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number, the draft guidance includes 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
198 Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices 

INFORMATION section for electronic 

access to the draft guidance. 

Submit written comments on the draft 

guidance, including comments 

regarding proposed collection of 

information, to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to either http:// 

www.fda.gov/dockets/ecomments or 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Vasilios Frankos, Center for Food Safety 

and Applied Nutrition (HFS–810), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–2375. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance entitled ‘‘Guidance for 

Industry: Questions and Answers 

Regarding the Labeling of Dietary 

Supplements as Required by the Dietary 

Supplement and Nonprescription Drug 

Consumer Protection Act.’’ On 

December 22, 2006, the President signed 

into law the DSNDCPA (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 for dietary supplements 

under the DSNDCPA. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent FDA’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. 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 in this document. 

With respect to the following 

collection of information, FDA invites 

comment 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 on respondents, including 

through the use of automated collection 

techniques, when appropriate, and other 

forms of information technology. 

Title: Dietary Supplement Labeling 

Requirements and Recommendations 

under the Dietary Supplement and 

Nonprescription Drug Consumer 

Protection Act. 

Description of Respondents: 

Respondents to this collection of 

information are manufacturers, packers, 

and distributors of dietary supplements 

marketed in the United States. 

The draft guidance is intended to 

assist the dietary supplement industry 

in complying with the dietary 

supplement labeling requirements of 

section 403(y) of the act (21 U.S.C. 

343(y)), which was added by the 

DSNDCPA. 

Section 403(y) of the act requires the 

label of a dietary supplement being 

marketed in the United States to include 

a domestic address or domestic 

telephone number through which the 

responsible person may receive a report 

of a serious adverse event with such 

dietary supplement. If the label does not 

include the required domestic address 

or telephone number, the dietary 

supplement is misbranded. When the 

responsible person chooses to provide a 

domestic address (rather than a 

telephone 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 identified on the 

dietary supplement 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 telephone number 

for adverse event reporting, FDA 

concludes that the statute requires the 

telephone number on the product label 

to include the area code. Without the 

area code, the telephone 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 for dietary supplement 

labels to include a domestic address or 

a domestic telephone number, the draft 

guidance recommends that the label 

bear a clear, prominent statement 

informing consumers that the domestic 

address or telephone number is for 

reporting serious adverse events 

associated with use of the product. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Domestic address or telephone 

number labeling requirement 

(21 U.S.C. 343(y)) 1,460 15.4616 22,574 4 90,296 

FDA recommendation for label 

statement explaining purpose 

of domestic address or telephone number 1,460 15.4616 22,574 4 90,296 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices 199 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Total Burden Hours 180,592 

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

Using FDA’s Labeling Cost Model, 

FDA estimates that there are 22,574 

stockkeeping units (SKUs) for unique 

dietary supplement pills and liquids for 

which labels would have to bear the 

complete domestic address or domestic 

telephone number of the responsible 

person for that supplement. This 

estimate of the number of SKUs for 

dietary supplements is an underestimate 

of the total number of dietary 

supplements on the market because 

dietary supplements are marketed in a 

variety of forms other than pills and 

liquids. However, this is the most 

comprehensive estimate available to 

FDA. FDA requests comments on the 

total number of SKUs for dietary 

supplements that are marketed in the 

United States. 

In the economic impact analysis of 

the Dietary Supplement Good 

Manufacturing Practices final rule (the 

GMP final rule) FDA estimated that 

there were about 1,460 dietary 

supplement manufacturers, repackagers, re-labelers, and holders of 

dietary supplements (June 25, 2007; 72 

FR 34752 at 34920). Assuming the 

22,574 SKUs are split equally among the 

firms, then each firm would be 

responsible for updating about 15 SKUs. 

