80 FR 41507 - Agency Information Collection Activities; Proposed Collection; Public Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 135 (July 15, 2015)

Page Range		41507-41508
FR Document		2015-17348

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary, Department of Health and Human Services (HHS), announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0279, which expires on August 31, 2015. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Federal Register, Volume 80 Issue 135 (Wednesday, July 15, 2015)

[Federal Register Volume 80, Number 135 (Wednesday, July 15, 2015)]
[Notices]
[Pages 41507-41508]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-17348]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: HHS-0990-0279-60D]


Agency Information Collection Activities; Proposed Collection; 
Public Comment Request

AGENCY: Office of the Assistant Secretary for Health, HHS.

ACTION: Notice.

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SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995, the Office of the Secretary, Department of 
Health and Human Services (HHS), announces plans to submit an 
Information Collection Request (ICR), described below, to the Office of 
Management and Budget (OMB). The ICR is for extending the use of the 
approved information collection assigned OMB control number 0990-0279, 
which expires on August 31, 2015. Prior to submitting that ICR to OMB, 
OS seeks comments from the public regarding the burden estimate, below, 
or any other aspect of the ICR.

DATES: Comments on the ICR must be received on or before September 14, 
2015.

ADDRESSES: Submit your comments to 
[email protected] or by calling (202) 690-6162.

FOR FURTHER INFORMATION CONTACT: Information Collection Clearance 
staff, [email protected] or (202) 690-6162.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the document identifier 0990-0279 for 
reference.
    Information Collection Request Title: Institutional Review Board 
Form--OMB No. 0990-0279, Assistant Secretary for Health, Office for 
Human Research Protections.
    Abstract: Section 491(a) of Public Law 99-158 states that the 
Secretary of HHS shall by regulation require that each entity applying 
for HHS support (e.g., a grant, contract, or cooperative agreement) to 
conduct research involving human subjects submit to HHS assurances 
satisfactory to the Secretary that it has established an institutional 
review board (IRB) to review the research in order to ensure protection 
of the rights and welfare of the human research subjects. IRBs are 
boards, committees, or groups formally designated by an entity to 
review, approve, and have continuing oversight of research involving 
human subjects.
    The Office for Human Research Protections (OHRP) and the Food and 
Drug Administration (FDA) are requesting a three-year extension of the 
OMB No. 0990-0279, Institutional Review Board (IRB) Registration Form. 
This form was modified in 2009 to be consistent with IRB registration 
requirements, 45 CFR part 46, subpart E and 21 CFR 56.106 that were 
adopted in July 2009 OHRP and FDA, respectively.
    Need and Proposed Use of the Information: The information collected 
through the Institutional Review Board registration collection 
requirements is the minimum necessary to satisfy the registration 
requirements of Section 491 (a) of the Public Health Service Act, 45 
CFR part 46, subpart E and 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 regulations, IRBs in the United States that review 
clinical investigations regulated by FDA under sections 505(i) or 
520(g) of the Federal Food, Drug and Cosmetic Act; and, IRBs in the 
United States that review clinical investigations that are intended to 
support applications for research or marketing permits for FDA-
regulated products.
    Burden Statement: The burden estimates for the IRB registration 
form include those approved by OMB in March 2015 under Control Number 
0990-0263, the Assurance Identification/IRB Certification/Declaration 
of Exemption form (former Optional Form 310). Those burden estimates 
are not included as part of the burden estimate presented below.

                                        Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
                    Form name                       respondents    responses per   response  (in       hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
IRB Registration 0990-0279......................           5,900               2               1          11,800
                                                             500               2               1           1,000
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............          12,800
----------------------------------------------------------------------------------------------------------------


[[Page 41508]]

    OS specifically requests comments on (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.

Terry S. Clark,
Asst Information Collection Clearance Officer.
[FR Doc. 2015-17348 Filed 7-14-15; 8:45 am]
 BILLING CODE 4150-28-P

