81_FR_76580 81 FR 76368 - Proposed Collection; 60-Day Comment Request; Public Health Service Applications and Pre-Award Reporting Requirements (Office of the Director)

81 FR 76368 - Proposed Collection; 60-Day Comment Request; Public Health Service Applications and Pre-Award Reporting Requirements (Office of the Director)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 81, Issue 212 (November 2, 2016)

Page Range76368-76370
FR Document2016-26448

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Federal Register, Volume 81 Issue 212 (Wednesday, November 2, 2016)
[Federal Register Volume 81, Number 212 (Wednesday, November 2, 2016)]
[Notices]
[Pages 76368-76370]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-26448]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; Public Health 
Service Applications and Pre-Award Reporting Requirements (Office of 
the Director)

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995 to provide opportunity for public comment on proposed data 
collection projects, the National Institutes of Health (NIH) will 
publish periodic summaries of proposed projects to be submitted to the 
Office of Management and Budget (OMB) for review and approval.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 60 days of the date of 
this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, submit comments in writing, or 
request more information on the proposed project, contact: Ms. Mikia P. 
Currie, Program

[[Page 76369]]

Analyst, Office of Policy for Extramural Research Administration, 6705 
Rockledge Drive, Suite 350, Bethesda, Maryland 20892, or call a non-
toll-free number 301-435-0941 or Email your request, including your 
address to [email protected]. Formal requests for additional plans 
and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 requires: Written comments and/or suggestions 
from the public and affected agencies are invited to address one or 
more of the following points: (1) Whether the proposed collection of 
information is necessary for the proper performance of the function of 
the agency, including whether the information will have practical 
utility; (2) The accuracy of the agency's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) Ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) Ways 
to minimizes the burden of the collection of information on those who 
are to respond, including the use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.
    Proposed Collection Title: Public Health Service (PHS) Applications 
and Pre-Award Reporting Requirements, Revision, OMB 0925-0001, 
Expiration Date 10/31/2018. Form numbers: PHS 398, PHS 416-1, PHS 416-
5, and PHS 6031. This collection represents a consolidation of PHS 
applications and pre-award reporting requirements into a revised data 
collection under the PRA. This collection includes the proposed use of 
a new PHS clinical trial application form.
    Need and Use of Information Collection: This collection includes 
PHS applications and pre-award reporting requirements: PHS 398 (paper) 
Public Health Service Grant Application forms and instructions; PHS 398 
(electronic) PHS Grant Application component forms and agency specific 
instructions used in combination with the SF424 (R&R); PHS Fellowship 
Supplemental Form and agency specific instructions used in combination 
with the SF424 (R&R) forms/instructions for Fellowships (electronic); 
PHS 416-1 Ruth L. Kirschstein National Research Service Award 
Individual Fellowship Application Instructions and Forms used only for 
a change of sponsoring institution application [paper]; Instructions 
for a Change of Sponsoring Institution for the National Research 
Service Award (NRSA) Fellowships (F30, F31, F32 and F33) and non-NRSA 
Fellowships; PHS 416-5 Ruth L. Kirschstein National Research Service 
Award Individual Fellowship Activation Notice; and PHS 6031 Payback 
Agreement. The PHS 398 (paper and electronic) are currently approved 
under 0925-0001. All forms expire 10/31/2018. Post-award reporting 
requirements are simultaneously consolidated under 0925-0002, and 
include the Research Performance Progress Report (RPPR). The PHS 398 
and SF424 applications are used by applicants to request federal 
assistance funds for traditional investigator-initiated research 
projects and to request access to databases and other PHS resources. 
The PHS 416-1 is used only for a change of sponsoring institution 
application. PHS Fellowship Supplemental Form and agency specific 
instructions is used in combination with the SF424 (R&R) forms/
instructions for Fellowships and is used by individuals to apply for 
direct research training support. Awards are made to individual 
applicants for specified training proposals in biomedical and 
behavioral research, selected as a result of a national competition. 
The PHS 416-5 is used by individuals to indicate the start of their 
National Research Service Award (NRSA) awards. The PHS 6031 Payback 
Agreement is used by individuals at the time of activation to certify 
agreement to fulfill the payback provisions. Clinical trials are 
complex and challenging research activities. Oversight systems and 
tools are critical for the NIH to ensure participant safety, data 
integrity, and accountability of the use of public funds. The NIH has 
been engaged in a multi-year effort to examine how clinical trials are 
supported and the level of oversight needed. The collection of more 
structured information about proposed clinical trials in the PHS 
applications and pre-award reporting requirements will facilitate the 
NIH's oversight of clinical trials as well as assist in understanding 
where needs in the NIH research portfolio may exist. In addition, some 
of the data collected here will ultimately be accessible to 
investigators to pre-populate certain sections of forms when 
registering their trials with ClinicalTrials.gov.
    Frequency of response: Applicants may submit applications for 
published receipt dates. For NRSA awards, fellowships are activated and 
trainees appointed.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 850,756.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total annual
          Information collection forms              respondents    responses per   response  (in   burden hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
PHS 398--Paper..................................           4,247               1              35         148,645
PHS 398/424--Electronic:
    PHS Assignment Request Form.................          37,120               1           30/60          18,560
    PHS 398 Cover Page Supplement...............          74,239               1               1          74,239
    PHS Inclusion Enrollment Report.............          54,838               1               1          54,838
    PHS 398 Modular Budget......................          56,693               1               1          56,693
    PHS 398 Training Budget.....................           1,122               1               2           2,244
    PHS 398 Training Subaward Budget                         561               1           90/60             842
     Attachment(s) Form.........................
    PHS 398 Research Plan.......................          70,866               1               3         212,598
    PHS 398 Research Training Program Plan......           1,122               1               3           3,366
    Data Tables.................................           1,515               1               4           6,060
    PHS 398 Career Development Award                       2,251               1               3           6,753
     Supplemental Form..........................
    PHS Clinical Trial Protocol Form............           8,264               1               1           8,264
    Biosketch (424 Electronic)..................          80,946               1               2         161,892
PHS Fellowship--Electronic:
    PHS Fellowship Supplemental Form (includes F           6,707               1            12.5          83,838
     reference letters).........................

