81 FR 52439 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Alumni Commissioner's Fellowship Program Fellows
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 152 (August 8, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 152 (August 8, 2016)
| Page Range | 52439-52440 | |
| FR Document | 2016-18711 |
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)] [Notices] [Pages 52439-52440] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18711] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0566] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Alumni Commissioner's Fellowship Program Fellows 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 [[Page 52440]] (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by September 7, 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 title Outcomes Evaluation Survey for Graduates of the FDA Commissioner's Fellowship Program. 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, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [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. Survey of Alumni Commissioner's Fellowship Program Fellows--OMB Control Number 0910-NEW FDA is requesting approval from the Office of Management and Budget to gather information from Alumni Commissioner's Fellowship Program (CFP) Fellows. The information from Alumni CFP Fellows will allow FDA's Office of the Commissioner (OC) to easily and efficiently elicit and review program feedback. The online survey will assist the Agency in promoting and protecting the public health by encouraging outside persons to share their experience with the FDA while a Commissioner's Fellow. The process will reduce the time and cost of submitting written documentation to the Agency and lessen the likelihood of surveys being misrouted within the Agency mail system. The information gathered by the survey will be used to gain insights into, and to document, impacts that the CFP has had and is having on former CFP fellows and contributions and impacts that the former fellows are making in their current work. The surveys include questions to assess the following measures: Post-fellowship employment (e.g., employment type); number of awards; number of contributions while a CFP fellow (e.g., number of publications, guidances authored or co-authored); and contributions in their field (e.g., list of publications). In the Federal Register of February 24, 2016 (81 FR 9202), 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 Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Fellowship Program Survey................... 35 1 35 0.50 (30 minutes)......................... 17.5 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating maintenance costs associated with this collection of information. FDA based these estimates on the number of fellows that have graduated and left the Agency over the past 5 years. Dated: August 2, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-18711 Filed 8-5-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices 52439
review and clearance. The Federal tested NAMRS. When implemented, Proposed Collection Effort: NAMRS
Register notice that solicited public NAMRS will be the first comprehensive, has been developed as a voluntary
comment on the information collection national reporting system for APS system to collect annually both
for a period of 60 days was published programs. NAMRS is intended to collect summary and de-identified case-level
on March 22, 2016. quantitative and qualitative data on the data on APS investigations. NAMRS
Authority: This data collection effort practices and policies of adult consists of three components:
is in response to the Elder Justice Act of protective services (APS) agencies, as (1) ACL proposes to collect descriptive
2009, which amended title XX of the well as the outcomes of investigations data on state agency policies and practices
Social Security Act (42.U.S.C. 13976 et into the maltreatment of older adults from all states through the ‘‘Agency
seq.). These provisions require that the and adults with disabilities. In Component,’’ and
Secretary of HHS ‘‘collects and developing NAMRS, ACL and ASPE (2) Case-level, non-identifiable data on
disseminates data annually relating to convened key stakeholders to identify persons who receive an investigation by APS
in response to an allegation of abuse, neglect,
the abuse, exploitation, and neglect of data elements that are the most critical or exploitation through the ‘‘Case
elders in coordination with the for a national system. More than 40 state Component.’’
Department of Justice’’ (Sec. administrators, researchers, service (3) For states that are unable to submit a
2041(a)(1)(B)), and ‘‘conducts research providers, and other stakeholders case-level file through the ‘‘Case
related to the provision of adult provided input in focus group Component,’’ a ‘‘Key Indicators Component’’
protective services’’ (Sec. 2041(a)(1)(D)). conference calls. Additionally, more will be available for them to submit data on
Furthermore, the Elder Justice than 30 state representatives from 25 a smaller set of core items.
