82_FR_58447 82 FR 58211 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in Food and Drug Administration Fellowship Programs

82 FR 58211 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in Food and Drug Administration Fellowship Programs

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 236 (December 11, 2017)

Page Range58211-58212
FR Document2017-26543

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.

Federal Register, Volume 82 Issue 236 (Monday, December 11, 2017)
[Federal Register Volume 82, Number 236 (Monday, December 11, 2017)]
[Notices]
[Pages 58211-58212]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26543]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1072]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Application for 
Participation in Food and Drug Administration Fellowship Programs

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 January 
10, 2018.

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 0910-0780. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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 FDA Fellowship Programs (Formerly 
Application for Participation in the FDA Commissioner's Fellowship 
Program)--OMB Control Number 0910-0780--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. The proposed information collection 
involves brief online applications completed by applicants applying to 
FDA's fellowship programs. These voluntary online applications will 
allow the Agency to easily and efficiently elicit and review 
information from students and healthcare professionals who are 
interested in becoming involved in FDA-wide 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 FDA.
    In the Federal Register of June 20, 2017 (82 FR 28075), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it wasn't 
responsive to the four collection of information topics solicited and 
therefore will not be discussed in this document.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Commissioner's Fellowship                    600               1             600            1.33             798
 Program........................
Regulatory Science Internship                250               1             250               1             250
 Program........................
Medical Device Fellowship                    250               1             250               1             250
 Program........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,298
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



[[Page 58212]]

    Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26543 Filed 12-8-17; 8:45 am]
 BILLING CODE 4164-01-P



                                                                                   Federal Register / Vol. 82, No. 236 / Monday, December 11, 2017 / Notices                                                                                                  58211

                                                                                                                                    ANNUAL BURDEN ESTIMATES
                                                                                                                                                                                                     Number of                   Average
                                                                                                                                                                          Number of                                                                      Total burden
                                                                                                Instrument                                                                                         responses per               burden hours
                                                                                                                                                                         respondents                                                                        hours
                                                                                                                                                                                                     respondent                per response

                                               Case Plan ........................................................................................................            544,098                         1                        4.80                2,626,436



                                                 Estimated Total Annual Burden                                            DEPARTMENT OF HEALTH AND                                                     SUPPLEMENTARY INFORMATION:    In
                                               Hours: 2,626,436.                                                          HUMAN SERVICES                                                               compliance with 44 U.S.C. 3507, FDA
                                                 Additional Information: Copies of the                                                                                                                 has submitted the following proposed
                                                                                                                          Food and Drug Administration                                                 collection of information to OMB for
                                               proposed collection may be obtained by
                                               writing to the Administration for                                          [Docket No. FDA–2014–N–1072]                                                 review and clearance.
                                               Children and Families, Office of                                                                                                                        Application for Participation in FDA
                                               Planning, Research and Evaluation, 330                                     Agency Information Collection                                                Fellowship Programs (Formerly
                                                                                                                          Activities; Submission for Office of                                         Application for Participation in the
                                               C Street SW., Washington, DC 20201.
                                                                                                                          Management and Budget Review;                                                FDA Commissioner’s Fellowship
                                               Attention Reports Clearance Officer. All
                                                                                                                          Comment Request; Application for                                             Program)—OMB Control Number 0910–
                                               requests should be identified by the title                                 Participation in Food and Drug
                                               of the information collection. Email                                                                                                                    0780—Extension
                                                                                                                          Administration Fellowship Programs
                                               address: infocollection@acf.hhs.gov.                                                                                                                       Sections 1104, 1302, 3301, 3304,
                                                                                                                          AGENCY:           Food and Drug Administration,
                                                 OMB Comment: OMB is required to                                                                                                                       3320, 3361, 3393, and 3394 of Title 5 of
                                                                                                                          HHS.
                                               make a decision concerning the                                                                                                                          the United States Code authorize
                                               collection of information between 30                                       ACTION:       Notice.
                                                                                                                                                                                                       Federal agencies to rate applicants for
                                               and 60 days after publication of this                                      SUMMARY:   The Food and Drug                                                 Federal jobs. The proposed information
                                               document in the Federal Register.                                          Administration (FDA) is announcing                                           collection involves brief online
                                               Therefore, a comment is best assured of                                    that a proposed collection of                                                applications completed by applicants
                                               having its full effect if OMB receives it                                  information has been submitted to the                                        applying to FDA’s fellowship programs.
                                               within 30 days of publication. Written                                     Office of Management and Budget                                              These voluntary online applications
                                               comments and recommendations for the                                       (OMB) for review and clearance under                                         will allow the Agency to easily and
                                               proposed information collection should                                     the Paperwork Reduction Act of 1995.                                         efficiently elicit and review information
                                               be sent directly to the following: Office                                  DATES: Fax written comments on the                                           from students and healthcare
                                               of Management and Budget, Paperwork                                        collection of information by January 10,                                     professionals who are interested in
                                               Reduction Project, Email: OIRA_                                            2018.                                                                        becoming involved in FDA-wide
                                               SUBMISSION@OMB.EOP.GOV. Attn:                                              ADDRESSES: To ensure that comments on                                        activities. The process will reduce the
                                                                                                                          the information collection are received,                                     time and cost of submitting written
                                               Desk Officer for the Administration for
                                                                                                                          OMB recommends that written                                                  documentation to the Agency and lessen
                                               Children and Families.
                                                                                                                          comments be faxed to the Office of                                           the likelihood of applications being
                                               Robert Sargis,                                                             Information and Regulatory Affairs,                                          misrouted within the Agency mail
                                               Reports Clearance Officer.                                                 OMB, Attn: FDA Desk Officer, Fax: 202–                                       system. It will assist the Agency in
                                               [FR Doc. 2017–26553 Filed 12–8–17; 8:45 am]                                395–7285, or emailed to oira_                                                promoting and protecting the public
                                                                                                                          submission@omb.eop.gov. All                                                  health by encouraging outside persons
                                               BILLING CODE 4184–25–P
                                                                                                                          comments should be identified with the                                       to share their expertise with FDA.
                                                                                                                          OMB control number 0910–0780. Also                                              In the Federal Register of June 20,
                                                                                                                          include the FDA docket number found                                          2017 (82 FR 28075), FDA published a
                                                                                                                          in brackets in the heading of this                                           60-day notice requesting public
                                                                                                                          document.                                                                    comment on the proposed collection of
                                                                                                                          FOR FURTHER INFORMATION CONTACT:                                             information. Although one comment
                                                                                                                          Amber Sanford, Office of Operations,                                         was received, it wasn’t responsive to the
                                                                                                                          Food and Drug Administration, Three                                          four collection of information topics
                                                                                                                          White Flint North, 10A–12M, 11601                                            solicited and therefore will not be
                                                                                                                          Landsdown St., North Bethesda, MD                                            discussed in this document.
                                                                                                                          20852, 301–796–8867, PRAStaff@                                                  FDA estimates the burden of this
                                                                                                                          fda.hhs.gov.                                                                 collection of information as follows:

                                                                                                        TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
                                                                                                                                                                          Number of                                                Average
                                                                                                                                               Number of                                            Total annual
                                                                                      Activity                                                                          responses per                                            burden per              Total hours
                                                                                                                                              respondents                                            responses
                                                                                                                                                                          respondent                                              response
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                                               Commissioner’s Fellowship Program ..................................                                           600                            1                       600                       1.33               798
                                               Regulatory Science Internship Program ..............................                                           250                            1                       250                          1               250
                                               Medical Device Fellowship Program ...................................                                          250                            1                       250                          1               250

                                                     Total ..............................................................................    ........................   ........................   ........................   ........................          1,298
                                                  1 There     are no capital costs or operating and maintenance costs associated with this collection of information.



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                                               58212                                Federal Register / Vol. 82, No. 236 / Monday, December 11, 2017 / Notices

                                                 Dated: December 5, 2017.                                                  FOR FURTHER INFORMATION CONTACT:                                            Protections is requesting an extension
                                               Leslie Kux,                                                                 When submitting comments or                                                 on a currently approved information
                                               Associate Commissioner for Policy.                                          requesting information, please include                                      collection by the Office of Management
                                               [FR Doc. 2017–26543 Filed 12–8–17; 8:45 am]                                 the document identifier 0990-New–60D                                        and Budget, OMB, on the Protection of
                                               BILLING CODE 4164–01–P
                                                                                                                           and project title for reference., to                                        Human Subjects: Assurance
                                                                                                                           Sherrette.funn@hhs.gov, or call the                                         Identification/IRB Certification/
                                                                                                                           Reports Clearance Officer.                                                  Declaration of Exemption Form. That
                                               DEPARTMENT OF HEALTH AND                                                    SUPPLEMENTARY INFORMATION: Interested                                       form is designed to provide a simplified
                                               HUMAN SERVICES                                                              persons are invited to send comments                                        procedure for institutions engaged in
                                                                                                                           regarding this burden estimate or any                                       research conducted or supported by the
                                               [Document Identifier: OS–0990–0263]
                                                                                                                           other aspect of this collection of                                          Department of Health and Human
                                               Agency Information Collection                                               information, including any of the                                           Services (HHS) to satisfy the
                                               Request; 60-Day Public Comment                                              following subjects: (1) The necessity and                                   requirements of HHS regulations for the
                                               Request                                                                     utility of the proposed information                                         protection of human subjects at 45 CFR
                                                                                                                           collection for the proper performance of                                    46.103. The respondents for this
                                               AGENCY:      Office of the Secretary, HHS.                                  the agency’s functions; (2) the accuracy                                    collection are institutions engaged in
                                               ACTION:      Notice.                                                        of the estimated burden; (3) ways to                                        research involving human subjects
                                                                                                                           enhance the quality, utility, and clarity                                   where the research is supported by
                                               SUMMARY:   In compliance with the                                           of the information to be collected; and
                                               requirement of the Paperwork                                                                                                                            HHS. Institutional use of the form is
                                                                                                                           (4) the use of automated collection                                         also relied upon by other federal
                                               Reduction Act of 1995, the Office of the                                    techniques or other forms of information
                                               Secretary (OS), Department of Health                                                                                                                    departments and agencies that have
                                                                                                                           technology to minimize the information
                                               and Human Services, is publishing the                                                                                                                   codified or follow the Federal Policy for
                                                                                                                           collection burden. Information
                                               following summary of a proposed                                                                                                                         the Protection of Human Subjects
                                                                                                                           Collection Request Title: 0990–0263-
                                               collection for public comment.                                                                                                                          (Common Rule) which is identical to 45
                                                                                                                           Extension Protection of Human Subjects
                                               DATES: Comments on the ICR must be                                                                                                                      CFR part 46, subpart A.
                                                                                                                           Assurance Identification/IRB
                                               received on or before February 9, 2018.                                     Certification/Declaration of Exemption                                        Likely Respondents: Individuals,
                                               ADDRESSES: Submit your comments to                                          (Common Rule) form.                                                         business or other for-profit, not for-
                                               Sherrette.Funn@hhs.gov or by calling                                          Abstract: Assistant Secretary for                                         profit institutions, Federal, State, Local
                                               (202) 795–7714.                                                             Health, Office for Human Research                                           or Tribal Governments.

