83 FR 53883 - Agency Information Collection Activities; Proposed Collection; Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 207 (October 25, 2018)

Page Range		53883-53884
FR Document		2018-23282

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

Federal Register, Volume 83 Issue 207 (Thursday, October 25, 2018)

[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)]
[Notices]
[Pages 53883-53884]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-23282]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-0279]


Agency Information Collection Activities; Proposed Collection; 
Public Comment Request

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with the requirement of the Paperwork Reduction 
Act of 1995, the Office of the Secretary (OS), Department of Health and 
Human Services, is publishing the following summary of a proposed 
collection for public comment.

DATES: Comments on the ICR must be received on or before November 26, 
2018.

ADDRESSES: Submit your comments to [email protected] or by calling 
(202) 795-7714.

FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting 
information, please include the document identifier 0990-0279 New-30D 
and project title for reference, to [email protected], or call the 
Reports Clearance Officer at 202-795-7714.

SUPPLEMENTARY INFORMATION: Interested persons are invited to send 
comments regarding this burden estimate or any other aspect of this 
collection of information, including any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.
    Information Collection Request Title: 0990-0279--Extension--
Institutional Review Board Registration Form.
    Abstract: Assistant Secretary for Health, Office for Human Research 
Protections is requesting an extension on a currently approved 
information collection by the Office of Management and Budget, on the 
Protection of Human Subjects, on the Institutional Review Board (IRB) 
Form. The purpose of the IRB Registration Form is to provide a 
simplified procedure for institutions engaged in research conducted or 
supported by HHS to satisfy the (1) HHS regulations for the protection 
of human subjects at 45 CFR 46.103((b), 45 CFR 46.107, and 45 CFR 46, 
subpart E, Registration of Institutional Review Boards; and, the Food 
and Drug Administration (FDA) regulations for institutional review 
boards at 21 CFR 56.106.
    Likely Respondents: Institutions or organizations operating IRBs 
that review human subjects research conducted or supported by HHS, or, 
in the case of FDA's requirements, each IRB in the United States that 
reviews clinical investigations regulated by FDA under sections 505(i) 
or 520(g) of the Federal Food, Drug and Cosmetic Act; and each IRB in 
the United States that reviews clinical investigations that are 
intended to support applications for research or marketing permits for 
FDA-regulated products.

                                    Estimate Annualized Burden in Hours Table
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                    Form name                        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
IRB Registration Update.........................           5,650               2           30/60           5,650

[[Page 53884]]

 
IRB Registration Initial and Update.............             350               2           45/60             525
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............           6,175
----------------------------------------------------------------------------------------------------------------


Terry Clark,
Asst Paperwork Reduction Act Reports Clearance Officer, Office of the 
Secretary.
[FR Doc. 2018-23282 Filed 10-24-18; 8:45 am]
BILLING CODE 4150-36-P

Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices 53883

pharmaceuticals on the male II. Paperwork Reduction Act of 1995 New-30D and project title for reference,
reproductive system. The guidance This guidance refers to previously to Sherrette.funn@hhs.gov, or call the
discusses findings in nonclinical studies approved collections of information that Reports Clearance Officer at 202–795–
that may increase the level of concern are subject to review by the Office of 7714.
for drug-related testicular toxicity. The Management and Budget (OMB) under
guidance provides a general approach SUPPLEMENTARY INFORMATION: Interested
the Paperwork Reduction Act of 1995 persons are invited to send comments
on how to weigh the relevance of (44 U.S.C. 3501–3520). The collections
nonclinical findings, considering factors regarding this burden estimate or any
of information in 21 CFR part 312 have
that can confound the interpretation of other aspect of this collection of
been approved under OMB control
these findings. If a concerning information, including any of the
number 0910–0014. The collections of
nonclinical signal is identified, the following subjects: (1) The necessity and
information in 21 CFR parts 50 and 56
guidance presents suggestions for utility of the proposed information
(‘‘Protection of Human Subjects:
clinical monitoring when the product is collection for the proper performance of
Informed Consent and Institutional
initially administered to humans. the agency’s functions; (2) the accuracy
Review Boards’’) have been approved
If a reasonable basis for concern of of the estimated burden; (3) ways to
under OMB control number 0910–0755.
human testicular toxicity exists, a trial enhance the quality, utility, and clarity
with a primary objective of evaluating III. Electronic Access of the information to be collected; and
drug-related testicular toxicity may be Persons with access to the internet (4) the use of automated collection
warranted. The guidance provides may obtain the guidance at either techniques or other forms of information
recommendations for the design of such https://www.fda.gov/Drugs/Guidance technology to minimize the information
a trial, including study conduct, ComplianceRegulatoryInformation/ collection burden.
endpoints, and presentation of results. Guidances/default.htm or https:// Information Collection Request Title:
These are general recommendations for www.regulations.gov. 0990–0279—Extension—Institutional
defining the role of drugs in testicular Review Board Registration Form.
Dated: October 19, 2018.
injury; however, the specific details of
an individual trial may vary depending Leslie Kux, Abstract: Assistant Secretary for
on the context of use of the drug Associate Commissioner for Policy. Health, Office for Human Research
product. [FR Doc. 2018–23304 Filed 10–24–18; 8:45 am] Protections is requesting an extension
This guidance finalizes the draft BILLING CODE 4164–01–P
on a currently approved information
guidance of the same name issued on collection by the Office of Management
July 17, 2015 (80 FR 42501). Changes and Budget, on the Protection of Human
made to the guidance took into DEPARTMENT OF HEALTH AND Subjects, on the Institutional Review
consideration written and verbal HUMAN SERVICES Board (IRB) Form. The purpose of the
comments received. In addition to IRB Registration Form is to provide a
[Document Identifier: OS–0990–0279] simplified procedure for institutions
editorial changes primarily for
clarification, the major changes in the Agency Information Collection engaged in research conducted or
guidance include revision of Activities; Proposed Collection; Public supported by HHS to satisfy the (1) HHS
information on nonclinical study design Comment Request regulations for the protection of human
(including species selection, chronic subjects at 45 CFR 46.103((b), 45 CFR
study design, histopathology AGENCY: Office of the Secretary, HHS. 46.107, and 45 CFR 46, subpart E,
assessment, sperm quality, and findings ACTION: Notice. Registration of Institutional Review
that increase concern for impaired Boards; and, the Food and Drug
SUMMARY: In compliance with the Administration (FDA) regulations for
fertility) and revision of information requirement of the Paperwork
that, to the extent possible, subjects institutional review boards at 21 CFR
Reduction Act of 1995, the Office of the 56.106.
enrolled in the dedicated clinical safety Secretary (OS), Department of Health
trial represent the intended population. and Human Services, is publishing the Likely Respondents: Institutions or
This guidance is being issued following summary of a proposed organizations operating IRBs that review
consistent with FDA’s good guidance collection for public comment. human subjects research conducted or
practices regulation (21 CFR 10.115). supported by HHS, or, in the case of
DATES: Comments on the ICR must be
The guidance represents the current FDA’s requirements, each IRB in the
received on or before November 26,
thinking of FDA on the evaluation of United States that reviews clinical
2018.
testicular toxicity during drug investigations regulated by FDA under
development. It does not establish any ADDRESSES: Submit your comments to sections 505(i) or 520(g) of the Federal
rights for any person and is not binding Sherette.Funn@hhs.gov or by calling Food, Drug and Cosmetic Act; and each
on FDA or the public. You can use an (202) 795–7714. IRB in the United States that reviews
alternative approach if it satisfies the FOR FURTHER INFORMATION CONTACT: clinical investigations that are intended
requirements of the applicable statutes When submitting comments or to support applications for research or
and regulations. This guidance is not requesting information, please include marketing permits for FDA-regulated
subject to Executive Order 12866. the document identifier 0990–0279 products.

