45454 Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0376] 

Policy Regarding Quantitative Labeling 

of Dietary Supplements Containing 

Live Microbials; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Policy 

Regarding Quantitative Labeling of 

Dietary Supplements Containing Live 

Microbials.’’ The draft guidance, when 

finalized, will advise firms that 

manufacturer, market, or distribute 

dietary supplements of FDA’s intent to 

exercise enforcement discretion if a firm 

wishes to specify the amount of a live 

microbial in colony forming units 

(CFUs) in addition to the currently 

required unit of measure (milligrams) in 

the Supplement Facts label. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 6, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time 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– 

2011–D–0376 for ‘‘Policy Regarding 

Quantitative Labeling of Dietary 

Supplements Containing Live 

Microbials: Draft Guidance for 

Industry.’’ 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 the draft guidance to the Office 

of Dietary Supplement Programs, Center 

for Food Safety and Applied Nutrition, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740. 

Send two self-addressed adhesive labels 

to assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Steven Tave, Center for Food Safety and 

Applied Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2878. 

SUPPLEMENTARY INFORMATION:

I. Background 

We are announcing the availability of 

a draft guidance for industry entitled 

‘‘Policy Regarding Quantitative Labeling 

of Dietary Supplements Containing Live 

Microbials.’’ We are issuing the draft 

guidance consistent with our good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the current 

thinking of FDA on this topic. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternate approach if it 

satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

The draft guidance, when finalized, 

would advise firms that manufacture, 

market, or distribute dietary 

supplements of FDA’s intent to exercise 

enforcement discretion with respect to 

declaration of live microbial quantity in 

CFUs, in addition to the quantitative 

amount by weight declaration required 

by regulation, within the Supplement 

Facts label of dietary supplements 

containing live microbials, provided 

that certain conditions are met. 

II. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/FoodGuidances or 

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


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Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices 45455 

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

III. Paperwork Reduction Act 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

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 in 21 CFR 101.36 have 

been approved under OMB control 

number 0910–0381. 

Dated: August 31, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–19367 Filed 9–6–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Charter Renewal for the Advisory 

Committee on Organ Transplantation 

AGENCY: Health Resources and Services 

Administration (HRSA), The 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of charter renewal. 

SUMMARY: HHS is hereby giving notice 

that the Advisory Committee on Organ 

Transplantation (ACOT) has been 

rechartered. The effective date of the 

renewed charter is August 31, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Robert Walsh, Executive Secretary, 

Advisory Committee on Organ 

Transplantation, Health Resources and 

Services Administration, Department of 

Health and Human Services, Room 

08W60, 5600 Fishers Lane, Rockville, 

Maryland 20857. Phone: (301) 443– 

6839; fax: (301) 594–6095; email: 

rwalsh@hrsa.gov. 

SUPPLEMENTARY INFORMATION: The ACOT 

was authorized by section 121.12 of the 

amended Final Rule of the Organ 

Procurement and Transplantation 

Network (OPTN) (42 CFR part 121). In 

accordance with the Federal Advisory 

Committee Act (FACA), Public Law 92– 

463, it was initially chartered on 

September 1, 2000, and was renewed at 

the appropriate intervals. 

The ACOT provides advice to the 

Secretary on all aspects of organ 

donation, procurement, allocation, and 

transplantation, and on such other 

matters that the Secretary determines. 

The recommendations of the ACOT will 

facilitate the Department’s efforts to 

oversee the Organ Procurement and 

Transplantation Network (OPTN), as set 

forth in the National Organ Transplant 

Act of 1984, as amended. 

The charter renewal for the ACOT 

was approved on August 31, 2018, 

which will also stand as the filing date. 

Renewal of the ACOT charter gives 

authorization for the Committee to 

operate until August 31, 2020. 

A copy of the ACOT charter is 

available on the ACOT website at: 

http://www.organdonor.gov/legislation/ 

advisory.html. A copy of the charter can 

also be obtained by accessing the FACA 

database that is maintained by the 

Committee Management Secretariat 

under the General Services 

Administration. The website for the 

FACA database is http://

www.facadatabase.gov/. 

Amy P. McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2018–19454 Filed 9–6–18; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; Responsibility of 

Applicants for Promoting Objectivity in 

Research for Which Public Health 

Service (PHS) Funding is Sought and 

Responsible Prospective Contractors 

(Office of the Director) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

National Institutes of Health (NIH) has 

submitted to the Office of Management 

and Budget (OMB) a request for review 

and approval of the information 

collection listed below. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 30-days of the date of this 

publication. 

ADDRESSES: Written comments and/or 

suggestions regarding the item(s) 

contained in this notice, especially 

regarding the estimated public burden 

and associated response time, should be 

directed to the: Office of Management 

and Budget, Office of Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Ms. Diane Dean, 

Director, Division of Grants Compliance 

and Oversight, Office of Policy for 

Extramural Research Administration, 

Office of Extramural Research, National 

Institutes of Health, 6705 Rockledge 

Drive, Room 3525, Bethesda, MD 20892, 

or call non-toll-free number (301) 435– 

0930 or Email your request, including 

your address to: deand@

od31em1.od.nih.gov. 

SUPPLEMENTARY INFORMATION: This 

proposed information collection was 

previously published in the Federal 

Register on March 16, 2018, (FR 83 

pages 11763–11765) and allowed 60 

days for public comment. One public 

comment was received. The purpose of 

this notice is to allow an additional 30 

days for public comment. 

The National Institutes of Health may 

not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

displays a currently valid OMB control 

number. 

In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. 

Proposed Collection: Responsibility of 

Applicants for Promoting Objectivity in 

Research for which Public Health 

Service (PHS) Funding is Sought 42 CFR 

part 50 subpart F and Responsible 

Prospective Contractors 45 CFR part 94, 

0925–0417, expiration date 2/28/2015, 

REINSTATEMENT WITHOUT 

CHANGE, Office of Policy for 

Extramural Research Administration 

(OPERA), Office of Extramural Research 

(OER), National Institutes of Health 

(NIH). 

Need and Use of Information 

Collection: This request is for Office of 

Management and Budget (OMB) 

approval of a Reinstatement Without 

Change of a currently approved 

collection resulting from the 

development of revised regulations 

regarding the Responsibility of 

Applicants for Promoting Objectivity in 

Research for which PHS Funding is 

Sought (42 CFR part 50, subpart F) and 

Responsible Prospective Contractors (45 

CFR part 94). The purpose of these 

regulations is to promote objectivity in 

research by requiring institutions to 

establish standards to ensure that there 

is no reasonable expectation that the 

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