                                                                                                                 ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE
                                                                                                                                                                                                                                   Average
                                                                                                                                                                                                     Number of
                                                                                                                                                                          Number of                                              burden per              Total burden
                                                                                                Form name                                                                                          responses per
                                                                                                                                                                         respondents                                              response                  hours
                                                                                                                                                                                                     respondent                   (in hours)

                                               Protection of Human Subjects: Assurance Identification/IRB Certification/
                                                 Declaration of Exemption .............................................................................                              14,000                              2                       0.5           14,000

                                                     Total ..........................................................................................................   ........................   ........................   ........................         14,000



                                               Terry S. Clark,                                                             identification of specific candidates for                                   DEPARTMENT OF HEALTH AND
                                               Asst Information Collection Clearance                                       leadership positions at the NIH in                                          HUMAN SERVICES
                                               Officer.                                                                    accordance with the provisions set forth
                                               [FR Doc. 2017–26568 Filed 12–8–17; 8:45 am]                                 in sections 552b(c)(9)(B) and 552b(c)(6),                                   National Institutes of Health
                                               BILLING CODE 4150&ndash36–P                                                 Title 5 U.S.C., as amended. Premature
                                                                                                                           disclosure of potential candidates and                                      National Institute on Aging; Notice of
                                                                                                                           their qualifications, as well as the                                        Meeting
                                               DEPARTMENT OF HEALTH AND                                                    discussions by the committee, could                                            Pursuant to section 10(d) of the
                                               HUMAN SERVICES                                                              significantly frustrate NIH’s ability to                                    Federal Advisory Committee Act, as
                                                                                                                           recruit these individuals and the                                           amended, notice is hereby given of a
                                               National Institutes of Health                                               consideration of personnel                                                  meeting of the National Advisory
                                               Office of the Director; Amended Notice                                      qualifications, performance, and the                                        Council on Aging.
                                               of Meeting                                                                  competence of individuals as candidates                                        The meeting will be open to the
                                                                                                                           would constitute a clearly unwarranted                                      public as indicated below, with
                                                 Notice is hereby given of a change in                                     invasion of personal privacy.                                               attendance limited to space available.
                                               the meeting of the Advisory Committee                                         There are no changes for the open                                         Individuals who plan to attend and
                                               to the Director, National Institutes of                                     portion of the meeting scheduled for                                        need special assistance, such as sign
                                               Health, December 14, 9:00 a.m. to 5:30                                      December 15, 2017.                                                          language interpretation or other
daltland on DSKBBV9HB2PROD with NOTICES




                                               p.m. and December 15, 2017, 9:00 a.m.                                                                                                                   reasonable accommodations, should
                                               to 1:00 p.m., that was published in the                                       Dated: December 5, 2017.
                                                                                                                                                                                                       notify the Contact Person listed below
                                               Federal Register on Tuesday, November                                       Anna Snouffer,                                                              in advance of the meeting.
                                               14, 2017, 82 FR 52737.                                                      Deputy Director, Office of Federal Advisory                                    The meeting will be closed to the
                                                 The meeting will be closed to the                                         Committee Policy.                                                           public in accordance with the
                                               public on December 14, 2017, from 4:45                                      [FR Doc. 2017–26548 Filed 12–8–17; 8:45 am]                                 provisions set forth in sections
                                               p.m. to 5:15 p.m. for the discussion and                                    BILLING CODE 4140–01–P                                                      552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,


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Document Created: 2017-12-09 01:49:15
Document Modified: 2017-12-09 01:49:15
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by January 10, 2018.
ContactAmber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]
FR Citation82 FR 58211 

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