[[Page 76370]]

 
    PHS Assignment Request Form.................           3,354               1           30/60           1,677
    PHS Inclusion Enrollment Report.............           3,354               1               1           3,354
    Biosketch (Fellowship)......................           6,707               1               2          13,414
    416-1.......................................              29               1              10             290
    PHS 416-5...................................           6,707               1            5/60             559
    PHS 6031....................................           6,217               1            5/60             518
    VCOC Certification..........................               6               1            5/60               1
    SBIR/STTR Funding Agreement Certification...           1,500               1           15/60             375
                                                 ---------------------------------------------------------------
        Total Annual Burden Hours...............  ..............         420,101  ..............         850,756
----------------------------------------------------------------------------------------------------------------


    Dated: October 22, 2016.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2016-26448 Filed 11-1-16; 8:45 am]
 BILLING CODE 4140-01-P



                                                76368                    Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices

                                                  The meetings will be closed to the                       Name of Committee: Center for Scientific             Contact Person: Cristina Backman, Ph.D.,
                                                public in accordance with the                           Review Special Emphasis Panel; Small                  Scientific Review Officer, ETTN IRG, Center
                                                provisions set forth in sections                        Business: Risk, Prevention and Health                 for Scientific Review, National Institutes of
                                                                                                        Behavior.                                             Health, 6701 Rockledge Drive, Room 5211,
                                                552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                                                                           Date: December 1–2, 2016.                          MSC 7846, Bethesda, MD 20892, cbackman@
                                                as amended. The grant applications and                     Time: 8:00 a.m. to 5:00 p.m.                       mail.nih.gov.
                                                the discussions could disclose                             Agenda: To review and evaluate grant                 Name of Committee: Center for Scientific
                                                confidential trade secrets or commercial                applications.                                         Review Special Emphasis Panel; Member
                                                property such as patentable material,                      Place: Embassy Suites at the Chevy Chase           Conflict: Topics in Mechanisms of Bacterial
                                                and personal information concerning                     Pavilion, 4300 Military Road NW.,                     Virulence and Pathogenesis.
                                                individuals associated with the grant                   Washington, DC 20015.                                   Date: December 2, 2016.
                                                applications, the disclosure of which                      Contact Person: Claire E. Gutkin, MPH,               Time: 10:00 a.m. to 5:30 p.m.
                                                would constitute a clearly unwarranted                  Ph.D., Scientific Review Officer, Center for            Agenda: To review and evaluate grant
                                                invasion of personal privacy.                           Scientific Review, National Institutes of             applications.
                                                                                                        Health, 6701 Rockledge Drive, Room 3106,                Place: National Institutes of Health, 6701
                                                  Name of Committee: Center for Scientific              MSC 7808, Bethesda, MD 20892, 301–594–                Rockledge Drive, Bethesda, MD 20892.
                                                Review Special Emphasis Panel; PAR–16–                  3139, gutkincl@csr.nih.gov.                             Contact Person: Gagan Pandya, Ph.D.,
                                                121 Early-Stage Preclinical Validation of                  Name of Committee: Center for Scientific           Scientific Review Officer, National Institutes
                                                Therapeutic Leads for Diseases of Interest to           Review Special Emphasis Panel; Member                 of Health, Center for Scientific Review, 6701
                                                the NIDDK (R01).                                        Conflict: Digestive Diseases.                         Rockledge Drive, RM 3200, MSC 7808,
                                                  Date: November 17–18, 2016.                              Date: December 1–2, 2016.                          Bethesda, MD 20892, 301–435–1167,
                                                  Time: 11:00 a.m. to 5:00 p.m.                            Time: 8:00 a.m. to 7:00 p.m.                       pandyaga@mail.nih.gov.
                                                  Agenda: To review and evaluate grant                     Agenda: To review and evaluate grant               (Catalogue of Federal Domestic Assistance
                                                applications.                                           applications.                                         Program Nos. 93.306, Comparative Medicine;
                                                  Place: National Institutes of Health, 6701               Place: National Institutes of Health, 6701         93.333, Clinical Research, 93.306, 93.333,
                                                Rockledge Drive, Bethesda, MD 20892                     Rockledge Drive, Bethesda, MD 20892                   93.337, 93.393–93.396, 93.837–93.844,
                                                (Virtual Meeting).                                      (Virtual Meeting).                                    93.846–93.878, 93.892, 93.893, National
                                                  Contact Person: Antonello Pileggi, MD,                   Contact Person: Jianxin Hu, Ph.D.,                 Institutes of Health, HHS)
                                                Ph.D., Scientific Review Officer, Center for            Scientific Review Officer, Center for
                                                Scientific Review, National Institutes of                                                                       Dated: October 27, 2016.
                                                                                                        Scientific Review, National Institutes of
                                                Health, 6701 Rockledge Drive, Room 6166,                Health, 6701 Rockledge Drive, Room 2156,              David Clary,
                                                Bethesda, MD 20892–7892, (301) 402–6297,                Bethesda, MD 20892, 301–827–4417,                     Program Analyst, Office of Federal Advisory
