Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices 44629 

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– 

2017–D–0121 for ‘‘Compliance Policy 

for Required Warning Statements on 

Small-Packaged Cigars.’’ 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 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 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Center for 

Tobacco Products, Food and Drug 

Administration, Document Control 

Center, Bldg. 71, Rm. G335, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002. Send one self-addressed 

adhesive label to assist that office in 

processing your request or include a Fax 

number to which the guidance 

document may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

FOR FURTHER INFORMATION CONTACT: 

Deirdre Jurand, Center for Tobacco 

Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Document Control Center, Bldg. 

71, Rm. G335, Silver Spring, MD 20993– 

0002, 1–877–287–1373, AskCTP@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Compliance Policy for Required 

Warning Statements on Small-Packaged 

Cigars.’’ 

On June 22, 2009, the Family 

Smoking Prevention and Tobacco 

Control Act (Tobacco Control Act) (Pub. 

L. 111–31) was signed into law. The 

Tobacco Control Act granted FDA the 

authority to regulate the manufacture, 

marketing, and distribution of cigarettes, 

cigarette tobacco, roll-your-own tobacco 

(RYO), and smokeless tobacco products 

to protect the public health and to 

reduce tobacco use by minors. 

The Tobacco Control Act also gave 

FDA the authority to issue a regulation 

deeming other products that meet the 

statutory definition of a tobacco product 

to be subject to Chapter IX of the FD&C 

Act (section 901(b) of the FD&C Act). On 

May 10, 2016, FDA issued that rule, 

extending FDA’s tobacco product 

authority to cigars, among other 

products (81 FR 28973). Among the 

requirements that now apply to cigars 

are health warning statements 

prescribed under section 906(d) of the 

FD&C Act, which permits restrictions on 

the sale and distribution of tobacco 

products that are ‘‘appropriate for the 

protection of the public health.’’ The 

rule specifies the health warning 

statements that must be displayed on 

cigar packaging and where those 

statements must be placed, among other 

requirements. 

The guidance discusses FDA’s 

compliance policy for cigars with 

packaging too small or otherwise unable 

to accommodate the warning statements 

and specifications required under the 

regulation. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on its compliance 

policy for cigars in small packaging. It 

does not establish any rights for any 

person and is not binding on 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 also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 1143 have been approved 

under 0910–0768. 

IV. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

guidance at either https://

www.regulations.gov or https://

www.fda.gov/TobaccoProducts/ 

Labeling/RulesRegulationsGuidance/ 

default.htm. 

Dated: September 20, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20426 Filed 9–22–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Service 

Administration 

National Advisory Council on Migrant 

Health 

AGENCY: Health Resources and Service 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, notice 

is hereby given that a National Advisory 

Council on Migrant Health (NACMH/ 

Council) meeting has been scheduled. 

This meeting will be open to the public. 

The agenda for the NACMH meeting can 

be obtained by contacting the 

Designated Federal Officer (DFO) or 

accessing the Council Web site: https:// 

bphc.hrsa.gov/qualityimprovement/ 

strategicpartnerships/nacmh/ 

index.html. 

DATES: The meeting will be held on 

November 7, 2017, 8:30 a.m.to 5:00 p.m. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
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