82 FR 44631 - Proposed Collection; 60-Day Comment Request; Generic Clearance to Conduct Formative Research (NIAID)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 184 (September 25, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 184 (September 25, 2017)
| Page Range | 44631-44632 | |
| FR Document | 2017-20367 |
[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)] [Notices] [Pages 44631-44632] From the Federal Register Online [www.thefederalregister.org] [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]] [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: 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
![Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices 44631
redacted/blacked out, will be available recommendations on the type and that are related to IRB recordkeeping
for public viewing and posted on amount of information to include in requirements under 45 CFR 46.115 have
https://www.regulations.gov. Submit minutes. been approved under OMB control
both copies to the Dockets Management To enhance human subject protection number 0990–0260.
Staff. If you do not wish your name and and reduce regulatory burden, OHRP
and FDA have been actively working to IV. Electronic Access
contact information to be made publicly
available, you can provide this harmonize the Agencies’ regulatory Persons with access to the Internet
information on the cover sheet and not requirements and guidance for human may obtain the document at https://
in the body of your comments and you subject research. This guidance www.fda.gov/ScienceResearch/
must identify this information as document was developed as a part of SpecialTopics/RunningClinicalTrials/
‘‘confidential.’’ Any information marked these efforts. In addition, on December GuidancesInformationSheetsand
as ‘‘confidential’’ will not be disclosed 13, 2016, the 21st Century Cures Act Notices/ucm219433.htm, https://
except in accordance with 21 CFR 10.20 (Cures Act) (Pub. L. 114–255) was www.hhs.gov/ohrp/regulations-and-
and other applicable disclosure law. For signed into law. Title III, section 3023 policy/guidance/alphabetical-list/
more information about FDA’s posting of the Cures Act requires the Secretary index.html, or https://www.regulations.
of comments to public dockets, see 80 of HHS to harmonize differences gov.
FR 56469, September 18, 2015, or access between the HHS human subject Dated: August 30, 2017.
the information at: https://www.gpo.gov/ regulations and FDA’s human subject
Don Wright,
fdsys/pkg/FR-2015-09-18/pdf/2015- regulations. This guidance document is
consistent with the goals of section 3023 Acting Assistant Secretary for Health.
23389.pdf.
of the Cures Act. Dated: Sept. 15, 2017.
Docket: For access to the docket to
read background documents or the In the Federal Register of November Anna K. Abram,
electronic and written/paper comments 5, 2015 (80 FR 68545), OHRP and FDA Deputy Commissioner for Policy, Planning,
received, go to https://www.regulations. announced the availability of the draft Legislation, and Analysis.
gov and insert the docket number, found guidance of the same title dated [FR Doc. 2017–20405 Filed 9–22–17; 8:45 am]
in brackets in the heading of this November 2015. OHRP and FDA BILLING CODE 4164–01–P
document, into the ‘‘Search’’ box and received several comments on the draft
follow the prompts and/or go to the guidance, and those comments were
Dockets Management Staff, 5630 Fishers considered as the guidance was DEPARTMENT OF HEALTH AND
Lane, Rm. 1061, Rockville, MD 20852. finalized. Changes include modifying HUMAN SERVICES
Submit written requests for single certain recommendations for inclusion
of information in minutes when such National Institutes of Health
copies of the guidance to the Office of
Good Clinical Practice (OGCP), Office of information may be addressed in other
IRB records. In addition, editorial Proposed Collection; 60-Day Comment
Special Medical Programs, Office of Request; Generic Clearance to
Medical Products and Tobacco, Food changes were made to improve clarity.
The guidance announced in this notice Conduct Formative Research (NIAID)
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103, finalizes the draft guidance dated AGENCY: National Institutes of Health,
Silver Spring, MD 20993; or Division of November 2015. Department of Health and Human
Policy and Assurances, Office for II. Significance of Guidance Services.
Human Research Protections, 1101 ACTION: Notice.
The guidance is being issued
Wootton Pkwy., Suite 200, Rockville,
consistent with FDA’s good guidance SUMMARY: In compliance with the
MD 20852. Send one self-addressed
practices regulation (21 CFR 10.115). requirement of the Paperwork
adhesive label to assist the office in
The guidance represents the current Reduction Act of 1995 to provide
processing your requests. The guidance
thinking of OHRP and FDA on minutes opportunity for public comment on
may also be obtained by mail by calling
of IRB meetings. It does not establish proposed data collection projects, the
OGCP at 301–796–8340 or OHRP at
any rights for any person and is not National Institute of Allergy and
240–453–6900 or 866–447–4777. See
binding on OHRP, FDA, or the public. Infectious Diseases (NIAID) will publish
the SUPPLEMENTARY INFORMATION section
You can use an alternative approach if periodic summaries of propose projects
for electronic access to the guidance
it satisfies the requirements of the to be submitted to the Office of
document.
applicable statutes and regulations. This Management and Budget (OMB) for
FOR FURTHER INFORMATION CONTACT: guidance is not subject to Executive review and approval.
Janet Donnelly, Office of Good Clinical Order 12866. DATES: Comments regarding this
Practice, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, III. Paperwork Reduction Act of 1995 information collection are best assured
Rm. 5167, Silver Spring, MD 20993, This guidance refers to previously of having their full effect if received
301–796–4187; or Irene Stith-Coleman, approved collections of information. within 60 days of the date of this
Office for Human Research Protections, These collections of information are publication.
