Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program, 85579-85580 [2016-28443]

Download as PDF 85579 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Notices TABLE 9—SUMMARY OF STATUS OF POSTMARKETING COMMITMENTS ESTABLISHED 1 BETWEEN FY2009 AND FY2015 2— Continued [Numbers as of September 30, 2015] 3 PMC Status as of FY2015 (% of total PMCs in each establishment year) Fiscal year of PMC establishment 2009 2010 2011 2012 2013 2014 2015 Delayed ........................ Terminated ................... Released ...................... Fulfilled ......................... 6 (13%) 1 (2%) 4 (8%) 30 (63%) 12 (13%) 0 7 (7%) 44 (47%) 8 (10%) 0 10 (12%) 35 (43%) 6 (13%) 0 1 (2%) 22 (48%) 4 (9%) 0 1 (2%) 14 (30%) 0 0 0 10 (16%) 0 0 1 (2%) 1 (2%) Total 4 .................... 48 94 82 46 46 61 54 1 The establishment date is the date of the formal FDA communication to the applicant that included the final FDA required (PMR) or requested (PMC) postmarketing study or clinical trial. 2 The table shows data for PMCs that were closed (fulfilled or released) as of FY2015. Therefore, data for PMCs that were closed in prior fiscal years are included. 3 Percentages may not total 100 due to rounding. 4 The total number of PMRs/PMCs established in FY2009 through FY2014 reflects the data in FDA’s databases as of September 30, 2015. As a result of data corrections, as well as improvements in ascertainment of the PMR/PMC establishment date, some of the total numbers of PMRs/ PMCs established in each fiscal year are different from those reported in the prior fiscal year’s (FY2014) Federal Register report. Dated: November 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–28442 Filed 11–25–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1064] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program AGENCY: Food and Drug Administration, HHS. ACTION: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0551. Also include the FDA 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, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. ADDRESSES: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by December 28, 2016. SUMMARY: Application for Participation in the Medical Device Fellowship Program— OMB Control Number 0910–0551— Extension Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of Title 5 of the United States Code authorize Federal Agencies to rate applicants for Federal jobs. Collecting applications for the Medical Device Fellowship Program will allow FDA’s Center for Devices and Radiological Health (CDRH) to easily and efficiently elicit and review information from students and health care professionals who are interested in becoming involved in CDRH activities. The process will reduce the time and cost of submitting written documentation to the Agency and lessen the likelihood of applications being misrouted within the Agency mail system. It will assist the Agency in promoting and protecting the public health by encouraging outside persons to share their expertise with CDRH. In the Federal Register of September 6, 2016 (81 FR 61221), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: mstockstill on DSK3G9T082PROD with NOTICES TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 Number of respondents FDA Form Application Form (FDA 3608) .............................................. 1 There Number of responses per respondent 250 Total annual responses 1 250 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Sep<11>2014 21:15 Nov 25, 2016 Jkt 241001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\28NON1.SGM 28NON1 Average burden per response Total hours 1 250 85580 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Notices Dated: November 21, 2016. Leslie Kux, Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Service Administration [FR Doc. 2016–28443 Filed 11–25–16; 8:45 am] BILLING CODE 4164–01–P Advisory Committee on Interdisciplinary, Community-Based Linkages DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Service Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice of meeting. AGENCY: Food and Drug Administration [Docket No. FDA–2011–N–0769] Notice of Listing of Members of the Food and Drug Administration’s Performance Review Board AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the names of the members who will serve on its Performance Review Board (PRB). The purpose of the PRB is to provide fair and impartial review of senior executive service (SES), senior professional and Title 42 SES Equivalents performance appraisals, bonus recommendations, and pay adjustments. SUMMARY: DATES: Effective November 7, 2016. Abu Sesay, Office of Human Resources Executive and Resources Management Staff, Food and Drug Administration, Three White Flint North, 05D04, 11601 Landsdown St., North Bethesda, MD 20852, 240–402–0440, abu.sesay@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: This action is being taken pursuant to 5 U.S.C. 4314(c)(4), which requires that members of performance review boards be appointed in a manner to ensure consistency, stability, and objectivity in performance appraisals and requires that notice of the appointment of an individual to serve as a member be published in the Federal Register. The following persons will serve on FDA’s Performance Review Board, which oversees the evaluation of performance appraisals of FDA’s senior executives: James Sigg, PRB Chair and member; Tania Tse, PRB Officiator; Glenda Barfell; Vincent Bunning; Mary Beth Clarke; Tracey Forfa; Leslie Kux; Deanna Murphy; Lynne Rice; and Richard Turman. mstockstill on DSK3G9T082PROD with NOTICES SUPPLEMENTARY INFORMATION: Dated: November 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–28452 Filed 11–25–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 21:15 Nov 25, 2016 Jkt 241001 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given that a meeting is scheduled for Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). This meeting will be open to the public. Information about the ACICBL and the agenda for this meeting can be obtained by accessing the following Web site: http:// www.hrsa.gov/advisorycommittees/ bhpradvisory/acicbl/index.html. The agenda will be available 2 days prior to the meeting on the HRSA Web site listed above. DATES: The meeting will be held on December 8, 2016 (10:00 a.m.–4:00 p.m.). SUMMARY: This meeting will be held via webinar and teleconference. Webinar information can be found on the Web site at: https:// hrsa.connectsolutions.com/acicbl and below. • The conference call-in number is 1– 800–619–2521. The passcode is: 9271697. • The Webinar link is https:// hrsa.connectsolutions.com/acicbl. FOR FURTHER INFORMATION CONTACT: Anyone requesting information regarding the ACICBL should contact Dr. Joan Weiss, Designated Federal Official, within the Bureau of Health Workforce, Health Resources and Services Administration, in one of three ways: (1) Send a request to the following address: Dr. Joan Weiss, Designated Federal Official, Bureau of Health Workforce, Health Resources and Services Administration, 5600 Fishers Lane, Room 15N39, Rockville, Maryland 20857; (2) call (301) 443–0430; or (3) send an email to jweiss@hrsa.gov. SUPPLEMENTARY INFORMATION: The ACICBL provides advice and recommendations to the Secretary of HHS (Secretary) concerning policy, program development, and other matters of significance related to interdisciplinary, community-based training grant programs authorized ADDRESSES: PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 under sections 750–759, Title VII, Part D of the Public Health Service (PHS) Act, as amended by the Affordable Care Act. The following sections of the PHS Act are included under Part D: 751— Area Health Education Centers; 752— Continuing Educational Support for Health Professionals Serving in Underserved Communities; 753— Geriatrics Workforce Enhancement; 754—Quentin N. Burdick Program for Rural Interdisciplinary Training; 755— Allied Health and Other Disciplines; 756—Mental and Behavioral Health Education and Training, and 759— Program for Education and Training in Pain Care. Per the PHS Act section 757(d)(2), the Committee is responsible for publishing an annual report describing ‘‘the activities of the Committee, including findings and recommendations made by the Committee concerning the activities under this part.’’ The members of the ACICBL will discuss how they would like to proceed with and structure the statutorily mandated 17th report. They will also finalize the statutorily mandated 16th Annual Report to the Secretary and Congress on ‘‘Enhancing Community-Based Training Sites: Challenges and Opportunities.’’ Members of the public will have the opportunity to provide comments. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to make oral comments or provide written comments to the ACICBL should be sent to Dr. Joan Weiss, Designated Federal Official, using the address and phone number above at least 3 days prior to the meeting. Jason E. Bennett, Director, Division of the Executive Secretariat. [FR Doc. 2016–28469 Filed 11–25–16; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Decision To Evaluate a Petition To Designate a Class of Employees From Metals & Controls Corp. in Attleboro, Massachusetts, To Be Included in the Special Exposure Cohort National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services. ACTION: Notice. AGENCY: NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from Metals & Controls Corp. in Attleboro, SUMMARY: E:\FR\FM\28NON1.SGM 28NON1

Agencies

[Federal Register Volume 81, Number 228 (Monday, November 28, 2016)]
[Notices]
[Pages 85579-85580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28443]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1064]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Application for 
Participation in the Medical Device Fellowship Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 28, 2016.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0551. 
Also include the FDA 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, Three White Flint North 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.
Application for Participation in the Medical Device Fellowship 
Program--OMB Control Number 0910-0551--Extension
    Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of 
Title 5 of the United States Code authorize Federal Agencies to rate 
applicants for Federal jobs. Collecting applications for the Medical 
Device Fellowship Program will allow FDA's Center for Devices and 
Radiological Health (CDRH) to easily and efficiently elicit and review 
information from students and health care professionals who are 
interested in becoming involved in CDRH activities. The process will 
reduce the time and cost of submitting written documentation to the 
Agency and lessen the likelihood of applications being misrouted within 
the Agency mail system. It will assist the Agency in promoting and 
protecting the public health by encouraging outside persons to share 
their expertise with CDRH.
    In the Federal Register of September 6, 2016 (81 FR 61221), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            FDA Form                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Application Form (FDA 3608).....             250               1             250               1             250
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



[[Page 85580]]

    Dated: November 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28443 Filed 11-25-16; 8:45 am]
 BILLING CODE 4164-01-P