Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices 44631 

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/2015- 

23389.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 

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 

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) 

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: 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
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. 

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

Research method Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden 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. 

Brandie Taylor, 

Project Clearance Liaison, NIAID, NIH. 

[FR Doc. 2017–20367 Filed 9–22–17; 8:45 am] 

BILLING CODE 4140–01–P 

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 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: 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. 

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. 

SUPPLEMENTARY INFORMATION: 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. 

The municipalities of Aguas Buenas, 

Barranquitas, Bayamo ́n, Camuy, Catan ̃ o, 

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— 

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 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This notice amends the notice 

of a major disaster declaration for the 


asabaliauskas on DSKBBXCHB2PROD with NOTICES