDA Conduct of Clinical Investigator Inspections; (10) Investigator Initiated Research; (11) Meetings with FDA—Why, When, and How; (12) Part 11 Compliance— Electronic Signatures; (13) IRB Regulations and FDA Inspections; (14) Informed Consent Regulations; (15) The Inspection is Over—What Happens Next? Possible FDA Compliance Actions; and (16) Question and Answer Session/Panel Discussion. FDA has made education of the drug and device manufacturing community a high priority to help ensure the safety and effectiveness of FDA-regulated drugs and devices. The public workshop helps to achieve objectives set forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393) which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The public workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104– 121), as outreach activities by Government Agencies to small businesses. Dated: September 6, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–22115 Filed 9–10–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:50 Sep 10, 2013 Jkt 229001 estimate below, or any other aspect of the ICR. DATES: Comments on this Information Collection Request must be received within 60 days of this notice. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 10–29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: Uniform Project Description and Application Guide—SF 424 NonConstruction. OMB No. 0915-xxxx—New. Abstract: The Health Resources and Services Administration is requesting clearance for the Uniform Project Description (UPD) and Application Guide to be used in conjunction with the SF–424 Non-Construction application kit by program offices to solicit application information for grants and cooperative agreements. Need and Proposed Use of the Information: The HRSA SF–424 Application Guide provides detailed standard instructions to help applicants prepare and submit applications electronically to HRSA through Grants.gov. The Guide is used in conjunction with the HRSA UPD that provides a menu of narratives from which the program office can select for inclusion within a program-specific grant or cooperative agreement funding opportunity announcement (FOA). UPD text options selected for use in a given FOA define the required project description portion to the applicant. The ability to pick and choose standard language that is appropriate for any given FOA reduces the burden associated with application preparation by eliminating irrelevant portions of the application for a given announcement. In addition, it provides consistency in the application review process. Much of the information required in applications for project grants and PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 55729 cooperative agreements is required by HHS Uniform Administrative Requirements for Grants and Cooperative Agreements at the following citations: 45 CFR part 74, 45 CFR part 92, applicable program regulations in 42 CFR chapters I and IV, and applicable administrative regulations in 45 CFR subtitle A. HRSA program offices, grants management officials, and expert nonfederal and federal panel reviewers use the collected information provided through grant applications to select and award discretionary grants. Program offices use the information to ensure that the authorizing legislation and applicable program regulations will be implemented through any funded project, and that applicant entities are eligible to receive HRSA funds. Expert non-federal and federal objective review panelists score the information provided in applications as they evaluate applications in the context of the FOA’s published criteria to ensure that the best proposed projects are recommended for funding. Grants management officials use the information to ensure appropriate federal stewardship of federal grant funds and that proposed budgeted project costs are allowable, allocable, and reasonable. Likely Respondents: Eligible organizations may include state, local, and Indian Tribal governments; institutions of higher education; other non-profit organizations (including faith-based, community-based, and Tribal organizations); and hospitals. In limited cases, foreign organizations may apply. 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 Information Collection Request are summarized in the table below. E:\FR\FM\11SEN1.SGM 11SEN1 55730 Federal Register / Vol. 78, No. 176 / Wednesday, September 11, 2013 / Notices TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours SF–424 Non-Construction UPD and SF–424 Application Guide ................................................................................ 3,500 1 3,500 145 507,500 Total .............................................................................. 3,500 1 3,500 145 507,500 HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Dated: September 5, 2013. Bahar Niakan, Director, Division of Policy and Information Coordination. [FR Doc. 2013–22111 Filed 9–10–13; 8:45 am] BILLING CODE 4165–15–P 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 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. emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:50 Sep 10, 2013 Jkt 229001 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: Evaluation and Initial Assessment of HRSA Teaching Health Centers. OMB No. 0915–xxxx—NEW. Abstract: Section 5508 of the Affordable Care Act of 2010 (ACA) amended section 340H of the Public Health Service (PHS) Act to establish the Teaching Health Center Graduate Medical Education (THCGME) program to support the expansion of new and existing primary care residency training programs in community-based settings. The primary goals of the THCGME program are to increase the production of primary care doctors who are well prepared to practice in community settings, particularly with underserved populations, and to improve the overall number and geographic distribution of primary care providers. To ensure these goals are achieved, the George Washington University (GW) will conduct an evaluation of the training, administrative and organizational structures, clinical service, challenges, innovations, costs associated with training, and outcomes of teaching health centers (THCs). GW has developed a program data collection tool that assesses basic organizational and training characteristics of the programs (including program specialty, numbers trained, training sites, educational partners, and residency program financing), educational initiatives (particularly around training for changing health care delivery systems and community experiences), and health center characteristics (including current workforce and vacancies, clinical service provided by residents, and participation in workforce programs such as the National Health Service Corps). Questionnaires have also been developed for implementation with all THC matriculating residents, graduating residents, and graduated residents at 1 FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 year post-graduation. The matriculation questionnaire aims to collect background information on THC residents to better understand the characteristics of individuals who apply and are accepted to THC programs. The graduation questionnaire collects information on career plans. The alumni questionnaire collects information on career outcomes (including practice in primary care and in underserved settings) following graduation, as well as feedback on the quality of training. Need and Proposed Use of the Information: Statute requires that THC programs report annually on the types of primary care resident approved training programs provided, the number of approved training positions, the number who completed their residency at the end of the prior academic year and care for vulnerable populations living in underserved areas, and any other information as deemed appropriate by the Secretary (Section 340H(h)(1) of the PHS Act). The described data collection activities will serve to meet this statutory requirement for the THC programs in a uniform and consistent manner and will allow comparisons of this group to other trainees in non-THC programs (See also Section 241 of the PHS Act). Likely Respondents: THC Program Directors will respond to the part of the data collection tool related to the characteristics of the programs, and THC matriculating residents, graduating residents, and graduated residents at 1 year post-graduation will respond to the questionnaires related to characteristics of the residents. 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 E:\FR\FM\11SEN1.SGM 11SEN1