Federal Register / Vol. 80, No. 135 / Wednesday, July 15, 2015 / Notices 41507

ICCR is a voluntary international ACTION: Notice. approve, and have continuing oversight
group of cosmetics regulatory of research involving human subjects.
authorities from the United States, SUMMARY: In compliance with section
3506(c)(2)(A) of the Paperwork The Office for Human Research
Japan, the European Union, Canada, and Protections (OHRP) and the Food and
Brazil. These regulatory authority Reduction Act of 1995, the Office of the
Secretary, Department of Health and Drug Administration (FDA) are
members will enter into constructive
Human Services (HHS), announces requesting a three-year extension of the
dialogue with their relevant cosmetics
industry trade associations and public plans to submit an Information OMB No. 0990–0279, Institutional
advocacy groups. Currently, the ICCR Collection Request (ICR), described Review Board (IRB) Registration Form.
members are: Health Canada; the below, to the Office of Management and This form was modified in 2009 to be
European Commission Directorate- Budget (OMB). The ICR is for extending consistent with IRB registration
General for Internal Market, Industry, the use of the approved information requirements, 45 CFR part 46, subpart E
Entrepreneurship, and Subject Matter collection assigned OMB control and 21 CFR 56.106 that were adopted in
Experts; the Ministry of Health, Labor, number 0990–0279, which expires on July 2009 OHRP and FDA, respectively.
and Welfare of Japan; the Brazilian August 31, 2015. Prior to submitting Need and Proposed Use of the
Health Surveillance Agency; and FDA. that ICR to OMB, OS seeks comments Information: The information collected
All decisions made by consensus will be from the public regarding the burden through the Institutional Review Board
compatible with the laws, policies, estimate, below, or any other aspect of
registration collection requirements is
rules, regulations, and directives of the the ICR.
the minimum necessary to satisfy the
respective administrations and DATES: Comments on the ICR must be registration requirements of Section 491
governments. Members will implement received on or before September 14, (a) of the Public Health Service Act, 45
and/or promote actions or documents 2015.
within their own jurisdictions and seek CFR part 46, subpart E and 21 CFR
ADDRESSES: Submit your comments to 56.106.
convergence of regulatory policies and
practices. Successful implementation Information.CollectionClearance@ Likely Respondents: Institutions or
will need input from stakeholders. hhs.gov or by calling (202) 690–6162. organizations operating IRBs that review
Agenda: We will make the agenda for FOR FURTHER INFORMATION CONTACT: human subjects research conducted or
the public meeting available on the Information Collection Clearance staff, supported by HHS, or, in the case of
Internet at http://www.fda.gov/ Information.CollectionClearance@ FDA’s regulations, IRBs in the United
Cosmetics/InternationalActivities/ICCR/ hhs.gov or (202) 690–6162. States that review clinical investigations
default.htm. Depending on the number SUPPLEMENTARY INFORMATION: When regulated by FDA under sections 505(i)
of requests for oral presentations, we submitting comments or requesting or 520(g) of the Federal Food, Drug and
intend to have an agenda available by information, please include the Cosmetic Act; and, IRBs in the United
September 3, 2015. We may use the document identifier 0990–0279 for States that review clinical investigations
information that you provide to us reference. that are intended to support
during the public meeting to help us Information Collection Request Title:
prepare for the November 4–6, 2015, applications for research or marketing
Institutional Review Board Form—OMB
ICCR–9 meeting. permits for FDA-regulated products.
No. 0990–0279, Assistant Secretary for
Dated: July 9, 2015. Health, Office for Human Research Burden Statement: The burden
Leslie Kux, Protections. estimates for the IRB registration form
Associate Commissioner for Policy. Abstract: Section 491(a) of Public Law include those approved by OMB in
99–158 states that the Secretary of HHS March 2015 under Control Number
[FR Doc. 2015–17248 Filed 7–14–15; 8:45 am]
shall by regulation require that each 0990–0263, the Assurance
BILLING CODE 4164–01–P
entity applying for HHS support (e.g., a Identification/IRB Certification/
grant, contract, or cooperative Declaration of Exemption form (former
DEPARTMENT OF HEALTH AND agreement) to conduct research Optional Form 310). Those burden
HUMAN SERVICES involving human subjects submit to estimates are not included as part of the
HHS assurances satisfactory to the burden estimate presented below.
[Document Identifier: HHS–0990–0279–60D] Secretary that it has established an
institutional review board (IRB) to
Agency Information Collection
review the research in order to ensure
Activities; Proposed Collection; Public
protection of the rights and welfare of
Comment Request
the human research subjects. IRBs are
AGENCY: Office of the Assistant boards, committees, or groups formally
Secretary for Health, HHS. designated by an entity to review,

ESTIMATED ANNUALIZED BURDEN TABLE
Average
Number of
Number of burden per Total burden
Form name responses per
respondents response hours
respondent (in hours)
mstockstill on DSK4VPTVN1PROD with NOTICES

IRB Registration 0990–0279 ........................................................................... 5,900 2 1 11,800
500 2 1 1,000

Total .......................................................................................................... ........................ ........................ ........................ 12,800

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41508 Federal Register / Vol. 80, No. 135 / Wednesday, July 15, 2015 / Notices