Coordinating Council (EJCC) included different states met in three in-person ACL will provide technical assistance
as its third recommendation for working sessions to discuss the uses of to states to assist in the preparation of
increasing federal involvement in collected data and the key their data submissions. Respondents
addressing elder abuse, neglect, and functionalities. A pilot version of will be state APS agencies and APS
exploitation: Develop a national adult NAMRS was tested in nine (9) diverse agencies in the District of Columbia,
protective services (APS) system based states, and refined based on feedback Puerto Rico, Guam, Northern Marianas
upon standardized data collection and a from the pilot and additional Islands, Virgin Islands, and American
core set of service provision standards stakeholder engagement. A full Samoa. No personally identifiable
and best practices. discussion on the background of information will be collected. ACL has
Background: From 2013–2015, ACL, NAMRS, including the development of calculated the following burden
in partnership with the U.S. Department the system, the public engagement estimates (information on how the
of Health & Human Services’ Office of process, and the pilot testing can be estimates were calculated is available in
the Assistant Secretary for Planning and found in the NAMRS section of the ACL the NAMRS section of the ACL Web
Evaluation (ASPE), developed and pilot Web site. site):
Number of Average
Number of responses Total burden
Instrument burden hours
respondents per hours
per response
respondent
Agency Component ......................................................................................... 56 1 13 728
Key Indicators Component .............................................................................. 31 1 40 1,240
Case Component ............................................................................................. 25 1 150 3,750
Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 5,718
OMB is required to make a decision including whether the information shall have DEPARTMENT OF HEALTH AND
concerning the collection of information practical utility; HUMAN SERVICES
between 30 and 60 days after (b) the accuracy of the agency’s estimate of
publication of this document in the the burden of the proposed collection of Food and Drug Administration
information;
Federal Register. Therefore, a comment (c) the quality, utility, and clarity of the
is best assured of having its full effect information to be collected; and [Docket No. FDA–2016–N–0566]
if OMB receives it within 30 days of (d) ways to minimize the burden of the
publication of this announcement. collection of information on respondents, Agency Information Collection
Written comments and including through the use of automated Activities; Submission for Office of
recommendations for the proposed collection techniques or other forms of Management and Budget Review;
information collection should be sent information technology. Comment Request; Survey of Alumni
directly to the following address: Office Consideration will be given to Commissioner’s Fellowship Program
of Management and Budget, Paperwork comments and suggestions submitted Fellows
Reduction Project, email: OIRA_ within 30 days of this publication. The
Submission@OMB.EOP.GOV; Attention: AGENCY: Food and Drug Administration,
proposed collection of information tools
Desk Officer for the Administration for HHS.
mstockstill on DSK3G9T082PROD with NOTICES
may be found in the NAMRS section of
Community Living. the ACL Web site. ACTION: Notice.
With respect to the collection of
information via NAMRS, ACL Dated: August 2, 2016.
SUMMARY: The Food and Drug
specifically requests comments on: Edwin L. Walker, Administration (FDA) is announcing
Acting Assistant Secretary for Aging. that a proposed collection of
(a) Whether the proposed collection of
information is necessary for the proper [FR Doc. 2016–18731 Filed 8–5–16; 8:45 am] information has been submitted to the
performance of the functions of the agency, BILLING CODE 4154–01–P Office of Management and Budget
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![52440 Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Notices
(OMB) for review and clearance under SUPPLEMENTARY INFORMATION: In surveys being misrouted within the
the Paperwork Reduction Act of 1995. compliance with 44 U.S.C. 3507, FDA Agency mail system. The information
DATES: Fax written comments on the has submitted the following proposed gathered by the survey will be used to
collection of information by September collection of information to OMB for gain insights into, and to document,
7, 2016. review and clearance. impacts that the CFP has had and is
ADDRESSES: To ensure that comments on Survey of Alumni Commissioner’s having on former CFP fellows and
the information collection are received, Fellowship Program Fellows—OMB contributions and impacts that the
OMB recommends that written Control Number 0910–NEW former fellows are making in their
comments be faxed to the Office of current work. The surveys include
FDA is requesting approval from the questions to assess the following
Information and Regulatory Affairs, Office of Management and Budget to
OMB, Attn: FDA Desk Officer, FAX: measures: Post-fellowship employment
gather information from Alumni (e.g., employment type); number of
202–395–7285, or emailed to oira_ Commissioner’s Fellowship Program
submission@omb.eop.gov. All awards; number of contributions while
(CFP) Fellows. The information from a CFP fellow (e.g., number of
comments should be identified with the Alumni CFP Fellows will allow FDA’s
title Outcomes Evaluation Survey for publications, guidances authored or co-
Office of the Commissioner (OC) to authored); and contributions in their
Graduates of the FDA Commissioner’s easily and efficiently elicit and review
Fellowship Program. Also include the field (e.g., list of publications).
program feedback. The online survey
FDA docket number found in brackets will assist the Agency in promoting and In the Federal Register of February
in the heading of this document. protecting the public health by 24, 2016 (81 FR 9202), FDA published
FOR FURTHER INFORMATION CONTACT: FDA encouraging outside persons to share a 60-day notice requesting public
PRA Staff, Office of Operations, Food their experience with the FDA while a comment on the proposed collection of
and Drug Administration, 8455 Commissioner’s Fellow. The process information. No comments were
Colesville Rd., COLE–14526, Silver will reduce the time and cost of received.