                                                pileggia@csr.nih.gov.                                   jianxinh@csr.nih.gov.                                 Committee Policy.
                                                  This notice is being published less than 15              Name of Committee: Center for Scientific           [FR Doc. 2016–26451 Filed 11–1–16; 8:45 am]
                                                days prior to the meeting due to the timing             Review Special Emphasis Panel; Member                 BILLING CODE 4140–01–P
                                                limitations imposed by the review and                   Conflict: Kidney and Urology.
                                                funding cycle.                                             Date: December 1, 2016.
                                                  Name of Committee: Center for Scientific                 Time: 1:00 p.m. to 5:00 p.m.                       DEPARTMENT OF HEALTH AND
                                                Review Special Emphasis Panel; PAR–16–                     Agenda: To review and evaluate grant
                                                121 Early-Stage Preclinical Validation of
                                                                                                                                                              HUMAN SERVICES
                                                                                                        applications.
                                                Therapeutic Leads for Diseases of Interest to              Place: National Institutes of Health, 6701
                                                the NIDDK (R01).
                                                                                                                                                              National Institutes of Health
                                                                                                        Rockledge Drive, Bethesda, MD 20892
                                                  Date: November 17, 2016.                              (Telephone Conference Call).
                                                  Time: 11:30 a.m. to 12:00 p.m.
                                                                                                                                                              Proposed Collection; 60-Day Comment
                                                                                                           Contact Person: Aiping Zhao, MD,                   Request; Public Health Service
                                                  Agenda: To review and evaluate grant                  Scientific Review Officer, Center for
                                                applications.                                           Scientific Review, National Institutes of
                                                                                                                                                              Applications and Pre-Award Reporting
                                                  Place: National Institutes of Health, 6701            Health, 6701 Rockledge Drive, Rm 2188, MSC            Requirements (Office of the Director)
                                                Rockledge Drive, Bethesda, MD 20892                     7818, Bethesda, MD 20892–7818, (301) 435–
                                                (Virtual Meeting).
                                                                                                                                                              AGENCY:   National Institutes of Health,
                                                                                                        0682, zhaoa2@csr.nih.gov.                             HHS.
                                                  Contact Person: Hui Chen, MD, Scientific                 Name of Committee: Center for Scientific
                                                Review Officer, Center for Scientific Review,                                                                 ACTION:   Notice.
                                                                                                        Review Special Emphasis Panel; AREA:
                                                National Institutes of Health, 6701 Rockledge           Immunology.
                                                Drive, Bethesda, MD 20892, 301–435–1044,                                                                      SUMMARY:   In compliance with the
                                                                                                           Date: December 1, 2016.                            requirement of the Paperwork
                                                chenhui@csr.nih.gov.                                       Time: 12:30 p.m. to 4:00 p.m.
                                                  This notice is being published less than 15              Agenda: To review and evaluate grant
                                                                                                                                                              Reduction Act of 1995 to provide
                                                days prior to the meeting due to the timing             applications.                                         opportunity for public comment on
                                                limitations imposed by the review and                      Place: National Institutes of Health, 6701         proposed data collection projects, the
                                                funding cycle.                                          Rockledge Drive, Bethesda, MD 20892                   National Institutes of Health (NIH) will
                                                  Name of Committee: Center for Scientific              (Telephone Conference Call).                          publish periodic summaries of proposed
                                                Review Special Emphasis Panel; Vasular and                 Contact Person: Alok Mulky, Ph.D.,                 projects to be submitted to the Office of
                                                Hematology: Molecular and Cellular                      Scientific Review Officer, Center for                 Management and Budget (OMB) for
                                                Hematology.                                             Scientific Review (CSR), National Institutes          review and approval.
                                                  Date: November 30, 2016.                              of Health (NIH), 6701 Rockledge Dr., Room
                                                                                                                                                              DATES: Comments regarding this
                                                  Time: 4:00 p.m. to 5:00 p.m.                          4203, Bethesda, MD 20817, (301) 435–3566,
                                                  Agenda: To review and evaluate grant                  alok.mulky@nih.gov.                                   information collection are best assured
                                                applications.                                              Name of Committee: Center for Scientific           of having their full effect if received
                                                  Place: National Institutes of Health, 6701            Review Special Emphasis Panel; PAR16–027:             within 60 days of the date of this
sradovich on DSK3GMQ082PROD with NOTICES




