81 FR 85579 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in the Medical Device Fellowship Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 228 (November 28, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 228 (November 28, 2016)
| Page Range | 85579-85580 | |
| FR Document | 2016-28443 |
[Federal Register Volume 81, Number 228 (Monday, November 28, 2016)] [Notices] [Pages 85579-85580] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28443] ----------------------------------------------------------------------- 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 [email protected]. 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, [email protected]. 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
![Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Notices 85579
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 Fiscal year of PMC establishment
FY2015
(% of total PMCs in
each establishment 2009 2010 2011 2012 2013 2014 2015
year)
Delayed ........................ 6 (13%) 12 (13%) 8 (10%) 6 (13%) 4 (9%) 0 0
Terminated ................... 1 (2%) 0 0 0 0 0 0
Released ...................... 4 (8%) 7 (7%) 10 (12%) 1 (2%) 1 (2%) 0 1 (2%)
Fulfilled ......................... 30 (63%) 44 (47%) 35 (43%) 22 (48%) 14 (30%) 10 (16%) 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. ADDRESSES: To ensure that comments on Federal jobs. Collecting applications for
Leslie Kux, the information collection are received, the Medical Device Fellowship Program
Associate Commissioner for Policy. OMB recommends that written will allow FDA’s Center for Devices and
[FR Doc. 2016–28442 Filed 11–25–16; 8:45 am] comments be faxed to the Office of Radiological Health (CDRH) to easily
BILLING CODE 4164–01–P Information and Regulatory Affairs, and efficiently elicit and review
OMB, Attn: FDA Desk Officer, FAX: information from students and health
202–395–7285, or emailed to oira_ care professionals who are interested in
DEPARTMENT OF HEALTH AND submission@omb.eop.gov. All becoming involved in CDRH activities.
HUMAN SERVICES comments should be identified with the The process will reduce the time and
OMB control number 0910–0551. Also cost of submitting written
Food and Drug Administration include the FDA docket number found documentation to the Agency and lessen
[Docket No. FDA–2013–N–1064] in brackets in the heading of this the likelihood of applications being
document.
misrouted within the Agency mail
Agency Information Collection FOR FURTHER INFORMATION CONTACT: FDA system. It will assist the Agency in
Activities; Submission for Office of PRA Staff, Office of Operations, Food promoting and protecting the public
Management and Budget Review; and Drug Administration, Three White
Comment Request; Application for health by encouraging outside persons
Flint North 10A63, 11601 Landsdown to share their expertise with CDRH.
Participation in the Medical Device St., North Bethesda, MD 20852,
Fellowship Program PRAStaff@fda.hhs.gov. In the Federal Register of September
6, 2016 (81 FR 61221), FDA published
AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA a 60-day notice requesting public
HHS.
has submitted the following proposed comment on the proposed collection of
ACTION: Notice.
collection of information to OMB for information. No comments were
SUMMARY: The Food and Drug review and clearance. received.
Administration (FDA) is announcing FDA estimates the burden of this
that a proposed collection of Application for Participation in the
collection of information as follows:
information has been submitted to the Medical Device Fellowship Program—
Office of Management and Budget OMB Control Number 0910–0551—
(OMB) for review and clearance under Extension
the Paperwork Reduction Act of 1995. Sections 1104, 1302, 3301, 3304,
DATES: Fax written comments on the 3320, 3361, 3393, and 3394 of Title 5 of
collection of information by December the United States Code authorize
28, 2016. Federal Agencies to rate applicants for
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of Average
Number of Total annual
mstockstill on DSK3G9T082PROD with NOTICES
FDA Form responses per burden per Total hours
respondents responses
respondent 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.
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](https://thefederalregister.org/doc/81_FR_85807/page/1.svg)
![85580 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Notices
Dated: November 21, 2016. DEPARTMENT OF HEALTH AND under sections 750–759, Title VII, Part
Leslie Kux, HUMAN SERVICES D of the Public Health Service (PHS)
Associate Commissioner for Policy. Act, as amended by the Affordable Care
[FR Doc. 2016–28443 Filed 11–25–16; 8:45 am] Health Resources and Service Act. The following sections of the PHS
BILLING CODE 4164–01–P
Administration Act are included under Part D: 751—
Area Health Education Centers; 752—
Advisory Committee on Continuing Educational Support for
DEPARTMENT OF HEALTH AND Interdisciplinary, Community-Based Health Professionals Serving in
HUMAN SERVICES Linkages Underserved Communities; 753—
AGENCY: Health Resources and Service Geriatrics Workforce Enhancement;
Food and Drug Administration Administration (HRSA), Department of 754—Quentin N. Burdick Program for
Health and Human Services (HHS). Rural Interdisciplinary Training; 755—
[Docket No. FDA–2011–N–0769] Allied Health and Other Disciplines;
ACTION: Notice of meeting.