The estimate of the number of 

manufacturers, re-packagers, re-labelers, 

and holders of dietary supplements 

from the GMP final rule is FDA’s best 

estimate of the number of firms that are 

‘‘responsible persons’’ who must 

comply with the new labeling 

requirement added by the DSNDCPA; 

however, it is not a precise estimate 

because the number of dietary 

supplement establishments covered by 

the GMP final rule is likely to be larger 

than the number of ‘‘responsible 

persons,’’ where a ‘‘responsible person’’

is a dietary supplement manufacturer, 

packer, or distributor whose name is 

listed on the label of a dietary 

supplement associated with a serious 

adverse event (see section 761(b)(1) of 

the act (21 U.S.C. 379aa–1(b)(1)). Thus, 

FDA’s estimate for number of 

respondents in table 1 of this document 

may be over inclusive. FDA requests 

comments on the number of firms that 

would be subject to the labeling 

requirements of the DSNDCPA. 

FDA does not know how many of the 

22,574 dietary supplement SKUs would 

have to undergo a label change to 

include the complete domestic address 

or domestic telephone number of the 

responsible person as required by the 

DSNDCPA. Based on the agency’s 

experience with regulating dietary 

supplements, FDA believes that some 

dietary supplement labels (SKUs) 

already have the full domestic address 

or telephone number of the responsible 

person printed on the label and thus 

will not need to be redesigned to 

comply with section 403(y) of the act. 

The agency does not have any 

information on which to base a 

quantitative estimate of the number of 

labels that already meet the 

requirements of section 403(y) of the 

act, however. Therefore, FDA is 

assuming conservatively that all labels 

will need to be redesigned. 

Assuming further that redesigning a 

dietary supplement label to add a 

domestic address or telephone number 

requires one color change, and no 

analytical tests are performed on the 

new label, then FDA believes that 

designing the label change should not 

take longer than 4 hours per label. This 

time would be used to assess the current 

layout of each label and choose the best 

location for the domestic address or 

telephone number. Automated printing 

of the labels should only require a few 

seconds per label. 

In addition to changing their labels to 

meet the statutory requirement for a 

domestic address or a domestic 

telephone number, dietary supplement 

firms may also choose to adopt the draft 

guidance’s recommendation that the 

label bear a clear, prominent statement 

informing consumers that the domestic 

address or telephone number is for 

reporting serious adverse events 

associated with use of the product. In 

the absence of any information about 

how many firms are likely to add such 

an explanatory statement to their dietary 

supplement labels, FDA is assuming 

conservatively that the explanatory 

statement will be added to all dietary 

supplement labels. 

FDA estimates that the burden of 

including the recommended 

explanatory statement on the label will 

be similar to the burden of adding the 

full domestic address or telephone 

number to the dietary supplement label. 

We assume it will take 4 hours per label 

to assess the current layout of each label 

and choose the best location for the 

explanatory statement. Again we 

assume this label modification would 

require one color change and that no 

premarket testing of the label wording 

would be performed. FDA requests 

comments on how many dietary 

supplement firms and products would 

follow FDA’s recommendation to 

include such an explanatory statement 

on the product’s label. FDA also 

requests comments on the burden 

associated with placing this explanatory 

statement on the dietary supplement 

label. 

The likely overestimate of the total 

burden caused by FDA’s conservative 

assumption that all dietary supplement 

labels (SKUs) will be redesigned to add 

a domestic address or telephone number 

and to include an explanatory statement 

for consumers is offset to some degree 

by the underestimate of the number of 

SKUs in the marketplace resulting from 

FDA’s lack of information on the 

number of SKUs for dietary 

supplements that are sold in a nonliquid or non-pill form. FDA requests 

comments on the burden estimates 

presented in table 1 of this document. 

The agency is especially interested in 

comments that include information 

about: (1) The number of dietary 

supplements marketed in the United 

States in all forms and (2) the number 

or percentage of dietary supplements 

marketed in the United States that will 

not require a label change to comply 

with the requirement that dietary 

supplements bear a complete domestic 

address or telephone number. The 

agency would also welcome information 

on whether dietary supplement firms 

plan to add the recommended 

explanatory statement to their product 

labels. 

III. 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 


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

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. 

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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at http:// 

www.cfsan.fda.gov/guidance.html. 

