Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 45219 

TABLE 4.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Recordkeeping 

Total Annual 

Responses 

Hours per 

Response Total Hours2

203.30(a)(2) and 203.31(a)(2) 2,208 100 220,800 .50 110,400 

203.31(d)(1) and (d)(2) 2,208 1 2,208 40 88,320 

203.31(d)(4) 442 1 442 24 10,608 

203.31(e) 2,208 1 2,208 1 2,208 

203.34 90 1 90 40 3,600 

203.37(a) 50 4 200 6 1,200 

203.37(b) 50 40 2,000 6 12,000 

203.39(d) 65 1 65 1 65 

203.39(e) 3,221 1 3,221 .50 1,610 

203.39(f) 3,221 1 3,221 8 25,768 

203.39(g) 3,221 1 3,221 8 25,768 

203.50(a) 125 100 12,500 .17 2,125 

203.50(b) 125 100 12,500 .50 6,250 

203.50(d) 691 1 691 2 .0 1,382 

Total Recordkeeping Burden Hours 332,769 

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

2Estimates are not exact due to rounding. 

Dated: August 25, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21026 Filed 8–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0406] 

Agency Emergency Processing Under 

Office of Management and Budget 

Review; Tobacco Product 

Establishment Registration and 

Submission of Certain Health 

Information 

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 submission of 

tobacco product establishment 

registration and submission of certain 

health information, including ingredient 

listing and health related documents, as 

required by The Family Smoking 

Prevention and Tobacco Control Act 

(FSPTCA). 

DATES: Fax written comments on the 

collection of information by September 

16, 2009. FDA is requesting approval of 

this emergency processing by September 

16, 2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. All comments should be 

identified with the title, ‘‘Tobacco 

Product Establishment Registration and 

Submission of Certain Health 

Information.’’ Also include the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794, email: 

Jonnalynn.Capezzuto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA has 

requested emergency processing of this 

proposed collection of information 

under section 3507(j) of the PRA (44 

U.S.C. 3507(j)) and 5 CFR 1320.13. On 

June 22, 2009, the President signed 

FSPTCA into law (Public Law 111–31). 

Section 101 of FSPTCA amends the 

Federal Food, Drug, and Cosmetic Act 

(the act) by adding, among other things, 

new sections 904 (21 U.S.C. 394) and 

905 (21 U.S.C. 395). Section 905 

requires the annual registration of any 

‘‘establishment in any State engaged in 

the manufacture, preparation, 

compounding, or processing of a 

tobacco product or tobacco products.’’ 

Section 905 also requires this 

registration be completed by December 

31 of each year. To allow adequate time 

for establishment owners and operators 

to complete the registration process, and 

to match similar provisions applicable 

to other FDA regulated products, FDA 

plans to begin accepting establishment 

registrations on October 1, 2009. 

Section 904(a)(1) of the act requires 

each tobacco product manufacturer or 

importer, or agent thereof to submit a 

listing of all ingredients, including 

tobacco, substances, compounds, and 

additives that are, as of such date, added 

by the manufacturer to the tobacco, 

paper, filter, or other part of each 

tobacco product by brand and by 

quantity in each brand and subbrand. 

Section 904(a)(4) requires each tobacco 

mstockstill on DSKH9S0YB1PROD with NOTICES

45220 Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 

product manufacturer or importer, or 

agent thereof to submit all documents 

developed after enactment of the 

FSPTCA that relate to health, 

toxicological, behavioral, or physiologic 

effects of current or future tobacco 

products, their constituents (including 

smoke constituents), ingredients, 

components, and additives. This 

information must be submitted by 

December 22, 2009 (6 months after the 

date of enactment of FSPTCA). 

FDA plans to collect the information 

submission requirements of sections 

905, 904(a)(1), and 904(a)(4) of the act 

through a single electronic portal. In 

order to provide respondents with 

adequate time to prepare information for 

submission, FDA plans to launch the 

electronic portal for the collection of 

this information on October 1, 2009. If 

FDA were to use the normal PRA 

clearance procedures, the availability of 

the electronic portal and the submission 

of information by respondents could not 

begin with adequate time to meet the 

respective statutory deadlines. 

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. 

Title: Tobacco Product Establishment 

Registration and Submission of Certain 

Health Information 

Description of Respondents: 

Respondents to this collection of 

information are: (1) All persons who 

own or operate any establishment in any 

State engaged in the manufacture, 

preparation, compounding, or 

processing of a tobacco product or 

tobacco products; and (2) each tobacco 

product manufacturer or importer, or 

agents thereof. 

FSPTCA amends the act by creating a 

new category of regulated products, 

tobacco products. FSPTCA creates many 

new requirements for the tobacco 

industry. Section 101 of FSPTCA 

amends the act by adding, among other 

things, new sections 904 and 905. 

Section 905 requires the annual 

registration of any ‘‘establishment in 

any State engaged in the manufacture, 

preparation, compounding, or 

processing of a tobacco product or 

tobacco products.’’ The Secretary of 

Health and Human Services (the 

Secretary) has delegated to the 

Commissioner of Food and Drugs (the 

Commissioner) the responsibility for 

administering the act, including section 

905. 