756—Mental and Behavioral Health
Notice of Listing of Members of the SUMMARY: In accordance with section Education and Training, and 759—
Food and Drug Administration’s 10(a)(2) of the Federal Advisory Program for Education and Training in
Performance Review Board Committee Act (Pub. L. 92–463), notice Pain Care.
is hereby given that a meeting is Per the PHS Act section 757(d)(2), the
AGENCY: Food and Drug Administration, Committee is responsible for publishing
HHS. scheduled for Advisory Committee on
an annual report describing ‘‘the
Interdisciplinary, Community-Based
ACTION: Notice. activities of the Committee, including
Linkages (ACICBL). This meeting will
findings and recommendations made by
SUMMARY: The Food and Drug be open to the public. Information about
the Committee concerning the activities
Administration (FDA) is announcing the the ACICBL and the agenda for this
under this part.’’ The members of the
names of the members who will serve meeting can be obtained by accessing
ACICBL will discuss how they would
on its Performance Review Board (PRB). the following Web site: http://
like to proceed with and structure the
The purpose of the PRB is to provide www.hrsa.gov/advisorycommittees/
statutorily mandated 17th report. They
fair and impartial review of senior bhpradvisory/acicbl/index.html. The
will also finalize the statutorily
executive service (SES), senior agenda will be available 2 days prior to
mandated 16th Annual Report to the
professional and Title 42 SES the meeting on the HRSA Web site
Secretary and Congress on ‘‘Enhancing
Equivalents performance appraisals, listed above.
Community-Based Training Sites:
bonus recommendations, and pay DATES: The meeting will be held on Challenges and Opportunities.’’
adjustments. December 8, 2016 (10:00 a.m.–4:00 Members of the public will have the
p.m.). opportunity to provide comments. Oral
DATES: Effective November 7, 2016.
ADDRESSES: This meeting will be held comments will be honored in the order
FOR FURTHER INFORMATION CONTACT: Abu
via webinar and teleconference. they are requested and may be limited
Sesay, Office of Human Resources
Webinar information can be found on as time allows. Requests to make oral
Executive and Resources Management
the Web site at: https:// comments or provide written comments
Staff, Food and Drug Administration,
hrsa.connectsolutions.com/acicbl and to the ACICBL should be sent to Dr. Joan
Three White Flint North, 05D04, 11601
below. Weiss, Designated Federal Official,
Landsdown St., North Bethesda, MD
20852, 240–402–0440, abu.sesay@ • The conference call-in number is 1– using the address and phone number
800–619–2521. The passcode is: above at least 3 days prior to the
fda.hhs.gov.
9271697. meeting.
SUPPLEMENTARY INFORMATION: This • The Webinar link is https:// Jason E. Bennett,
action is being taken pursuant to 5 hrsa.connectsolutions.com/acicbl.
U.S.C. 4314(c)(4), which requires that Director, Division of the Executive Secretariat.
FOR FURTHER INFORMATION CONTACT: [FR Doc. 2016–28469 Filed 11–25–16; 8:45 am]
members of performance review boards
Anyone requesting information
be appointed in a manner to ensure BILLING CODE 4165–15–P
regarding the ACICBL should contact
consistency, stability, and objectivity in
Dr. Joan Weiss, Designated Federal
performance appraisals and requires
Official, within the Bureau of Health DEPARTMENT OF HEALTH AND
that notice of the appointment of an
Workforce, Health Resources and HUMAN SERVICES
individual to serve as a member be
Services Administration, in one of three
published in the Federal Register. Decision To Evaluate a Petition To
ways: (1) Send a request to the following
The following persons will serve on Designate a Class of Employees From
address: Dr. Joan Weiss, Designated
FDA’s Performance Review Board, Metals & Controls Corp. in Attleboro,
Federal Official, Bureau of Health
which oversees the evaluation of Massachusetts, To Be Included in the
Workforce, Health Resources and
performance appraisals of FDA’s senior Special Exposure Cohort
Services Administration, 5600 Fishers
executives: James Sigg, PRB Chair and
Lane, Room 15N39, Rockville, Maryland
member; Tania Tse, PRB Officiator; AGENCY: National Institute for
20857; (2) call (301) 443–0430; or (3)
Glenda Barfell; Vincent Bunning; Mary Occupational Safety and Health
send an email to jweiss@hrsa.gov.
Beth Clarke; Tracey Forfa; Leslie Kux; (NIOSH), Centers for Disease Control
SUPPLEMENTARY INFORMATION: The
mstockstill on DSK3G9T082PROD with NOTICES
Deanna Murphy; Lynne Rice; and and Prevention, Department of Health
Richard Turman. ACICBL provides advice and and Human Services.
recommendations to the Secretary of ACTION: Notice.
Dated: November 21, 2016. HHS (Secretary) concerning policy,
Leslie Kux, program development, and other SUMMARY: NIOSH gives notice of a
Associate Commissioner for Policy. matters of significance related to decision to evaluate a petition to
[FR Doc. 2016–28452 Filed 11–25–16; 8:45 am] interdisciplinary, community-based designate a class of employees from
BILLING CODE 4164–01–P training grant programs authorized Metals & Controls Corp. in Attleboro,
VerDate Sep<11>2014 21:15 Nov 25, 2016 Jkt 241001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\28NON1.SGM 28NON1](https://thefederalregister.org/doc/81_FR_85807/page/2.svg)
Document Created: 2018-02-14 08:35:59
Document Modified: 2018-02-14 08:35:59
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by December 28, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 85579 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR