Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Evaluation and Assessment of HRSA Teaching Health Centers, 95620-95621 [2016-31353]

Download as PDF 95620 Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices phase of the regulatory review period, while 457 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: May 25, 2005. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on May 25, 2005. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): July 28, 2014. FDA has verified the applicant’s claim that the biologics license application (BLA) for IMLYGIC (BLA 125518) was initially submitted on July 28, 2014. 3. The date the application was approved: October 27, 2015. FDA has verified the applicant’s claim that BLA 125518 was approved on October 27, 2015. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,826 days, 1,764 days, or 1400 days, respectively, of patent term extension. sradovich on DSK3GMQ082PROD with NOTICES III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: December 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–31322 Filed 12–27–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 18:54 Dec 27, 2016 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Dated: December 22, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–31391 Filed 12–27–16; 8:45 am] BILLING CODE 4164–01–P [Docket No. FDA–2010–N–0067] Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting’’ that appeared in the Federal Register of November 29, 2016 (81 FR 85978). The document announced the forthcoming public advisory committee meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. The document was published with an error in the DATES section. This document corrects that error. SUMMARY: FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, FAX: 301–847–8533, email: ACPS-CP@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at http:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, November 29, 2016, in FR Doc. 2016– 28723, the following correction is made: On page 85978, in the third column, in the DATES section, the following sentence is to be inserted after the first sentence: ‘‘FDA is opening a docket for public comment on this meeting. The docket number is FDA–2010–N–0067. The docket will open for public comment on December 28, 2016. The docket will close on April 14, 2017.’’ PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 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; Evaluation and Assessment of HRSA Teaching Health Centers Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, 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 no later than January 27, 2017. ADDRESSES: Submit your comments, including the ICR 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: Evaluation and Assessment of HRSA Teaching Health Centers. OMB No. 0915–0376—Extension. Abstract: The Teaching Health Center Graduate Medical Education (THCGME) program supports new and the expansion of 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 and dentists 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. SUMMARY: E:\FR\FM\28DEN1.SGM 28DEN1 95621 Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices Need and Proposed Use of the Information: To ensure these goals are achieved, the George Washington University (GW) is conducting 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 questionnaires for implementation with all THC matriculating residents, graduating residents, and graduated residents at one 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. Statute requires that THCGME program award recipients 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. The described data collection activities will serve to meet this statutory requirement for the THCGME program award recipients in a uniform and consistent manner and will allow comparisons of this group to other trainees in non-THC programs. HRSA seeks renewal of these measures with no changes. Likely Respondents: This data collection includes documents that are completed separately by THC Program Directors and residents. THC Program Directors who have not already completed the program data collection tool will respond to the part of the data collection tool related to the characteristics of the programs. Annual updates are made on an as-needed basis. THC matriculating residents, graduating residents and graduated residents at one 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 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 Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours Program Data Collection Tool ............................................. THC Alumni Survey ............................................................. THC Matriculant Survey ....................................................... THC Graduation Survey ...................................................... 10 200 200 200 1 1 1 1 10 200 200 200 8 0.33 0.25 0.25 80 66 50 50 Total .............................................................................. 610 ........................ 610 ........................ 246 Jason E. Bennett, Director, Division of the Executive Secretariat. [FR Doc. 2016–31353 Filed 12–27–16; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Small Health Care Provider Quality Improvement Program Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. sradovich on DSK3GMQ082PROD with NOTICES AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the SUMMARY: VerDate Sep<11>2014 18:54 Dec 27, 2016 Jkt 241001 Paperwork Reduction Act of 1995), 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 ICR must be received no later than February 27, 2017. Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N–39, 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. ADDRESSES: PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: Small Health Care Provider Quality Improvement Program OMB No. 0915–0387—Extension Abstract: This program is authorized by Title III, Public Health Service Act, Section 330A(g) (42 U.S.C. 254c(g)), as amended by Section 201, P.L. 107–251, and Section 4, P.L. 110–355. This authority directs the Federal Office of Rural Health Policy (FORHP) to support grants that expand access to, coordinate, contain the cost of, and improve the quality of essential health care services, including preventive and emergency services, through the development of health care networks in rural and frontier areas and regions. Across these various programs, the authority allows HRSA to provide funds to rural and SUPPLEMENTARY INFORMATION: E:\FR\FM\28DEN1.SGM 28DEN1

Agencies

[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Notices]
[Pages 95620-95621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31353]


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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; Evaluation and Assessment 
of HRSA Teaching Health Centers

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, 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 no later than January 
27, 2017.

ADDRESSES: Submit your comments, including the ICR 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: 
Evaluation and Assessment of HRSA Teaching Health Centers.
    OMB No. 0915-0376--Extension.
    Abstract: The Teaching Health Center Graduate Medical Education 
(THCGME) program supports new and the expansion of 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 and dentists 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.

[[Page 95621]]

    Need and Proposed Use of the Information: To ensure these goals are 
achieved, the George Washington University (GW) is conducting 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 questionnaires for implementation with all THC matriculating 
residents, graduating residents, and graduated residents at one 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.
    Statute requires that THCGME program award recipients 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. The 
described data collection activities will serve to meet this statutory 
requirement for the THCGME program award recipients in a uniform and 
consistent manner and will allow comparisons of this group to other 
trainees in non-THC programs. HRSA seeks renewal of these measures with 
no changes.
    Likely Respondents: This data collection includes documents that 
are completed separately by THC Program Directors and residents. THC 
Program Directors who have not already completed the program data 
collection tool will respond to the part of the data collection tool 
related to the characteristics of the programs. Annual updates are made 
on an as-needed basis. THC matriculating residents, graduating 
residents and graduated residents at one 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 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 of         Total        burden  per    Total  burden
            Form name               respondents    responses per     responses     response  (in       hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Program Data Collection Tool....              10               1              10               8              80
THC Alumni Survey...............             200               1             200            0.33              66
THC Matriculant Survey..........             200               1             200            0.25              50
THC Graduation Survey...........             200               1             200            0.25              50
                                 -------------------------------------------------------------------------------
    Total.......................             610  ..............             610  ..............             246
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Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-31353 Filed 12-27-16; 8:45 am]
BILLING CODE 4165-15-P