Spring, MD 20993–0002, PRAStaff@ submitting written documentation to the FDA estimates the burden of this
fda.hhs.gov. Agency and lessen the likelihood of collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
Activity responses per Total hours
respondents responses response
respondent
Fellowship Program Survey ..................................... 35 1 35 0.50 (30 minutes) ...... 17.5
1 There are no capital costs or operating maintenance costs associated with this collection of information.
FDA based these estimates on the effectiveness. This determination means ANDA applicants do not have to repeat
number of fellows that have graduated that FDA will not begin procedures to the extensive clinical testing otherwise
and left the Agency over the past 5 withdraw approval of abbreviated new necessary to gain approval of a new
years. drug applications (ANDAs) that refer to drug application (NDA).
Dated: August 2, 2016. these drug products, and it will allow The 1984 amendments include what
Leslie Kux,
FDA to continue to approve ANDAs that is now section 505(j)(7) of the Federal
refer to the products as long as they Food, Drug, and Cosmetic Act (21 U.S.C.
Associate Commissioner for Policy.
meet relevant legal and regulatory 355(j)(7)), which requires FDA to
[FR Doc. 2016–18711 Filed 8–5–16; 8:45 am]
requirements. publish a list of all approved drugs.
BILLING CODE 4164–01–P
FDA publishes this list as part of the
FOR FURTHER INFORMATION CONTACT:
‘‘Approved Drug Products With
Stacy Kane, Center for Drug Evaluation
DEPARTMENT OF HEALTH AND Therapeutic Equivalence Evaluations,’’
and Research, Food and Drug
HUMAN SERVICES which is generally known as the
Administration, 10903 New Hampshire
‘‘Orange Book.’’ Under FDA regulations,
Ave., Bldg. 51, Rm. 6207, Silver Spring,
Food and Drug Administration a drug is removed from the list if the
MD 20993–0002, 301–796–8363,
Agency withdraws or suspends
[Docket No. FDA–2016–N–2062] Stacy.Kane@fda.hhs.gov.
approval of the drug’s NDA or ANDA
SUPPLEMENTARY INFORMATION: In 1984, for reasons of safety or effectiveness, or
Determination That BENTYL if FDA determines that the listed drug
Congress enacted the Drug Price
(Dicyclomine Hydrochloride) Syrup was withdrawn from sale for reasons of
Competition and Patent Term
and Other Drug Products Were Not safety or effectiveness (21 CFR 314.162).
Restoration Act of 1984 (Pub. L. 98–417)
Withdrawn From Sale for Reasons of
(the 1984 amendments), which Under § 314.161(a) (21 CFR
Safety or Effectiveness
authorized the approval of duplicate 314.161(a)), the Agency must determine
AGENCY: Food and Drug Administration, versions of drug products approved whether a listed drug was withdrawn
HHS. under an ANDA procedure. ANDA from sale for reasons of safety or
mstockstill on DSK3G9T082PROD with NOTICES
ACTION: Notice. applicants must, with certain effectiveness: (1) Before an ANDA that
exceptions, show that the drug for refers to that listed drug may be
SUMMARY: The Food and Drug which they are seeking approval approved, (2) whenever a listed drug is
Administration (FDA or Agency) has contains the same active ingredient in voluntarily withdrawn from sale and
determined that the drug products listed the same strength and dosage form as ANDAs that refer to the listed drug have
in this document were not withdrawn the ‘‘listed drug,’’ which is a version of been approved, and (3) when a person
from sale for reasons of safety or the drug that was previously approved. petitions for such a determination under
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Document Created: 2016-08-06 03:07:53
Document Modified: 2016-08-06 03:07:53
| 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 September 7, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 52439 |
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