                                                Rockledge Drive, Bethesda, MD 20892                     Commercialization Readiness Pilot.                    publication.
                                                (Telephone Conference Call).                               Date: December 2, 2016.
                                                                                                                                                              FOR FURTHER INFORMATION CONTACT: To
                                                  Contact Person: Luis Espinoza, Ph.D.,                    Time: 8:00 a.m. to 6:00 p.m.
                                                Scientific Review Officer, Center for                      Agenda: To review and evaluate grant               obtain a copy of the data collection
                                                Scientific Review, National Institutes of               applications.                                         plans and instruments, submit
                                                Health, 6701 Rockledge Drive, Room 4140,                   Place: Washington Marriott at Metro                comments in writing, or request more
                                                MSC 7814, Bethesda, MD 20892, 301–435–                  Center, 775 12th Street NW., Washington, DC           information on the proposed project,
                                                0952, espinozala@mail.nih.gov.                          20005.                                                contact: Ms. Mikia P. Currie, Program


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                                                                                Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices                                                              76369

                                                Analyst, Office of Policy for Extramural                              use of a new PHS clinical trial                              the SF424 (R&R) forms/instructions for
                                                Research Administration, 6705                                         application form.                                            Fellowships and is used by individuals
                                                Rockledge Drive, Suite 350, Bethesda,                                   Need and Use of Information                                to apply for direct research training
                                                Maryland 20892, or call a non-toll-free                               Collection: This collection includes PHS                     support. Awards are made to individual
                                                number 301–435–0941 or Email your                                     applications and pre-award reporting                         applicants for specified training
                                                request, including your address to                                    requirements: PHS 398 (paper) Public                         proposals in biomedical and behavioral
                                                trialsinfo@od.nih.gov. Formal requests                                Health Service Grant Application forms                       research, selected as a result of a
                                                for additional plans and instruments                                  and instructions; PHS 398 (electronic)                       national competition. The PHS 416–5 is
                                                must be requested in writing.                                         PHS Grant Application component                              used by individuals to indicate the start
                                                                                                                      forms and agency specific instructions                       of their National Research Service
                                                SUPPLEMENTARY INFORMATION:      Section
                                                                                                                      used in combination with the SF424                           Award (NRSA) awards. The PHS 6031
                                                3506(c)(2)(A) of the Paperwork
                                                                                                                      (R&R); PHS Fellowship Supplemental                           Payback Agreement is used by
                                                Reduction Act of 1995 requires: Written
                                                                                                                      Form and agency specific instructions                        individuals at the time of activation to
                                                comments and/or suggestions from the                                  used in combination with the SF424
                                                public and affected agencies are invited                                                                                           certify agreement to fulfill the payback
                                                                                                                      (R&R) forms/instructions for                                 provisions. Clinical trials are complex
                                                to address one or more of the following                               Fellowships (electronic); PHS 416–1
                                                points: (1) Whether the proposed                                                                                                   and challenging research activities.
                                                                                                                      Ruth L. Kirschstein National Research                        Oversight systems and tools are critical
                                                collection of information is necessary                                Service Award Individual Fellowship
                                                for the proper performance of the                                                                                                  for the NIH to ensure participant safety,
                                                                                                                      Application Instructions and Forms                           data integrity, and accountability of the
                                                function of the agency, including                                     used only for a change of sponsoring
                                                whether the information will have                                                                                                  use of public funds. The NIH has been
                                                                                                                      institution application [paper];                             engaged in a multi-year effort to
                                                practical utility; (2) The accuracy of the                            Instructions for a Change of Sponsoring
                                                agency’s estimate of the burden of the                                                                                             examine how clinical trials are
                                                                                                                      Institution for the National Research                        supported and the level of oversight
                                                proposed collection of information,                                   Service Award (NRSA) Fellowships
                                                including the validity of the                                                                                                      needed. The collection of more
                                                                                                                      (F30, F31, F32 and F33) and non-NRSA                         structured information about proposed
                                                methodology and assumptions used; (3)                                 Fellowships; PHS 416–5 Ruth L.
                                                Ways to enhance the quality, utility, and                                                                                          clinical trials in the PHS applications
                                                                                                                      Kirschstein National Research Service                        and pre-award reporting requirements
                                                clarity of the information to be                                      Award Individual Fellowship
                                                collected; and (4) Ways to minimizes                                                                                               will facilitate the NIH’s oversight of
                                                                                                                      Activation Notice; and PHS 6031                              clinical trials as well as assist in
                                                the burden of the collection of                                       Payback Agreement. The PHS 398
                                                information on those who are to                                                                                                    understanding where needs in the NIH
                                                                                                                      (paper and electronic) are currently                         research portfolio may exist. In
                                                respond, including the use of                                         approved under 0925–0001. All forms
                                                appropriate automated, electronic,                                                                                                 addition, some of the data collected here
                                                                                                                      expire 10/31/2018. Post-award reporting                      will ultimately be accessible to
                                                mechanical, or other technological                                    requirements are simultaneously
                                                collection techniques or other forms of                                                                                            investigators to pre-populate certain
                                                                                                                      consolidated under 0925–0002, and                            sections of forms when registering their
                                                information technology.                                               include the Research Performance                             trials with ClinicalTrials.gov.
                                                  Proposed Collection Title: Public                                   Progress Report (RPPR). The PHS 398
                                                Health Service (PHS) Applications and                                 and SF424 applications are used by                              Frequency of response: Applicants
                                                Pre-Award Reporting Requirements,                                     applicants to request federal assistance                     may submit applications for published
                                                Revision, OMB 0925–0001, Expiration                                   funds for traditional investigator-                          receipt dates. For NRSA awards,
                                                Date 10/31/2018. Form numbers: PHS                                    initiated research projects and to request                   fellowships are activated and trainees
                                                398, PHS 416–1, PHS 416–5, and PHS                                    access to databases and other PHS                            appointed.
                                                6031. This collection represents a                                    resources. The PHS 416–1 is used only                           OMB approval is requested for 3
                                                consolidation of PHS applications and                                 for a change of sponsoring institution                       years. There are no costs to respondents
                                                pre-award reporting requirements into a                               application. PHS Fellowship                                  other than their time. The total
                                                revised data collection under the PRA.                                Supplemental Form and agency specific                        estimated annualized burden hours are
                                                This collection includes the proposed                                 instructions is used in combination with                     850,756.