1101 Wootton Pkwy., Suite 200, subject to review by the Office of FOR FURTHER INFORMATION CONTACT: To
Rockville, MD 20852, 240–453–6900. Management and Budget (OMB) under obtain a copy of the data collection
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUPPLEMENTARY INFORMATION: the Paperwork Reduction Act of 1995 plans and instruments, submit
(44 U.S.C. 3501–3520). The collections comments in writing, or request more
I. Background of information referenced in this information on the proposed project,
OHRP and FDA are announcing the guidance that are related to IRB contact: Dione Washington, Health
availability of a guidance document recordkeeping requirements under 21 Science Policy Analyst, Strategic
entitled ‘‘Minutes of Institutional CFR 56.115 have been approved under Planning and Evaluation Branch, 5601
Review Board Meetings; Guidance for OMB control numbers 0910–0755 and Fishers Lane, Room 5F32, Rockville,
Institutions and Institutional Review 0910–0130. The collections of Maryland, 20892 or Email your request,
Boards.’’ OHRP and FDA are providing information referenced in this guidance including your address to:
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![44632 Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices
washingtondi@niaid.nih.gov. Formal including the validity of the is for information collections to improve
requests for additional plans and methodology and assumptions used; (3) research approaches and final product
instruments must be requested in Ways to enhance the quality, utility, and development to identify emergent
writing. clarity of the information to be infectious disease threats and
collected; and (4) Ways to minimizes the comorbidities related to the needs of
SUPPLEMENTARY INFORMATION: Section burden of the collection of information diverse audiences. The information to
3506(c)(2)(A) of the Paperwork on those who are to respond, including be collected as part of this generic
Reduction Act of 1995 requires: written the use of appropriate automated, clearance will allow the agency to make
comments and/or suggestions from the electronic, mechanical, or other appropriate adjustments in content and
public and affected agencies are invited technological collection techniques or methods used in developmental and
to address one or more of the following other forms of information technology.
points: (1) Whether the proposed testing stages in order to improve
Proposed Collection Title: Generic
collection of information is necessary research approaches and final product
Clearance to Conduct Formative
for the proper performance of the development.
Research (NIAID), 0925–NEW, National
function of the agency, including Institute of Allergy and Infectious OMB approval is requested for 3
whether the information will have Diseases (NIAID), National Institutes of years. There are no costs to respondents
practical utility; (2) The accuracy of the Health (NIH). other than their time. The total
agency’s estimate of the burden of the Need and Use of Information estimated annualized burden hours are
proposed collection of information, Collection: The purpose of this Generic 31,950.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of Total annual
Number of burden per
Research method responses per burden in
respondents response
respondent hours
(in 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. FOR FURTHER INFORMATION CONTACT: Disaster Housing Operations for Individuals
Brandie Taylor, Dean Webster, Office of Response and and Households; 97.050 Presidentially
Recovery, Federal Emergency Declared Disaster Assistance to Individuals
Project Clearance Liaison, NIAID, NIH.
and Households—Other Needs; 97.036,
[FR Doc. 2017–20367 Filed 9–22–17; 8:45 am] Management Agency, 500 C Street SW.,
Disaster Grants—Public Assistance
BILLING CODE 4140–01–P
Washington, DC 20472, (202) 646–2833. (Presidentially Declared Disasters); 97.039,
SUPPLEMENTARY INFORMATION: The notice Hazard Mitigation Grant.
of a major disaster declaration for the Brock Long,
Commonwealth of Puerto is hereby Administrator, Federal Emergency
DEPARTMENT OF HOMELAND amended to include the following areas
SECURITY Management Agency.
among those areas determined to have [FR Doc. 2017–20444 Filed 9–22–17; 8:45 am]
Federal Emergency Management been adversely affected by the event
BILLING CODE 9111–23–P
Agency declared a major disaster by the
President in his declaration of
September 10, 2017. DEPARTMENT OF HOMELAND
[Internal Agency Docket No. FEMA–4336–
DR; Docket ID FEMA–2017–0001] The municipalities of Aguas Buenas, SECURITY
Barranquitas, Bayamón, Camuy, Cataño,
Puerto Rico; Amendment No. 2 to Ciales, Comerio, Hatillo, Jayuya, Las Piedras, Federal Emergency Management
Notice of a Major Disaster Declaration Quebradillas, Salinas, San Juan, Vega Baja, Agency
and Yauco for Public Assistance.
AGENCY: Federal Emergency The following Catalog of Federal Domestic [Internal Agency Docket No. FEMA–4332–
Management Agency, DHS. Assistance Numbers (CFDA) are to be used DR; Docket ID FEMA–2017–0001]
asabaliauskas on DSKBBXCHB2PROD with NOTICES
ACTION: Notice. for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Texas; Amendment No. 6 to Notice of
SUMMARY: This notice amends the notice Brown Fund; 97.032, Crisis Counseling; a Major Disaster Declaration
of a major disaster declaration for the 97.033, Disaster Legal Services; 97.034,
Disaster Unemployment Assistance (DUA);
AGENCY: Federal Emergency
Commonwealth of Puerto Rico (FEMA– Management Agency, DHS.
4336–DR), dated September 10, 2017, 97.046, Fire Management Assistance Grant;
97.048, Disaster Housing Assistance to ACTION: Notice.
and related determinations. Individuals and Households In Presidentially
DATES: This amendment was issued Declared Disaster Areas; 97.049, SUMMARY: This notice amends the notice
September 16, 2017. Presidentially Declared Disaster Assistance— of a major disaster declaration for the
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Document Created: 2018-10-24 14:44:24
Document Modified: 2018-10-24 14:44:24
| 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 regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. | |
| 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, | |
| FR Citation | 82 FR 44631 |
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