65408 Federal Register / Vol. 79, No. 213 / Tuesday, November 4, 2014 / Notices 

Network (FoodNet) Sites According to 

Age, Pregnancy, and Ethnicity,’’ Clinical 

Infectious Diseases, 54(S5): S401–410, 

2012. 

4. Goulet, V., C. Hedberg, A. Le Monnier, et 

al. ‘‘Increasing Incidence of Listeriosis in 

France and other European Countries,’’ 

Emerging Infectious Diseases, 14(5): 734– 

740, 2008. 

5. Mun ̃ oz, P., L. Rojas, E. Bunsow, et al. 

‘‘Listeriosis: An Emerging Public Health 

Problem Especially Among the Elderly,’’ 

Journal of Infection, 64: 19–33, 2012. 

Dated: October 29, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–26144 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–2008–N–0312] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Extralabel Drug 

Use in Animals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. 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 solicits comments on 

the reporting requirements associated 

with extralabel drug use in animals. 

DATES: Submit 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, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, 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. 

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. 

Extralabel Drug Use in Animals—21 

CFR 530 (OMB Control Number—0910– 

0325)—Extension 

The Animal Medicinal Drug Use 

Clarification Act of 1994 allows a 

veterinarian to prescribe the extralabel 

use of approved new animal drugs. 

Also, it permits FDA, if it finds that 

there is a reasonable probability that the 

extralabel use of an animal drug may 

present a risk to the public health, to 

establish a safe level for a residue from 

the extralabel use of the drug, and to 

require the development of an analytical 

method for the detection of residues 

above that established safe level. 

Although to date we have not 

established a safe level for a residue 

from the extralabel use of any new 

animal drug and, therefore, have not 

required the development of analytical 

methodology, we believe that there may 

be instances when analytical 

methodology will be required. We are, 

therefore, estimating the reporting 

burden based on two methods being 

required annually. The requirement to 

establish an analytical method may be 

fulfilled by any interested person. We 

believe that the sponsor of the drug will 

be willing to develop the method in 

most cases. Alternatively, FDA, the 

sponsor, and perhaps a third party may 

cooperatively arrange for method 

development. The respondents may be 

sponsors of new animal drugs, State, or 

Federal Agencies, academia, or 

individuals. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

530.22(b) .............................................................................. 2 1 2 4,160 8,320 

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


rmajette on DSK3VPTVN1PROD with NOTICES
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