Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Notices 25749 

[FR Doc. 08–1213 Filed 5–1–08; 4:00 pm] 

BILLING CODE 4120–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0272] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry: Notification of a Health Claim 

or Nutrient Content Claim Based on an 

Authoritative Statement of a Scientific 

Body 

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 collection of information associated 

with the submission of notifications of 

health claims or nutrient content claims 

based on authoritative statements of 

scientific bodies of the U.S. 

Government. 

DATES: Submit written or electronic 

comments on the collection of 

information by July 7, 2008. 

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: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration,5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

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. 

Guidance for Industry: Notification of a 

Health Claim or Nutrient Content Claim 

Based on an Authoritative Statement of 

a Scientific Body (OMB Control 

Number 0910–0374)—Extension 

Section 403(r)(2)(G) and (r)(3)(C) of 

the Federal Food, Drug and Cosmetic 

Act (the act) (21 U.S.C. 343(r)(2)(G) and 

(r)(3)(C)), as amended by the FDA 


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25750 Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Notices 

Modernization Act of 1997, provides 

that any person may market a food 

product whose label bears a nutrient 

content claim or a health claim that is 

based on an authoritative statement of a 

scientific body of the U.S. Government 

or the National Academy of Sciences 

(NAS). Under this section of the act, a 

person that intends to use such a claim 

must submit a notification of its 

intention to use the claim 120 days 

before it begins marketing the product 

bearing the claim. In the Federal 

Register of June 11, 1998 (63 FR 32102), 

FDA announced the availability of a 

guidance entitled ‘‘Guidance for 

Industry: Notification of a Health Claim 

or Nutrient Content Claim Based on an 

Authoritative Statement of a Scientific 

Body.’’ The guidance provides the 

agency’s interpretation of terms central 

to the submission of a notification and 

the agency’s views on the information 

that should be included in the 

notification. The agency believes that 

the guidance will enable persons to 

meet the criteria for notifications that 

are established in section 403(r)(2)(G) 

and (r)(3)(C) of the act. In addition to the 

information specifically required by the 

act to be in such notifications, the 

guidance states that the notifications 

should also contain information on 

analytical methodology for the nutrient 

that is the subject of a claim based on 

an authoritative statement. FDA intends 

to review the notifications the agency 

receives to ensure that they comply with 

the criteria established by the act. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.— ESTIMATED ANNUAL REPORTING BURDEN1

Section of the Act/Basis of Burden No. of 

Respondents 

Annual 

Frequency per 

Response 

Total Annual 

Responses 

Hours Per 

Response Total Hours 

403(r)(2)(G) (nutrient content claims) 1 1 1 250 250 

403(r)(2)(C) (health claims) 2 1 2 450 900 

Guidance for notifications 3 1 3 1 3 

Total 1,153 

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

These estimates are based on FDA’s 

experience with health claims, nutrient 

content claims, and other similar 

notification procedures that fall under 

the agency’s jurisdiction. FDA estimates 

that it will receive one nutrient content 

claim notification and two health claim 

notifications per year. 

Section 403(r)(2)(G) and 403(r)(3)(C) 

of the act requires that the notification 

include the exact words of the claim, a 

copy of the authoritative statement, a 

concise description of the basis upon 

which such person relied for 

determining that this is an authoritative 

statement as outlined in the act, and a 

balanced representation of the scientific 

literature relating to the relationship 

between a nutrient and a disease or 

health-related condition to which a 

health claim refers or to the nutrient 

level to which the nutrient content 

claim refers. This balanced 

representation of the scientific literature 

is expected to include a bibliography of 

the scientific literature on the topic of 

the claim and a brief, balanced account 

or analysis of how this literature either 

supports or fails to support the 

authoritative statement. 

Since the claims are based on 

authoritative statements of a scientific 

body of the Federal government or NAS, 

FDA believes that the information that 

is required by the act to be submitted 

with a notification will be readily 

available to a respondent. However, the 

respondent will have to collect and 

assemble that information. Based on 

communications with firms that have 

submitted notifications, FDA estimates 

that it will take a respondent 250 hours 

to collect and assemble the information 

required by the statute for nutrient 

content claim notifications and 450 

hours to collect and assemble the 

information required by the statute for 

health claim notifications. 

Under the guidance, notifications 

should also contain information on 

analytical methodology for the nutrient 

that is the subject of a claim based on 

an authoritative statement. The 

guidance applies to both nutrient 

content claim and health claim 

notifications. FDA has determined that 

this information should be readily 

available to a respondent and, thus, the 

agency estimates that it will take a 

respondent 1 hour to incorporate the 

information into the notification. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: May 1, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–10180 Filed 5–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0269] 

Agency Emergency Processing Under 

Office of Management and Budget 

Review; Implementation of Sections 

222, 223, and 224 of the Food and Drug 

Administration Amendments Act of 

2007 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for emergency processing under 

the Paperwork Reduction Act of 1995 

(the PRA). The proposed collection of 

information concerns the requirement 

established by the Food and Drug 

Administration Amendments Act of 

2007 (FDAAA), that device 

establishments must submit registration 

and listing information by electronic 

means using FDA Form 3673, unless the 

Secretary of Health and Human Services 

(the Secretary) grants them a waiver 

from the electronic submission 

requirement. 

DATES: Fax written comments on the 

collection of information by June 6, 

2008. 


sroberts on PROD1PC70 with NOTICES