ESTIMATE ANNUALIZED BURDEN IN HOURS TABLE
daltland on DSKBBV9HB2PROD with NOTICES

Average
Number of
Number of burden per Total burden
Form name responses per
respondents response hours
respondent (in hours)

IRB Registration Update .................................................................................. 5,650 2 30/60 5,650

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53884 Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices

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

IRB Registration Initial and Update ................................................................. 350 2 45/60 525

Total .......................................................................................................... ........................ ........................ ........................ 6,175

Terry Clark, Scientific Review, National Institutes of Place: National Institutes of Health, 6701
Asst Paperwork Reduction Act Reports Health, 6701 Rockledge Drive, Room 6170, Rockledge Drive, Bethesda, MD 20892
Clearance Officer, Office of the Secretary. MSC 7892, Bethesda, MD 20892, 301–435– (Virtual Meeting).
1041, chengc@csr.nih.gov. Contact Person: Ai-Ping Zou, MD, Ph.D.,
[FR Doc. 2018–23282 Filed 10–24–18; 8:45 am]
Name of Committee: Center for Scientific Scientific Review Officer, Center for
BILLING CODE 4150–36–P Scientific Review, National Institutes of
Review Special Emphasis Panel; Small
Business: Endocrinology, Metabolism, Health, 6701 Rockledge Drive, Room 4118,
Nutrition and Reproductive Sciences. MSC 7814, Bethesda, MD 20892, 301–408–
DEPARTMENT OF HEALTH AND Date: November 15–16, 2018. 9497, zouai@csr.nih.gov.
HUMAN SERVICES Time: 8:00 a.m. to 5:00 p.m. Name of Committee: Center for Scientific
Agenda: To review and evaluate grant Review Special Emphasis Panel;
National Institutes of Health applications. Musculoskeletal, Oral, Skin, Rheumatology
Place: JW Marriott New Orleans, 614 Canal and Rehab Sciences AREA (R15) Review.
Center for Scientific Review; Notice of Street, New Orleans, LA 70130. Date: November 20, 2018.
Closed Meetings Contact Person: Clara M. Cheng, Ph.D., Time: 8:30 a.m. to 5:00 p.m.
Scientific Review Officer, Center for Agenda: To review and evaluate grant
Pursuant to section 10(d) of the Scientific Review, National Institutes of applications.
Federal Advisory Committee Act, as Health, 6701 Rockledge Drive, Room 6170, Place: Bahia Resort Hotel, 998 West
amended, notice is hereby given of the MSC 7892, Bethesda, MD 20892, 301–435– Mission Bay Drive, San Diego, CA 92109.
following meetings. 1041, chengc@csr.nih.gov. Contact Person: Aftab A Ansari, Ph.D.,
The meetings will be closed to the Scientific Review Officer, Center for
Name of Committee: Center for Scientific
Scientific Review, National Institutes of
public in accordance with the Review Special Emphasis Panel; PAR Panel:
Health, 6701 Rockledge Drive, Room 4108,
provisions set forth in sections Translational Research in Pediatric and
MSC 7814, Bethesda, MD 20892, 301–237–
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Obstetric Pharmacology and Therapeutics.
9931, ansaria@csr.nih.gov.
as amended. The grant applications and Date: November 16, 2018.
Time: 11:00 a.m. to 3:00 p.m. (Catalogue of Federal Domestic Assistance
the discussions could disclose Program Nos. 93.306, Comparative Medicine;
Agenda: To review and evaluate grant
confidential trade secrets or commercial applications. 93.333, Clinical Research; 93.306, 93.333,
property such as patentable material, Place: National Institutes of Health, 6701 93.337, 93.393–93.396, 93.837–93.844,
and personal information concerning Rockledge Drive, Bethesda, MD 20892 93.846–93.878, 93.892, 93.893, National
