Proposed Collection; 60-Day Comment Request; Generic Clearance to Conduct Formative Research (NIAID), 44631-44632 [2017-20367]
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asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://www.regulations.
gov and insert the docket number, found
in brackets in the heading of this
document, into the ‘‘Search’’ box and
follow the prompts and/or go to the
Dockets Management Staff, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single
copies of the guidance to the Office of
Good Clinical Practice (OGCP), Office of
Special Medical Programs, Office of
Medical Products and Tobacco, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993; or Division of
Policy and Assurances, Office for
Human Research Protections, 1101
Wootton Pkwy., Suite 200, Rockville,
MD 20852. Send one self-addressed
adhesive label to assist the office in
processing your requests. The guidance
may also be obtained by mail by calling
OGCP at 301–796–8340 or OHRP at
240–453–6900 or 866–447–4777. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Janet Donnelly, Office of Good Clinical
Practice, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
Rm. 5167, Silver Spring, MD 20993,
301–796–4187; or Irene Stith-Coleman,
Office for Human Research Protections,
1101 Wootton Pkwy., Suite 200,
Rockville, MD 20852, 240–453–6900.
SUPPLEMENTARY INFORMATION:
I. Background
OHRP and FDA are announcing the
availability of a guidance document
entitled ‘‘Minutes of Institutional
Review Board Meetings; Guidance for
Institutions and Institutional Review
Boards.’’ OHRP and FDA are providing
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recommendations on the type and
amount of information to include in
minutes.
To enhance human subject protection
and reduce regulatory burden, OHRP
and FDA have been actively working to
harmonize the Agencies’ regulatory
requirements and guidance for human
subject research. This guidance
document was developed as a part of
these efforts. In addition, on December
13, 2016, the 21st Century Cures Act
(Cures Act) (Pub. L. 114–255) was
signed into law. Title III, section 3023
of the Cures Act requires the Secretary
of HHS to harmonize differences
between the HHS human subject
regulations and FDA’s human subject
regulations. This guidance document is
consistent with the goals of section 3023
of the Cures Act.
In the Federal Register of November
5, 2015 (80 FR 68545), OHRP and FDA
announced the availability of the draft
guidance of the same title dated
November 2015. OHRP and FDA
received several comments on the draft
guidance, and those comments were
considered as the guidance was
finalized. Changes include modifying
certain recommendations for inclusion
of information in minutes when such
information may be addressed in other
IRB records. In addition, editorial
changes were made to improve clarity.
The guidance announced in this notice
finalizes the draft guidance dated
November 2015.
II. Significance of Guidance
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of OHRP and FDA on minutes
of IRB meetings. It does not establish
any rights for any person and is not
binding on OHRP, FDA, or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information referenced in this
guidance that are related to IRB
recordkeeping requirements under 21
CFR 56.115 have been approved under
OMB control numbers 0910–0755 and
0910–0130. The collections of
information referenced in this guidance
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44631
that are related to IRB recordkeeping
requirements under 45 CFR 46.115 have
been approved under OMB control
number 0990–0260.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/ScienceResearch/
SpecialTopics/RunningClinicalTrials/
GuidancesInformationSheetsand
Notices/ucm219433.htm, https://
www.hhs.gov/ohrp/regulations-andpolicy/guidance/alphabetical-list/
index.html, or https://www.regulations.
gov.
Dated: August 30, 2017.
Don Wright,
Acting Assistant Secretary for Health.
Dated: Sept. 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–20405 Filed 9–22–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Generic Clearance to
Conduct Formative Research (NIAID)
National Institutes of Health,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
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 Institute of Allergy and
Infectious Diseases (NIAID) will publish
periodic summaries of propose 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.
SUMMARY:
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Dione Washington, Health
Science Policy Analyst, Strategic
Planning and Evaluation Branch, 5601
Fishers Lane, Room 5F32, Rockville,
Maryland, 20892 or Email your request,
including your address to:
FOR FURTHER INFORMATION CONTACT:
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44632
Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices
washingtondi@niaid.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
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,
SUPPLEMENTARY 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: Generic
Clearance to Conduct Formative
Research (NIAID), 0925–NEW, National
Institute of Allergy and Infectious
Diseases (NIAID), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The purpose of this Generic
is for information collections to improve
research approaches and final product
development to identify emergent
infectious disease threats and
comorbidities related to the needs of
diverse audiences. The information to
be collected as part of this generic
clearance will allow the agency to make
appropriate adjustments in content and
methods used in developmental and
testing stages in order to improve
research approaches and final product
development.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
31,950.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Research method
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden in
hours
Focus Group Screeners ..................................................................................
Interview Screeners/Surveys ...........................................................................
Focus Groups ..................................................................................................
Pretesting .........................................................................................................
Dyad/Triad Interviews ......................................................................................
In-depth Interviews (IDI) ..................................................................................
Surveys ............................................................................................................