                                                                                                                     ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                       Average
                                                                                                                                                                                   Number of
                                                                                                                                                                 Number of                           burden per     Total annual
                                                                                  Information collection forms                                                                   responses per
                                                                                                                                                                respondents                           response      burden hours
                                                                                                                                                                                   respondent         (in hours)

                                                PHS 398—Paper .............................................................................................              4,247                1                35        148,645
                                                PHS 398/424—Electronic:
                                                   PHS Assignment Request Form ..............................................................                          37,120                 1             30/60         18,560
                                                   PHS 398 Cover Page Supplement ...........................................................                           74,239                 1                 1         74,239
                                                   PHS Inclusion Enrollment Report .............................................................                       54,838                 1                 1         54,838
                                                   PHS 398 Modular Budget ........................................................................                     56,693                 1                 1         56,693
                                                   PHS 398 Training Budget ........................................................................                     1,122                 1                 2          2,244
                                                   PHS 398 Training Subaward Budget Attachment(s) Form ......................                                             561                 1             90/60            842
sradovich on DSK3GMQ082PROD with NOTICES




                                                   PHS 398 Research Plan ..........................................................................                    70,866                 1                 3        212,598
                                                   PHS 398 Research Training Program Plan .............................................                                 1,122                 1                 3          3,366
                                                   Data Tables ..............................................................................................           1,515                 1                 4          6,060
                                                   PHS 398 Career Development Award Supplemental Form .....................                                             2,251                 1                 3          6,753
                                                   PHS Clinical Trial Protocol Form ..............................................................                      8,264                 1                 1          8,264
                                                   Biosketch (424 Electronic) ........................................................................                 80,946                 1                 2        161,892
                                                PHS Fellowship—Electronic:
                                                   PHS Fellowship Supplemental Form (includes F reference letters) ........                                              6,707                1              12.5         83,838



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                                                76370                            Federal Register / Vol. 81, No. 212 / Wednesday, November 2, 2016 / Notices

