26406 Federal Register / Vol. 74, No. 104 / Tuesday, June 2, 2009 / Notices 

Dated: May 26, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–12746 Filed 6–1–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0221] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Labeling; 

Notification Procedures for Statements 

on Dietary Supplements 

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 information collection provisions of 

the regulation requiring manufacturers, 

packers, and distributors of dietary 

supplements to notify FDA that they are 

marketing a dietary supplement product 

that bears on its label or in its labeling 

a statement provided for in the Federal 

Food, Drug, and Cosmetic Act (the act). 

DATES: Submit written or electronic 

comments on the collection of 

information by August 3, 2009. 

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 Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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. 

Food Labeling; Notification Procedures 

for Statements on Dietary 

Supplements—21 CFR 101.93 (OMB 

Control Number 0910–0331)—Extension 

Section 403(r)(6) of the act (21 U.S.C. 

343(r)(6)) requires that the agency be 

notified by manufacturers, packers, and 

distributors of dietary supplements that 

they are marketing a dietary supplement 

product that bears on its label or in its 

labeling a statement provided for in 

section 403(r)(6). Section 403(r)(6) of the 

act requires that the agency be notified, 

with a submission about such 

statements, no later than 30 days after 

the first marketing of the dietary 

supplement. Information that is 

required in the submission includes the 

following items: (1) The name and 

address of the manufacturer, packer, or 

distributor of the dietary supplement 

product; (2) the text of the statement 

that is being made; (3) the name of the 

dietary ingredient or supplement that is 

the subject of the statement; (4) the 

name of the dietary supplement 

(including the brand name); and (5) a 

signature of a responsible individual 

who can certify the accuracy of the 

information presented, and who must 

certify that the information contained in 

the notice is complete and accurate, and 

that the notifying firm has 

substantiation that the statement is 

truthful and not misleading. 

The agency established § 101.93 (21 

CFR 101.93) as the procedural 

regulation for this program. Section 

101.93 provides details of the 

procedures associated with the 

submission and identifies the 

information that must be included in 

order to meet the requirements of 

section 403 of the act. 

Description of Respondents: 

Respondents to this collection of 

information include manufacturers, 

packers, or distributors of dietary 

supplements that bear section 403(r)(6) 

of the act statements on their labels or 

labeling. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

101.93 2,200 1 2,200 0.75 1,650 

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

The agency believes that there will be 

minimal burden on the industry to 

generate information to meet the 

requirements of section 403 of the act in 

submitting information regarding 

section 403(r)(6) statements on labels or 

in labeling of dietary supplements. The 

agency is requesting only information 

that is immediately available to the 

Federal Register / Vol. 74, No. 104 / Tuesday, June 2, 2009 / Notices 26407 

manufacturer, packer, or distributor of 

the dietary supplement that bears such 

a statement on its label or in its labeling. 

FDA estimates that, each year, 

approximately 2,200 firms will submit 

the information required by section 403 

of the act. We estimate that a firm will 

require 0.75 hours to gather the 

information needed and prepare a 

communication to FDA, for a total of 

1,650 hours (2,200 x 0.75). This estimate 

is based on the average number of 

notification submissions received by the 

agency in the preceding 2 years. 

Dated: May 26, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–12797 Filed 6–1–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0232] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Interstate Shellfish 

Dealers Certificate 

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 information collection provisions of 

the Interstate Shellfish Dealers 

Certificate. 

DATES: Submit written or electronic 

comments on the collection of 

information by August 3, 2009. 

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 Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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. 

Interstate Shellfish Dealers Certificate 

(OMB Control Number 0910–0021)— 

Extension 

Under 42 U.S.C. 243, FDA is required 

to cooperate with and aid State and 

local authorities in the enforcement of 

their health regulations and is 

authorized to assist States in the 

prevention and suppression of 

communicable diseases. Under this 

authority, FDA participates with State 

regulatory agencies, some foreign 

nations, and the molluscan shellfish 

industry in the National Shellfish 

Sanitation Program (NSSP). 

NSSP is a voluntary, cooperative 

program to promote the safety of 

molluscan shellfish by providing for the 

classification and patrol of shellfish 

growing waters and for the inspection 

and certification of shellfish processors. 

Each participating State and foreign 

nation monitors its molluscan shellfish 

processors and issues certificates for 

those that meet the State or foreign 

shellfish control authority’s criteria. 

Each participating State and nation 

provides a certificate of its certified 

shellfish processors to FDA on Form 

FDA 3038, ‘‘Interstate Shellfish Dealer’s 

Certificate.’’ FDA uses this information 

to publish the ‘‘Interstate Certified 

Shellfish Shippers List,’’ a monthly 

comprehensive listing of all molluscan 

shellfish processors certified under the 

cooperative program. If FDA did not 

collect the information necessary to 

compile this list, participating States 

would not be able to identify and keep 

out shellfish processed by uncertified 

processors in other States and foreign 

nations. Consequently, NSSP would not 

be able to control the distribution of 

uncertified and possibly unsafe shellfish 

in interstate commerce, and its 

effectiveness would be nullified. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity FDA Form No. No. of Respondents Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Submission of 

Interstate 

Shellfish 

Dealer’s 

Certificate 3,038 40 57 2,280 0.10 228 

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