Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices 65409 

Dated: October 29, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26143 Filed 11–3–14; 8:45 am] 

BILLING CODE 4164–01–P 

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 we) is 

announcing an opportunity for public 

comment on our proposed collection of 

certain information. Under the 

Paperwork Reduction Act of 1995 (the 

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 invites 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, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 1350 Piccard 

Dr., PI50–400B, Rockville, MD 20850, 

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 

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, we are publishing notice of 

the proposed collection of information 

set forth in this document. 

With respect to the following 

collection of information, we invite 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of our functions, including whether the 

information will have practical utility; 

(2) the accuracy of our 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 

Section 403(r)(6) of the Federal Food, 

Drug, and Cosmetic Act (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. Under 

section 403(r)(6)(A) of the FD&C Act, 

such a statement is one that ‘‘claims a 

benefit related to a classical nutrient 

deficiency disease and discloses the 

prevalence of such disease in the United 

States, describes the role of a nutrient or 

dietary ingredient intended to affect the 

structure or function in humans, 

characterizes the documented 

mechanism by which a nutrient or 

dietary ingredient acts to maintain such 

structure or function, or describes 

general well-being from consumption 

for 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 http://

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 


rmajette on DSK3VPTVN1PROD with NOTICES
65410 Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices 

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. 

We estimate 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 

Pre-existing, not widely established .................................... 667 1 667 120 80,040 

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

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

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

We assume 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 pre-existing 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. 

In the Federal Register of January 6, 

2000 (65 FR 1000), we published a 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 pre-existing 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 28, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26142 Filed 11–3–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1698] 

Food and Drug Administration 

Activities for Patient Participation in 

Medical Product Discussions; 

Establishment of a Public Docket 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; Establishment of docket; 

Request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

establishment of a public docket for 

comments on FDA activities performed 

under the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA), Patient Participation in 

Medical Product Discussions. This 

notice announces FDA’s intent to gather 

input from stakeholders on strategies to 

obtain the views of patients during the 

medical product development process 

and ways to consider patients’ 

perspectives during regulatory 

discussions. This notice provides 

background on ongoing patient 

engagement activities, so that 

stakeholders can consider both current 

and new activities that involve patient 

participation and perspectives during 

medical product regulatory discussions. 

DATES: Although FDA welcomes 

comments at any time, to help FDA 

address issues related to Patient 

Participation in Medical Products 

Discussions in a timely fashion, 

comments should be submitted by 

December 4, 2014. 

ADDRESSES: Submit electronic 

comments to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Andrea Furia-Helms, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5319, Silver Spring, 

MD 20993–0002, Andrea.Furia@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 9, 2012, the President signed 

into law FDASIA (Pub. L. 112–144). 

FDASIA expands the FDA’s authorities 

and strengthens the Agency’s ability to 

safeguard and advance public health in 

several areas including increasing 

stakeholder involvement in FDA 

regulatory processes. Specifically, 

section 1137 of FDASIA directs the 

Secretary of HHS to ‘‘develop and 

implement strategies to solicit the views 

of patients during the medical product 

development process and consider the 

perspectives of patients during 

regulatory discussions, including by— 

(1) fostering participation of a patient 

representative who may serve as a 

special government employee in 


rmajette on DSK3VPTVN1PROD with NOTICES