                                                                                                            ESTIMATED ANNUALIZED BURDEN HOURS—Continued
                                                                                                                                                                                                                      Average
                                                                                                                                                                                                   Number of
                                                                                                                                                                        Number of                                   burden per              Total annual
                                                                                   Information collection forms                                                                                  responses per
                                                                                                                                                                       respondents                                   response               burden hours
                                                                                                                                                                                                   respondent        (in hours)

                                                     PHS Assignment Request Form ..............................................................                                      3,354                   1                 30/60               1,677
                                                     PHS Inclusion Enrollment Report .............................................................                                   3,354                   1                     1               3,354
                                                     Biosketch (Fellowship) ..............................................................................                           6,707                   1                     2              13,414
                                                     416–1 ........................................................................................................                     29                   1                    10                 290
                                                     PHS 416–5 ...............................................................................................                       6,707                   1                  5/60                 559
                                                     PHS 6031 .................................................................................................                      6,217                   1                  5/60                 518
                                                     VCOC Certification ...................................................................................                              6                   1                  5/60                   1
                                                     SBIR/STTR Funding Agreement Certification ..........................................                                            1,500                   1                 15/60                 375

                                                           Total Annual Burden Hours ...............................................................                  ........................        420,101    ........................        850,756



                                                  Dated: October 22, 2016.                                               93.865, Research for Mothers and Children;                                and associated response time, should be
                                                Lawrence A. Tabak,                                                       93.929, Center for Medical Rehabilitation                                 directed to the: Office of Management
                                                                                                                         Research; 93.209, Contraception and                                       and Budget, Office of Regulatory Affairs,
                                                Deputy Director, National Institutes of Health.
                                                                                                                         Infertility Loan Repayment Program, National
                                                [FR Doc. 2016–26448 Filed 11–1–16; 8:45 am]                              Institutes of Health, HHS)
                                                                                                                                                                                                   OIRA_submission@omb.eop.gov or by
                                                BILLING CODE 4140–01–P                                                                                                                             fax to 202–395–6974, Attention: Desk
                                                                                                                           Dated: October 27, 2016.                                                Officer for NIH.
                                                                                                                         Michelle Trout,
                                                                                                                                                                                                   FOR FURTHER INFORMATION CONTACT: To
                                                DEPARTMENT OF HEALTH AND                                                 Program Analyst, Office of Federal Advisory                               request more information on the
                                                HUMAN SERVICES                                                           Committee Policy.
                                                                                                                                                                                                   proposed project or to obtain a copy of
                                                                                                                         [FR Doc. 2016–26386 Filed 11–1–16; 8:45 am]
                                                                                                                                                                                                   the data collection plans and
                                                National Institutes of Health                                            BILLING CODE 4140–01–P                                                    instruments, contact: Dr. Ann Hardy,
                                                Eunice Kennedy Shriver National                                                                                                                    NIH Extramural Human Research
                                                Institute of Child Health & Human                                                                                                                  Protections Officer and NIH
                                                                                                                         DEPARTMENT OF HEALTH AND