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[Federal Register Volume 78, Number 176 (Wednesday, September 11, 2013)]
[Notices]
[Pages 55729-55730]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22111]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995), the Health Resources and Services 
Administration (HRSA) announces plans to submit an Information 
Collection Request (ICR), described below, to the Office of Management 
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks 
comments from the public regarding the burden estimate below, or any 
other aspect of the ICR.

DATES: Comments on this Information Collection Request must be received 
within 60 days of this notice.

ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA 
Information Collection Clearance Officer, Room 10-29, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
draft instruments, email paperwork@hrsa.gov or call the HRSA 
Information Collection Clearance Officer at (301) 443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    Information Collection Request Title: Uniform Project Description 
and Application Guide--SF 424 Non-Construction.
    OMB No. 0915-xxxx--New.
    Abstract: The Health Resources and Services Administration is 
requesting clearance for the Uniform Project Description (UPD) and 
Application Guide to be used in conjunction with the SF-424 Non-
Construction application kit by program offices to solicit application 
information for grants and cooperative agreements.
    Need and Proposed Use of the Information: The HRSA SF-424 
Application Guide provides detailed standard instructions to help 
applicants prepare and submit applications electronically to HRSA 
through Grants.gov. The Guide is used in conjunction with the HRSA UPD 
that provides a menu of narratives from which the program office can 
select for inclusion within a program-specific grant or cooperative 
agreement funding opportunity announcement (FOA). UPD text options 
selected for use in a given FOA define the required project description 
portion to the applicant. The ability to pick and choose standard 
language that is appropriate for any given FOA reduces the burden 
associated with application preparation by eliminating irrelevant 
portions of the application for a given announcement. In addition, it 
provides consistency in the application review process.
    Much of the information required in applications for project grants 
and cooperative agreements is required by HHS Uniform Administrative 
Requirements for Grants and Cooperative Agreements at the following 
citations: 45 CFR part 74, 45 CFR part 92, applicable program 
regulations in 42 CFR chapters I and IV, and applicable administrative 
regulations in 45 CFR subtitle A.
    HRSA program offices, grants management officials, and expert non-
federal and federal panel reviewers use the collected information 
provided through grant applications to select and award discretionary 
grants. Program offices use the information to ensure that the 
authorizing legislation and applicable program regulations will be 
implemented through any funded project, and that applicant entities are 
eligible to receive HRSA funds. Expert non-federal and federal 
objective review panelists score the information provided in 
applications as they evaluate applications in the context of the FOA's 
published criteria to ensure that the best proposed projects are 
recommended for funding. Grants management officials use the 
information to ensure appropriate federal stewardship of federal grant 
funds and that proposed budgeted project costs are allowable, 
allocable, and reasonable.
    Likely Respondents: Eligible organizations may include state, 
local, and Indian Tribal governments; institutions of higher education; 
other non-profit organizations (including faith-based, community-based, 
and Tribal organizations); and hospitals. In limited cases, foreign 
organizations may apply.
    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 Information Collection Request are summarized in the table below.

[[Page 55730]]



                                     Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of         Total        burden per     Total burden
            Form name               respondents    responses per     responses     response  (in       hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
SF-424 Non-Construction UPD and            3,500               1           3,500             145         507,500
 SF-424 Application Guide.......
                                 -------------------------------------------------------------------------------
    Total.......................           3,500               1           3,500             145         507,500
----------------------------------------------------------------------------------------------------------------

    HRSA specifically requests comments on (1) the necessity and 
utility of the proposed information collection for the proper 
performance of the agency's functions, (2) the accuracy of the 
estimated burden, (3) ways to enhance the quality, utility, and clarity 
of the information to be collected, and (4) the use of automated 
collection techniques or other forms of information technology to 
minimize the information collection burden.

    Dated: September 5, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-22111 Filed 9-10-13; 8:45 am]
BILLING CODE 4165-15-P