Patient questionnaires .....................................................................................
Market research ...............................................................................................
2,000
2,000
4,000
1,000
4,000
6,000
7,000
4,500
300
1
1
1
1
1
1
1
1
1
15/60
15/60
2
1
90/60
90/60
30/60
30/60
4
500
500
8,000
1,000
6,000
9,000
3,500
2,250
1,200
Total ..........................................................................................................
30,800
30,800
........................
31,950
Dated: August 31, 2017.
Brandie Taylor,
Project Clearance Liaison, NIAID, NIH.
FOR FURTHER INFORMATION CONTACT:
Dean Webster, Office of Response and
Recovery, Federal Emergency
Management Agency, 500 C Street SW.,
Washington, DC 20472, (202) 646–2833.
[FR Doc. 2017–20367 Filed 9–22–17; 8:45 am]
BILLING CODE 4140–01–P
The notice
of a major disaster declaration for the
Commonwealth of Puerto is hereby
amended to include the following areas
among those areas determined to have
been adversely affected by the event
declared a major disaster by the
President in his declaration of
September 10, 2017.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Internal Agency Docket No. FEMA–4336–
DR; Docket ID FEMA–2017–0001]
Puerto Rico; Amendment No. 2 to
Notice of a Major Disaster Declaration
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
AGENCY:
This notice amends the notice
of a major disaster declaration for the
Commonwealth of Puerto Rico (FEMA–
4336–DR), dated September 10, 2017,
and related determinations.
DATES: This amendment was issued
September 16, 2017.
SUMMARY:
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The municipalities of Aguas Buenas,
´
˜
Barranquitas, Bayamon, Camuy, Catano,
Ciales, Comerio, Hatillo, Jayuya, Las Piedras,
Quebradillas, Salinas, San Juan, Vega Baja,
and Yauco for Public Assistance.
The following Catalog of Federal Domestic
Assistance Numbers (CFDA) are to be used
for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora
Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034,
Disaster Unemployment Assistance (DUA);
97.046, Fire Management Assistance Grant;
97.048, Disaster Housing Assistance to
Individuals and Households In Presidentially
Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance—
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Disaster Housing Operations for Individuals
and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals
and Households—Other Needs; 97.036,
Disaster Grants—Public Assistance
(Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.
Brock Long,
Administrator, Federal Emergency
Management Agency.
[FR Doc. 2017–20444 Filed 9–22–17; 8:45 am]
BILLING CODE 9111–23–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Internal Agency Docket No. FEMA–4332–
DR; Docket ID FEMA–2017–0001]
Texas; Amendment No. 6 to Notice of
a Major Disaster Declaration
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
This notice amends the notice
of a major disaster declaration for the
SUMMARY:
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[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Notices]
[Pages 44631-44632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20367]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Generic Clearance to
Conduct Formative Research (NIAID)
AGENCY: National Institutes of Health, Department of Health and Human
Services.
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 Institute of Allergy and Infectious
Diseases (NIAID) will publish periodic summaries of propose 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: Dione
Washington, Health Science Policy Analyst, Strategic Planning and
Evaluation Branch, 5601 Fishers Lane, Room 5F32, Rockville, Maryland,
20892 or Email your request, including your address to:
[[Page 44632]]
washingtondi@niaid.nih.gov. 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: Generic Clearance to Conduct Formative
Research (NIAID), 0925-NEW, National Institute of Allergy and
Infectious Diseases (NIAID), National Institutes of Health (NIH).
Need and Use of Information Collection: The purpose of this Generic
is for information collections to improve research approaches and final
product development to identify emergent infectious disease threats and
comorbidities related to the needs of diverse audiences. The
information to be collected as part of this generic clearance will
allow the agency to make appropriate adjustments in content and methods
used in developmental and testing stages in order to improve research
approaches and final product development.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 31,950.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total annual
Research method respondents responses per response (in burden in
respondent hours) hours
----------------------------------------------------------------------------------------------------------------
Focus Group Screeners........................... 2,000 1 15/60 500
Interview Screeners/Surveys..................... 2,000 1 15/60 500
Focus Groups.................................... 4,000 1 2 8,000
Pretesting...................................... 1,000 1 1 1,000
Dyad/Triad Interviews........................... 4,000 1 90/60 6,000
In-depth Interviews (IDI)....................... 6,000 1 90/60 9,000
Surveys......................................... 7,000 1 30/60 3,500
Patient questionnaires.......................... 4,500 1 30/60 2,250
Market research................................. 300 1 4 1,200
---------------------------------------------------------------
Total....................................... 30,800 30,800 .............. 31,950
----------------------------------------------------------------------------------------------------------------
Dated: August 31, 2017.
Brandie Taylor,
Project Clearance Liaison, NIAID, NIH.
[FR Doc. 2017-20367 Filed 9-22-17; 8:45 am]
BILLING CODE 4140-01-P