                                                Development; Notice of Closed                                                                                                                      Coordinator, Certificates of
                                                                                                                         HUMAN SERVICES
                                                Meeting                                                                                                                                            Confidentiality, 3701 Rockledge Dr. Rm.
                                                                                                                         National Institutes of Health                                             3002, Bethesda, MD 20892, or call non-
                                                  Pursuant to section 10(d) of the                                                                                                                 toll-free number (301) 435–2690 or
                                                Federal Advisory Committee Act, as                                       Submission for OMB Review; 30-Day                                         Email your request, including your
                                                amended (5 U.S.C. App.), notice is                                       Comment Request, National Institutes                                      address to: hardyan@od.nih.gov. Formal
                                                hereby given of the following meeting.                                   of Health Electronic Application                                          requests for additional plans and
                                                  The meeting will be closed to the                                      System for Certificates of                                                instruments must be requested in
                                                public in accordance with the                                            Confidentiality                                                           writing.
                                                provisions set forth in sections
                                                552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                               AGENCY:         National Institutes of Health,                            SUPPLEMENTARY INFORMATION:     Office of
                                                as amended. The grant applications and                                   HHS.                                                                      Extramural Research (OER), NIH, may
                                                the discussions could disclose                                           ACTION:       Notice.                                                     not conduct or sponsor, and the
                                                confidential trade secrets or commercial                                                                                                           respondent is not required to respond
                                                                                                                         SUMMARY:   In compliance with the                                         to, an information collection that has
                                                property such as patentable material,                                    Paperwork Reduction Act of 1995, the
                                                and personal information concerning                                                                                                                been extended, revised, or implemented
                                                                                                                         National Institutes of Health (NIH) has                                   on or after October 1, 1995, unless it
                                                individuals associated with the grant                                    submitted to the Office of Management
                                                applications, the disclosure of which                                                                                                              displays a currently valid OMB control
                                                                                                                         and Budget (OMB) a request for review                                     number.
                                                would constitute a clearly unwarranted                                   and approval of the information
                                                invasion of personal privacy.                                                                                                                        In compliance with Section
                                                                                                                         collection listed below. This proposed                                    3507(a)(1)(D) of the Paperwork
                                                  Name of Committee: National Institute of                               information collection was previously                                     Reduction Act of 1995, the NIH has
                                                Child Health and Human Development                                       published in the Federal Register on                                      submitted to the OMB a request for
                                                Special Emphasis Panel.                                                  August 18, 2016 (81 FR 55207–55208)
                                                  Date: December 8, 2016.                                                                                                                          review and approval of the information
                                                                                                                         and allowed 60-days for public                                            collection listed below.
                                                  Time: 9:00 a.m. to 3:00 p.m.
                                                  Agenda: To review and evaluate grant
                                                                                                                         comment. No public comments were                                            Proposed Collection: Certificate of
                                                applications.                                                            received. The purpose of this notice is                                   Confidentiality Electronic Application
                                                  Place: National Institutes of Health, 6705                             to allow an additional 30 days for public                                 System, 0925–0689, expiration date 01/
                                                Rockledge Drive, Bethesda, MD 20817,                                     comment.                                                                  31/2017, OER, NIH.
                                                (Virtual Meeting).                                                       DATES: Comments regarding this                                              Need and Use of Information
                                                  Contact Person: Priscah Mujuru, DRPH,                                  information collection are best assured                                   Collection: This application system
sradovich on DSK3GMQ082PROD with NOTICES