Dated: December 26, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–6266 Filed 12–27–07; 3:08 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

will publish periodic summaries of 

proposed projects. To request more 

information on the proposed projects or 

to obtain a copy of the information 

collection plans, call the SAMHSA 

Reports Clearance Officer on (240) 276–

1243. 

Comments are invited on: (a) Whether 

the proposed collections of information 

are necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: Opioid Treatment 

Programs (OTPs) Mortality Reporting 

Form—NEW 

The Substance Abuse and Mental 

Health Services Administration 

(SAMHSA), Center for Substance Abuse 

Treatment (CSAT), has developed a 

voluntary reporting form for Opioid 

Treatment Programs (OTPs) to report 

mortality data on patients who at the 

time of death, were enrolled in the 

Programs that were certified to operate 

by SAMHSA. 

Methadone is a Schedule II controlled 

substance approved by the Food and 

Drug Administration for the treatment of 

opioid dependence and pain. Although 

it has proven safe and effective, it must 

be carefully administered and for that 

reason, treatment of opioid dependence 

with methadone is provided only 

through specialized and Federally 

regulated and accredited clinics, the 

OTPs. Buprenorphine, a Schedule III 

controlled ssubstance, is also used in 

the treatment of opioid addiction by 

OTPs and office-based physicians. 

In recent years, methadone has been 

associated with an increasing number of 

deaths around the country. 

Simultaneously, the use of methadone 

for pain has increased significantly over 

the last 5 to 10 years. While the Food 

and Drug Administration (FDA) 

maintains oversight of methadone for 

use in pain, SAMHSA provides 

oversight of methadone for use in opioid 

addiction treatment. Currently, there is 

no national database that tracks 

mortality among patients receiving 

methadone in OTPs and as a result, it 

is not clear whether and to what extent 

the increase in methadone-associated 

deaths may be related to treatment in 

OTPs. MedWatch, a voluntary reporting 

system maintained by FDA, provides 

information relevant to its role in its 

more general oversight of medication 

and device safety. A similar system is 

needed within SAMHSA to gather 

information directly relevant to the 

agency’s mission of overseeing and 

ensuring safe and effective treatment for 

patients with opioid dependence. 

In order to more accurately 

understand potential methadoneassociated deaths at the OTP level, it is 

necessary to examine all patient deaths, 

including those related to 

buprenorphine. Understanding the 

actual cause of death of patients 

enrolled in OTPs can be a challenging 

task for many reasons, including 

inconsistencies in methods of reporting 

causes of deaths across different 

localities and officials; patients’ use of 

other drugs, including illicit, over-thecounter, and prescription products; and 

other aspects of the patient’s physical 

and mental condition. The standardized 

terminology to be used for reporting in 

the proposed system will contribute to 

a more precise and relevant analysis of 

individual cases and higher-level 

trends. The data will be used by 

SAMHSA to increase understanding of 

the factors contributing to these deaths, 

identify preventable causes of deaths, 

and ultimately, take appropriate action 

to minimize risk and help improve the 

quality of care. Importantly, better data 

will enable the agency to more 

proactively manage the oversight of 

treatment. 

The information requested from OTPs 

should be readily available to any OTP 

that has met accreditation standards. 

The OTP should not find any need to 

otherwise analyze or synthesize new 

data in order to complete this form. 

ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR OPIOID TREATMENT PROGRAMS

Form 

Number of 

facilities 

(OTPs) 

Responses 

per facility 

Burden 

responses 

(hours) 

Annual 

burden 

(hours) 

SAMHSA OTP Mortality Report ....................................................................... 1,150 2 0.5 1,150 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 7–1044, One Choke Cherry Road, 

Rockville, MD 20857 and e-mail her a 

copy at summer.king@samhsa.hhs.gov. 

Written comments should be received 

within 60 days of this notice. 

Dated: December 31, 2007. 

Elaine Parry, 

Acting Director, Office of Program Services. 

[FR Doc. 07–6254 Filed 12–31–07; 8:45 am] 

BILLING CODE 4162–20–M 


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