44630 Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices 

ET, and November 8, 2017, 8:30 a.m. to 

5:00 p.m. ET. 

ADDRESSES: The address for the meeting 

is Doubletree by Hilton Raleigh 

Brownstone-University, 1707 

Hillsborough Street, Raleigh, NC 27605. 

Phone: (919) 828–0811. 

FOR FURTHER INFORMATION CONTACT: All 

requests for information regarding the 

NACMH should be sent to Esther Paul, 

DFO, NACMH, HRSA, in one of three 

ways: (1) By mail to: Esther Paul, Office 

of Policy and Program Development, 

Bureau of Primary Health Care, HRSA, 

5600 Fishers Lane, 16N38B, Rockville, 

Maryland 20857; (2) by phone: (301) 

594–4300; or (3) by email: epaul@

hrsa.gov. 

SUPPLEMENTARY INFORMATION: The 

NACMH is a non-discretionary advisory 

body mandated by the Public Health 

Service (PHS) Act, Title 42 U.S.C. 218, 

to advise, consult with, and make 

recommendations to the Secretary of 

HHS and the Administrator of HRSA 

regarding the organization, operation, 

selection, and funding of migrant health 

centers and other entities funded under 

section 330(g) of the PHS Act (42 U.S.C. 

254b). The NACMH Charter requires 

that the Council meet at least twice per 

year to discuss services and issues 

related to the health of migrant and 

seasonal agricultural workers and their 

families and to formulate their 

recommendations to the HHS Secretary 

and HRSA Administrator. 

Agenda: The agenda includes an 

overview of the Council’s general 

business activities. The Council will 

also hear presentations from a federal 

official and experts on issues facing 

agricultural workers, including the 

status of agricultural worker health at 

the local and national levels. In 

addition, the Council will hold a public 

hearing where migratory and seasonal 

agricultural workers will testify 

regarding matters affecting them. This 

hearing is scheduled for Tuesday, 

November 7, 2017 from 1:30 p.m. to 

5:00 p.m. at the Doubletree by Hilton 

Raleigh Brownstone-University. Agenda 

items are subject to change as priorities 

indicate. 

Public Participation: Members of the 

public will not be able to provide oral 

comments during the meeting. Please 

provide any written questions or 

comments for the NACMH to the DFO 

by October 27, 2017, using the address, 

phone number, or email provided 

above. Individuals who plan to attend 

the meeting and need special assistance, 

such as sign language interpretation or 

other reasonable accommodations, 

should notify the DFO at least 10 days 

prior to the meeting. 

Amy McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2017–20422 Filed 9–22–17; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Docket No. FDA–2015–D–3638] 

Minutes of Institutional Review Board 

Meetings; Guidance for Institutions 

and Institutional Review Boards; 

Availability 

AGENCY: The Office for Human Research 

Protections, Office of the Assistant 

Secretary for Health, Office of the 

Secretary, and the Food and Drug 

Administration, HHS. 

ACTION: Notice of availability. 

SUMMARY: The Office for Human 

Research Protections (OHRP), Office of 

the Assistant Secretary for Health, and 

the Food and Drug Administration 

(FDA) are announcing the availability of 

a guidance entitled ‘‘Minutes of 

Institutional Review Board Meetings; 

Guidance for Institutions and 

Institutional Review Boards.’’ The 

guidance is intended for institutions 

and Institutional Review Boards (IRBs) 

that are responsible for the review and 

oversight of human subject research 

conducted or supported by the U.S. 

Department of Health and Human 

Services (HHS) or regulated by FDA. 

The purpose of the guidance is to assist 

institutions and IRBs in preparing and 

maintaining minutes of IRB meetings 

(also referred to in the guidance as 

minutes) that meet the regulatory 

requirements for minutes set forth in 

FDA and HHS regulations. The 

guidance also provides general 

recommendations on the type and 

amount of information to be included in 

the minutes. The guidance announced 

in this notice finalizes the draft 

guidance of the same title dated 

November 2015. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 25, 2017. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2015–D–3638 for ‘‘Minutes of 

Institutional Review Board Meetings; 

Guidance for Institutions and 

Institutional Review Boards.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the office of Dockets Management 

Staff between 9 a.m. and 4 p.m., 

Monday through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
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: 


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