individuals associated with the grant (Virtual Meeting). Institutes of Health, HHS)
applications, the disclosure of which Contact Person: Dianne Hardy, Ph.D., Dated: October 19, 2018.
would constitute a clearly unwarranted Scientific Review Officer, Center for Natasha M. Copeland,
invasion of personal privacy. Scientific Review, National Institutes of
Program Analyst, Office of Federal Advisory
Health, 6701 Rockledge Drive, Room 6175,
Name of Committee: Center for Scientific Committee Policy.
MSC 7892, Bethesda, MD 20892, 301–435–
Review Special Emphasis Panel; 1154, dianne.hardy@nih.gov. [FR Doc. 2018–23267 Filed 10–24–18; 8:45 am]
Fellowships: Cell Biology, Developmental BILLING CODE 4140–01–P
Name of Committee: Center for Scientific
Biology, and Bioengineering.
Review Special Emphasis Panel; PAR Panel:
Date: November 13–14, 2018.
Discovery of Molecular Targets and
Time: 10:00 a.m. to 8:00 p.m.
Therapeutics for Pregnancy-Related Diseases; DEPARTMENT OF HEALTH AND
Agenda: To review and evaluate grant
applications. Drug Repurposing for Conditions Affecting HUMAN SERVICES
Place: National Institutes of Health, 6701 Neonates and Pregnant Women.
Rockledge Drive, Bethesda, MD 20892. Date: November 16, 2018. National Institutes of Health
Contact Person: Alexander Gubin, Ph.D., Time: 3:30 p.m. to 5:00 p.m.
Scientific Review Officer, Center for Agenda: To review and evaluate grant National Institute of Neurological
Scientific Review, National Institutes of applications. Disorders and Stroke; Notice of Closed
Health, 6701 Rockledge Drive, Room 4196, Place: National Institutes of Health, 6701 Meetings
MSC 7812, Bethesda, MD 20892, 301–435– Rockledge Drive, Bethesda, MD 20892
2902, gubina@csr.nih.gov. (Virtual Meeting). Pursuant to section 10(d) of the
Contact Person: Dianne Hardy, Ph.D., Federal Advisory Committee Act, as
Name of Committee: Center for Scientific
Scientific Review Officer, Center for amended, notice is hereby given of the
Review Special Emphasis Panel; RFA–HD–
Scientific Review, National Institutes of following meetings.
19–001 Safe and Effective Devices for Use in
Neonatal, Perinatal and Pediatric Care Health, 6701 Rockledge Drive, Room 6175, The meetings will be closed to the
MSC 7892, Bethesda, MD 20892, 301–435–
Settings. public in accordance with the
daltland on DSKBBV9HB2PROD with NOTICES

Date: November 15, 2018. 1154, dianne.hardy@nih.gov.
provisions set forth in sections
Time: 8:00 a.m. to 2:00 p.m. Name of Committee: Center for Scientific
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Agenda: To review and evaluate grant Review Special Emphasis Panel; Member
Conflict: Blood and Vascular Biology. as amended. The grant applications and
applications.
Place: JW Marriott New Orleans, 614 Canal Date: November 19–20, 2018. the discussions could disclose
Street, New Orleans, LA 70130. Time: 10:00 a.m. to 6:00 p.m. confidential trade secrets or commercial
Contact Person: Clara M. Cheng, Ph.D., Agenda: To review and evaluate grant property such as patentable material,
Scientific Review Officer, Center for applications. and personal information concerning

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Document Created: 2018-10-25 01:43:55
Document Modified: 2018-10-25 01:43:55

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments on the ICR must be received on or before November 26, 2018.
Contact		When submitting comments or requesting information, please include the document identifier 0990-0279 New-30D and project title for reference, to [email protected], or call the Reports Clearance Officer at 202-795-7714.
FR Citation		83 FR 53883