Section 905 requires owners or 

operators of each establishment to 

register: 

1. Their name, 

2. Places of business, 

3. A list of all tobacco products which 

are manufactured by that person, 

4. A copy of all labeling and a 

reference to the authority for the 

marketing of any tobacco product 

subject to a tobacco product standard 

under section 907 of the act (21 U.S.C. 

397) or to premarket review under 

section 910 of the act (21 U.S.C. 399a), 

5. A copy of all consumer information 

and other labeling, 

6. A representative sampling of 

advertisements, 

7. Upon request made by the 

Secretary for good cause, a copy of all 

advertisements for a particular tobacco 

product, and 

8. Upon request made by the 

Secretary, if the registrant has 

determined that a tobacco product 

contained in the product list is not 

subject to a tobacco product standard 

established under section 907, a brief 

statement of the basis upon which the 

registrant made such determination. 

Section 904(a)(1) of the act requires 

each tobacco product manufacturer or 

importer, or agent thereof to submit a 

listing of all ingredients, including 

tobacco, substances, compounds, and 

additives that are, as of such date, added 

by the manufacturer to the tobacco, 

paper, filter, or other part of each 

tobacco product by brand and by 

quantity in each brand and subbrand. 

Section 904(a)(4) requires each tobacco 

product manufacturer or importer, or 

agent thereof, to submit all documents 

developed after enactment of the 

FSPTCA that relate to health, 

toxicological, behavioral, or physiologic 

effects of current or future tobacco 

products, their constituents (including 

smoke constituents), ingredients, 

components, and additives. 

The Secretary has delegated to the 

Commissioner the responsibility for 

administering the act, including section 

904. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Tobacco Product 

Establishment Registration 100,000 1 100,000 0.75 75,000 

Tobacco Product 

Ingredient Listing 100,000 1 100,000 0.75 75,000 

Documents Related to 

Health Information 10 1 10 1 10 

Total 150,010 

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

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 45221 

Dated: August 27, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21099 Filed 8–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0050] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Importer’s Entry Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Importer’s Entry Notice’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792, e-mail: 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 28, 2009 (74 FR 

25554), the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0046. The 

approval expires on August 31, 2012. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: August 26, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21097 Filed 8–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0209] (formerly 

Docket No. 2007D–0491) 

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 guidance document 

entitled ‘‘Questions and Answers 

Regarding the Labeling of Dietary 

Supplements as Required by the Dietary 

Supplement and Nonprescription Drug 

Consumer Protection Act.’’ The 

document provides guidance to the 

dietary supplement industry for 

complying with the labeling 

requirements prescribed for dietary 

supplement manufacturers, packers, and 

distributors by the Dietary Supplement 

and Nonprescription Drug Consumer 

Protection Act (DSNDCPA). Separate 

guidance on labeling requirements for 

nonprescription (over-the-counter) 

human drugs marketed without an 

approved application, issued by FDA’s 

Center for Drug Evaluation and 

Research, is announced elsewhere in 

this issue of the Federal Register. 

DATES: Submit written or electronic 

comments on the guidance at any time. 

ADDRESSES: Submit written comments 

on the guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written requests for single 

copies of the guidance to the Office of 

Nutrition, Labeling, and Dietary 

Supplements (HFS–800), Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration, 5100 

Paint Branch Pkwy., College Park, MD 

20750. Send two self-addressed 

adhesive labels to assist that office in 

processing your request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance. 

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 

On December 22, 2006, the President 

signed into law 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 law also 

amended the act to add section 403(y) 

(21 U.S.C. 343(y)), which requires the 

label of a dietary supplement marketed 

in the United States to include a 

domestic address or domestic telephone 

number through which the product’s 

manufacturer, packer, or distributor may 

receive a report of a serious adverse 

event associated with the dietary 

supplement. 

In the Federal Register of January 2, 

2008 (73 FR 197), FDA announced 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.’’ In addition to 

providing guidance for industry on how 

to comply with the labeling 

requirements in section 403(y) of the 

act, the draft guidance stated that FDA 

intended to begin enforcing the 

requirements of section 403(y) for 

dietary supplements labeled on or after 

January 1, 2009. Although interested 

parties can comment on any guidance at 

any time, to ensure that the agency 

would have the opportunity to consider 

comments on the draft guidance before 

it began work on the final version, FDA 

requested that interested parties submit 

comments by March 3, 2008. On 

December 11, 2008 (73 FR 75438), FDA 

announced the availability of a revised 

version of the draft guidance document 

to notify the dietary supplement 

industry and other members of the 

public that it intended to exercise 

enforcement discretion with regard to 

the labeling requirements of section 

403(y) of the act for an additional 1-year 

period (i.e., for dietary supplements 

labeled before January 1, 2010) because 

the agency was still in the process of 

reviewing the comments and finalizing 

the guidance. The agency has now 

completed its review and evaluation of 

the comments received and has 

modified the guidance where 

appropriate. 

The guidance contains questions and 

answers relating to the labeling 

requirements in section 403(y) of the act 

and provides guidance to industry on 

the following topics: (1) The meaning of 

‘‘domestic address’’ for purposes of the 

mstockstill on DSKH9S0YB1PROD with NOTICES