Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices 51425 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0403] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Substantiation for 

Dietary Supplement Claims Made 

Under the Federal Food, Drug, and 

Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection provisions of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) and the guidance entitled 

‘‘Guidance for Industry: Substantiation 

for Dietary Supplement Claims Made 

Under Section 403(r)(6) of the Federal 

Food, Drug, and Cosmetic Act.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 5, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before January 5, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of January 5, 2018. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

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–N–0403 for ‘‘Substantiation for 

Dietary Supplement Claims Made Under 

the Federal Food, Drug, and Cosmetic 

Act.’’ Received comments, those filed in 

a timely manner (see ADDRESSES), 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. 

FOR FURTHER INFORMATION CONTACT: Ila 

Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 


Pmangrum on DSK3GDR082PROD with NOTICES
51426 Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’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 minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Substantiation for Dietary Supplement 

Claims Made Under the Federal Food, 

Drug, and Cosmetic Act—21 U.S.C. 

343(r)(6) 

OMB Control Number 0910–0626— 

Extension 

This information collection supports 

Agency regulations and associated 

guidance. Specifically, section 403(r)(6) 

of the FD&C Act (21 U.S.C. 343(r)(6)) 

requires that a manufacturer of a dietary 

supplement making a nutritional 

deficiency, structure/function, or 

general well-being claim have 

substantiation that the claim is truthful 

and not misleading. A nutritional 

deficiency claim states a benefit related 

to a classical nutrient deficiency disease 

and states how often the disease occurs 

in the United States. A structure/ 

function claim describes the role of a 

nutrient or dietary ingredient intended 

to affect the structure or function in 

humans or characterizes how a nutrient 

or dietary ingredient acts to maintain 

such structure or function. A general 

well-being claim describes general wellbeing from consumption of a nutrient or 

dietary ingredient. 

The guidance document entitled 

‘‘Substantiation for Dietary Supplement 

Claims Made Under Section 403(r)(6) of 

the Federal Food, Drug, and Cosmetic 

Act’’ provides our recommendations to 

manufacturers about the amount, type, 

and quality of evidence they should 

have to substantiate a claim under 

section 403(r)(6) of the FD&C Act. The 

guidance does not discuss the types of 

claims that can be made concerning the 

effect of a dietary supplement on the 

structure or function of the body, nor 

does it discuss criteria to determine 

when a statement about a dietary 

supplement is a disease claim. The 

guidance document is intended to assist 

manufacturers in their efforts to comply 

with section 403(r)(6) of the FD&C Act. 

Persons with access to the internet may 

obtain the guidance at https://

www.fda.gov/FoodGuidances. 

Dietary supplement manufacturers 

collect the necessary substantiating 

information for their product as 

required by section 403(r)(6) of the 

FD&C Act. The guidance provides 

information to manufacturers to assist 

them in doing so. The recommendations 

contained in the guidance are voluntary. 

Dietary supplement manufacturers will 

only need to collect information to 

substantiate their product’s nutritional 

deficiency, structure/function, or 

general well-being claim if they choose 

to place a claim on their product’s label. 

The standard discussed in the 

guidance for substantiation of a claim 

on the labeling of a dietary supplement 

is consistent with standards set by the 

Federal Trade Commission for dietary 

supplements and other health-related 

products that the claim be based on 

competent and reliable scientific 

evidence. This evidence standard is 

broad enough that some dietary 

supplement manufacturers may only 

need to collect peer-reviewed scientific 

journal articles to substantiate their 

claims; other dietary supplement 

manufacturers whose products have 

properties that are less well documented 

may have to conduct studies to build a 

body of evidence to support their 

claims. It is unlikely that a dietary 

supplement manufacturer will attempt 

to make a claim when the cost of 

obtaining the evidence to support the 

claim outweighs the benefits of having 

the claim on the product’s label. It is 

likely that manufacturers will seek 

substantiation for their claims in the 

scientific literature. 