                                                COHNS, Scientific Review Officer, Scientific                             of having their full effect if received
                                                Review Branch, Eunice Kennedy Shriver
                                                                                                                                                                                                   provides one electronic form to be used
                                                                                                                         within 30-days of the date of this                                        by all research organizations that wish
                                                National Institute of Child Health and
                                                                                                                         publication.                                                              to request a Certificate of Confidentiality
                                                Human Development, NIH, 6100 Executive
                                                Boulevard, Suite 5B01, Bethesda, MD 20892–                               ADDRESSES: Written comments and/or                                        (CoC) from the NIH. As described in the
                                                7510, 301–435–6908, mujurup@mail.nih.gov.                                suggestions regarding the item(s)                                         authorizing legislation (Section 301(d)
                                                (Catalogue of Federal Domestic Assistance                                contained in this notice, especially                                      of the Public Health Service Act, 42
                                                Program Nos. 93.864, Population Research;                                regarding the estimated public burden                                     U.S.C. 241(d)), CoCs are issued by the


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Document Created: 2016-11-02 01:41:17
Document Modified: 2016-11-02 01:41:17
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.
DatesComments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
ContactTo obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Ms. Mikia P. Currie, Program Analyst, Office of Policy for Extramural Research Administration, 6705 Rockledge Drive, Suite 350, Bethesda, Maryland 20892, or call a non- toll-free number 301-435-0941 or Email your request, including your
FR Citation81 FR 76368 

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