OS specifically requests comments on were received. The purpose of this Proposed Collection: Prostate, Lung,
(1) the necessity and utility of the notice is to allow an additional 30 days Colorectal and Ovarian Cancer
proposed information collection for the for public comment. The National Screening Trial (PLCO) 0925–0407,
proper performance of the agency’s Cancer Institute (NCI), National Revision, National Cancer Institute
functions, (2) the accuracy of the Institutes of Health, may not conduct or (NCI), National Institutes of Health
estimated burden, (3) ways to enhance sponsor, and the respondent is not (NIH).
the quality, utility, and clarity of the required to respond to, an information Need and Use of Information
information to be collected, and (4) the collection that has been extended, Collection: This is a request for a
use of automated collection techniques revised, or implemented on or after revision of the Prostate, Lung, Colorectal
or other forms of information October 1, 1995, unless it displays a and Ovarian Cancer Screening Trial
technology to minimize the information currently valid OMB control number. (PLCO). This trial was designed to
collection burden. Direct Comments to OMB: Written determine if cancer screening for
Terry S. Clark, comments and/or suggestions regarding prostate, lung, colorectal, and ovarian
Asst Information Collection Clearance
the item(s) contained in this notice, cancer can reduce mortality from these
Officer. especially regarding the estimated cancers which caused an estimated
[FR Doc. 2015–17348 Filed 7–14–15; 8:45 am]
public burden and associated response 253,320 deaths in the U.S in 2014. The
time, should be directed to the: Office design is a two-armed randomized trial
BILLING CODE 4150–28–P
of Management and Budget, Office of of men and women aged 55 to 74 at
Regulatory Affairs, entry. OMB first approved this study in
DEPARTMENT OF HEALTH AND OIRA_submission@omb.eop.gov or by 1993 and has approved it every 3 years
HUMAN SERVICES fax to 202–395–6974, Attention: NIH since then. Recruitment was completed
Desk Officer. in 2001, baseline cancer screening was
National Institutes of Health Comment Due Date: Comments completed in 2006, and data collection
regarding this information collection are continues on the current cohort of
Submission for OMB Review; 30-Day best assured of having their full effect if 77,281 participants who are actively
Comment Request Prostate, Lung, received within 30 days of the date of being followed. The additional follow-
Colorectal and Ovarian Cancer this publication. up will provide data that will clarify
Screening Trial (PLCO) (NCI) FOR FURTHER INFORMATION CONTACT: To further the long term effects of the
SUMMARY: Under the provisions of obtain a copy of the data collection screening on cancer incidence and
Section 3507(a)(1)(D) of the Paperwork plans and instruments or request more mortality for the four targeted cancers.
Reduction Act of 1995, the National information on the proposed project Further, demographic and risk factor
Institutes of Health (NIH), has submitted contact: Kelly Yu, Ph.D., Division of information may be used to analyze the
to the Office of Management and Budget Cancer Prevention, 9609 Medical Center differential effectiveness of cancer
(OMB) a request for review and Drive, Room 5E230, Rockville, MD screening in high versus low risk
approval of the information collection 20850 call non-toll-free number 240– individuals.
listed below. This proposed information 276–7041 or Email your request, OMB approval is requested for 3
collection was previously published in including your address to: years. There are no costs to respondents
the Federal Register on April 21, 2015 yuke@mail.nih.gov. Formal requests for other than their time. The total
(80 FR 22211), and allowed 60-days for additional plans and instruments must estimated annualized burden hours are
public comment. No public comments be requested in writing. 26,320.

ESTIMATED ANNUALIZED BURDEN HOURS
Average time
Number of Annual
Number of per response
Form name Type of respondents responses per burden
respondents (minutes/
respondent hours
hour)

Annual Study Update (ASU) Form ... Participants who complete the ASU 77,281 1 5/60 6,440
ASU Telephone Script ...................... Non Responders to the ASU ........... 3,091 1 5/60 258
Authorization to Release Medical Participants who report new cancers 2,700 1 3/60 135
Records.
Health Status Questionnaire (Fe- Female participants who complete 960 1 5/60 80
male) (HSQ). the HSQ.
Health Status Questionnaire (Male) Male participants who complete the 1,040 1 5/60 87
(HSQ). HSQ.
Medication Use Questionnaire Participants who complete the MUQ 77,281 1 15/60 19,320
(MUQ).

Dated: June 23, 2015. DEPARTMENT OF HEALTH AND Institute Special Emphasis Panel, July
Karla Bailey, HUMAN SERVICES 22, 2015, 11:00 a.m. to 04:00 p.m.,
mstockstill on DSK4VPTVN1PROD with NOTICES

NCI Project Clearance Liaison, National National Cancer Institute Shady Grove,
Institutes of Health. National Institutes of Health 9609 Medical Center Drive, 2W194,
[FR Doc. 2015–17340 Filed 7–14–15; 8:45 am] Rockville, MD, 20850 which was
National Cancer Institute; Amended published in the Federal Register on
BILLING CODE 4140–01–P
Notice of Meeting
June 23, 2015, 80 FR 35964.
Notice is hereby given of a change in The meeting notice is amended to
the meeting of the National Cancer change the date of the meeting from July

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Document Created: 2015-12-15 13:32:51
Document Modified: 2015-12-15 13:32:51

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 September 14, 2015.
Contact		Information Collection Clearance staff, [email protected] or (202) 690-6162.
FR Citation		80 FR 41507