The time it takes to assemble the 

necessary scientific information to 

support their claims depends on the 

product and the claimed benefits. If the 

product is one of several on the market 

making a particular claim for which 

there is adequate publicly available and 

widely established evidence supporting 

the claim, then the time to gather 

supporting data will be minimal; if the 

product is the first of its kind to make 

a particular claim or the evidence 

supporting the claim is less publicly 

available or not widely established, then 

gathering the appropriate scientific 

evidence to substantiate the claim will 

be more time consuming. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Claim type Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total 

hours 

Widely known, established .................................................. 667 1 667 44 29,348 

Preexisting, not widely established ...................................... 667 1 667 120 80,040 

Novel .................................................................................... 667 1 667 120 80,040 

Total .............................................................................. ........................ ........................ ........................ ........................ 189,428 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We have retained the currently 

approved burden estimate for the 

information collection. Based on our 

experience with the collection, we 

estimate that it will take 44 hours to 

assemble information needed to 

substantiate a claim on a particular 

dietary supplement when the claim is 

widely known and established. We 

believe it will take closer to 120 hours 

to assemble supporting scientific 

information when the claim is novel or 

when the claim is preexisting but the 

scientific underpinnings of the claim are 

not widely established. These are claims 

that may be based on emerging science, 

where conducting literature searches 

and understanding the literature takes 

time. It is also possible that references 

for claims made for some dietary 

ingredients or dietary supplements may 

primarily be found in foreign journals 

and in foreign languages or in the older, 

classical literature where it is not 

available on computerized literature 

databases or in the major scientific 

reference databases, such as the 

National Library of Medicine’s literature 

database, all of which increases the time 

of obtaining substantiation. 


Pmangrum on DSK3GDR082PROD with NOTICES
Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices 51427 

In the Federal Register of January 6, 

2000 (65 FR 1000), we published a final 

rule (the ‘structure/function final rule) 

on statements made for dietary 

supplements concerning the effect of the 

product on the structure or function of 

the body. In that final rule, we estimated 

that there were 29,000 dietary 

supplement products marketed in the 

United States (65 FR 1000 at 1045). 

Assuming that the flow of new products 

is 10 percent per year, then 2,900 new 

dietary supplement products will come 

on the market each year. The structure/ 

function final rule estimated that about 

69 percent of dietary supplements have 

a claim on their labels, most probably a 

structure/function claim (65 FR 1000 at 

1046). Therefore, we assume that 

supplement manufacturers will need 

time to assemble the evidence to 

substantiate each of the 2,001 claims 

(2,900 × 69 percent) made each year. If 

we assume that the 2,001 claims are 

equally likely to be preexisting widely 

established claims, novel claims, or 

preexisting claims that are not widely 

established, then we can expect 667 of 

each of these types of claims to be 

substantiated per year. Table 1 of this 

document shows that the annual burden 

hours associated with assembling 

evidence for claims is 189,428 (the sum 

of 667 × 44 hours, 667 × 120 hours, and 

667 × 120 hours). 

Dated: October 31, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24123 Filed 11–3–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Mental Health Special Emphasis Panel; 

NIMH HIV/AIDS Review (P30, T32). 

Date: November 28, 2017. 

Time: 12:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Virtual 

Meeting). 

Contact Person: David W. Miller, Ph.D., 

Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, NIH, Neuroscience Center, 

6001 Executive Blvd, Room 6140, MSC 9608, 

Bethesda, MD 20892–9608, 301–443–9734, 

millerda@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.242, Mental Health Research 

Grants; National Institutes of Health, HHS) 

Dated: October 31, 2017. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–24034 Filed 11–3–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Respiratory Sciences. 

Date: November 15–16, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Sara Ahlgren, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, RM 4136, 

Bethesda, MD 20892, 301–435–0904, 

sara.ahlgren@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Blood 

Disorders. 

Date: November 15, 2017. 

Time: 10:00 a.m. to 11:00 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Luis Espinoza, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4140, 

MSC 7814, Bethesda, MD 20892, 301–435– 

0952, espinozala@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Neurological, Neuropsychological 

Disorders and Aging. 

Date: November 17, 2017. 

Time: 10:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Samuel C. Edwards, Ph.D., 

Chief, Brain Disorders and Clinical 

Neuroscience, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 5210, MSC 7846, Bethesda, MD 

20892, (301) 435–1246, edwardss@

csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: AIDS and AIDS Related Research. 

Date: November 28, 2017. 

Time: 12:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Mark P. Rubert, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5218, 

MSC 7852, Bethesda, MD 20892, 301–435– 

1775, rubertm@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: Dermatology, Rheumatology and 

Inflammation. 

Date: November 29, 2017. 

Time: 10:30 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

Contact Person: Rajiv Kumar, Ph.D., Chief, 

MOSS IRG, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 4216, MSC 7802, Bethesda, MD 

20892, 301–435–1212, kumarra@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: HIV/AIDS Innovative Research 

Applications. 

Date: November 30, 2017. 

Time: 1:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting) 

Contact Person: Jose H. Guerrier, Ph.D., 

Scientific Review Officer, Center for 


Pmangrum on DSK3GDR082PROD with NOTICES