196 Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices 

Dated: December 26, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–6268 Filed 12–27–07; 3:08 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D– 0496] 

Draft Guidance for Industry on 

Questions and Answers Regarding the 

Labeling of Nonprescription Human 

Drug Products Marketed Without an 

Approved Application as Required by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Questions and Answers Regarding the 

Labeling of Nonprescription Human 

Drug Products Marketed Without an 

Approved Application as Required by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act.’’ This draft guidance is 

intended to assist industry in complying 

with the labeling requirements for 

nonprescription (over-the-counter 

(OTC)) human drugs marketed without 

an approved application established by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act. Separate guidance, 

issued by the Center for Food Safety and 

Applied Nutrition on labeling 

requirements for dietary supplements, is 

announced elsewhere in this issue of 

the Federal Register. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comments on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance, including comments 

regarding proposed collection of 

information, by March 3, 2008. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, addressStreet5630 

Fishers Lane, rm. 1061, 

placeCityRockville, StateMD 

PostalCode20852. Submit electronic 

comments to http://www.fda.gov/ 

dockets/ecomments or http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Walter Ellenberg, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 5488, 

Silver Spring, MD 20993, 301–796–

2090. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance entitled ‘‘Questions and 

Answers Regarding the Labeling of 

Nonprescription Human Drug Products 

Marketed Without an Approved 

Application as Required by the Dietary 

Supplement and Nonprescription Drug 

Consumer Protection Act.’’ On 

December 22, 2006, the President signed 

into law the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act (Public Law 109–462, 

120 Stat. 3469). This law amends the 

Federal Food, Drug, and Cosmetic Act 

(the act) with respect to serious adverse 

event reporting for dietary supplements 

and nonprescription drugs marketed 

without an approved application. The 

draft guidance document contains 

questions and answers relating to the 

new labeling requirements under Public 

Law 109–462 for OTC drugs marketed 

without an approved application. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on this topic. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the requirement 

of the applicable statutes and 

regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that in January 2008, the 

FDA Web site is expected to transition 

to the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. After the transition 

date, electronic submissions will be 

accepted by FDA through the FDMS 

only. When the exact date of the 

transition to FDMS is known, FDA will 

publish a Federal Register notice 

announcing that date. 

III. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (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 

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 as follows. 

With respect to the following 

collection of information, FDA invites 

comment on the following: (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 on respondents, including 

through the use of automated collection 

techniques, when appropriate, and other 

forms of information technology. 

Title: Labeling Requirements and 

Recommendations under the Dietary 

Supplement and Nonprescription Drug 

Consumer Protection Act for 

Nonprescription Drug Products 

Marketed Without an Approved 

Application. 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices 197 

Description of Respondents: 

Respondents to this collection of 

information are manufacturers, packers, 

and distributors whose name (under 

section 502(b)(1) of the act) appears on 

the label of a nonprescription drug 

marketed in the United States. 

Burden Estimate: FDA is requesting 

public comment on the estimated onetime reporting burden from these 

respondents, as required by Public Law 

109–462 and described in the draft 

guidance. This guidance document 

discusses the labeling requirements of 

section 502(x) of the act (21 U.S.C. 

352(x)), which was added by Public Law 

109–462. 

Section 502(x) of the act requires the 

label of an OTC drug product marketed 

without an approved application in the 

United States to include a domestic 

address or domestic phone number 

through which the responsible person 

may receive a report of a serious adverse 

event associated with the product. If the 

label does not include the required 

domestic address or phone number, the 

drug product is misbranded. When the 

responsible person chooses to provide a 

domestic address (rather than a phone 

number) for adverse event reporting, 

FDA concludes that the statute requires 

the product label to bear a full U.S. 

mailing address that includes the street 

address or P.O. Box, city, state, and zip 

code of the responsible person (i.e., the 

manufacturer, packer, distributor, or 

retailer whose name appears on the 

label). This labeling requirement helps 

to ensure that any mailed adverse event 

report will reach the responsible person. 

Similarly, when the responsible person 

chooses to provide a domestic phone 

number for adverse event reporting, 

FDA concludes that the statute requires 

the phone number on the product label 

to include the area code. Without the 

area code, the phone number is 

incomplete and does not serve its 

intended purpose of enabling the 

consumer to contact the responsible 

person to report a serious adverse event. 

In addition to discussing the statutory 

requirement that labels include a 

domestic address or a domestic phone 

number, the draft guidance includes 

recommendations about the location of 

this information on the label and the 

recommendation that the label make 

clear the purpose of this information. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ONE-TIME REPORTING BURDEN1

No. of 

Respondents 

Frequency 

per Response 

Total 

Responses 

Hours Per 

Response Total Hours 

Domestic address or phone number labeling requirement (21 

U.S.C. 502(x)) and recommendation to clarify its purpose 200 500 100,000 4 400,000 

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

As indicated in Table 1 of this 

document, we estimate that 

approximately 200 manufacturers will 

revise approximately 100,000 labels 

total to add a full domestic address and 

a domestic telephone number, and 

should they choose to adopt the draft 

guidance’s recommendation, to add a 

statement identifying the purpose of the 

domestic address or telephone number. 

We specifically request comments on 

these estimates. FDA believes that 

designing the label change should not 

take longer than 4 hours per label. 

Automated printing of the labels should 

only require a few seconds per label. 

IV. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the draft guidance, 

including comments regarding proposed 

collection of information. Submit a 

single copy of electronic comments or 

two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments are 

to be identified with the docket number 

found in brackets in the heading of this 

document. The draft guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: December 26, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–6267 Filed 12–27–07; 3:08 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0491] 

Draft Guidance for Industry: Questions 

and Answers Regarding the Labeling 

of Dietary Supplements as Required by 

the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Questions and Answers Regarding the 

Labeling of Dietary Supplements as 

Required by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act.’’ This draft guidance is 

intended to assist the dietary 

supplement industry in complying with 

the labeling requirements prescribed for 

dietary supplement manufacturers, 

packers, and distributors by the Dietary 

Supplement and Nonprescription Drug 

Consumer Protection Act (the 

DSNDCPA). Separate guidance, issued 

by the Center for Drug Evaluation and 

Research on labeling requirements for 

nonprescription (over-the-counter) 

human drugs marketed without an 

approved application, is announced 

elsewhere in this issue of the Federal 

Register. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by March 3, 2008. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Nutritional Products, Labeling, 

and Dietary Supplements (HFS–800), 

Food and Drug Administration, 5100 

Paint Branch Pkwy., College Park, MD 

20740. Send one self-addressed 

adhesive label to assist the office in 

processing your request, or include a fax 

number to which the draft guidance 

may be sent. See the SUPPLEMENTARY


pwalker on PROD1PC71 with NOTICES