Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 78257 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Public Health 

Service Act section 

Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Hours per 

response Total hours 

1701(a)(4) ............................................................................ 308 3 924 0.17 157 

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

Based on the history of the PHN 

program, it is estimated that an average 

of three collections will be conducted a 

year. The total burden of response time 

is estimated at 10 minutes per survey. 

This was derived by CDRH staff 

completing the survey and through 

discussions with the contacts in trade 

organizations. 

Dated: December 8, 2010. 

Leslie Kux, 

Acting Assistant, Commissioner for Policy. 

[FR Doc. 2010–31387 Filed 12–14–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0623] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Voluntary 

Cosmetic Registration Program 

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 Agency’s Voluntary Cosmetic 

Registration Program (VCRP). 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 14, 2011. 

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: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850. 301–796– 

3793. 

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. 

Voluntary Cosmetic Registration 

Program—21 CFR Parts 710 and 720 

(OMB Control Number 0910–0027)— 

Revision 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) provides FDA with 

the authority to regulate cosmetic 

products in the United States. Cosmetic 

products that are adulterated under 

section 601 of the FD&C Act (21 U.S.C. 

361) or misbranded under section 602 of 

the FD&C Act (21 U.S.C. 362) may not 

be distributed in interstate commerce. 

To assist FDA in carrying out its 

responsibility to regulate cosmetics, the 

Agency has developed the VCRP. 

In 21 CFR part 710, FDA requests that 

establishments that manufacture or 

package cosmetic products register with 

the Agency on Form FDA 2511 entitled 

‘‘Registration of Cosmetic Product 

Establishment.’’ The term ‘‘Form FDA 

2511’’ refers to both the paper and 

electronic versions of the form. The 

electronic version of Form FDA 2511 is 

available on FDA’s VCRP Web site at 

http://www.fda.gov/Cosmetics/

GuidanceComplianceRegulatory

Information/VoluntaryCosmetics

RegistrationProgramVCRP/Online

Registration/default.htm. FDA’s online 

registration system, intended to make it 

easier to participate in the VCRP, was 

made available industrywide on 

December 1, 2005. The Agency strongly 

encourages electronic registration of 

Form FDA 2511 because it is faster and 

more convenient. A registering facility 

will receive confirmation of electronic 

registration, including a registration 

number, by e-mail, usually within 7 

business days. The online system also 

allows for amendments to past 

submissions. 

Because registration of cosmetic 

product establishments is not 

mandatory, voluntary registration 

provides FDA with the best information 

available about the locations, business 

trade names, and types of activity 

(manufacturing or packaging) of 

cosmetic product establishments. FDA 

places the registration information in a 

computer database and uses the 

information to generate mailing lists for 

distributing regulatory information and 

for inviting firms to participate in 

workshops on topics in which they may 

be interested. FDA also uses the 


hsrobinson on DSK69SOYB1PROD with NOTICES
78258 Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 

information for estimating the size of 

the cosmetic industry and for 

conducting onsite establishment 

inspections. Registration is permanent, 

although FDA requests that respondents 

submit an amended Form FDA 2511 if 

any of the originally submitted 

information changes. 

In part 720 (21 CFR part 720), FDA 

requests that firms that manufacture, 

pack, or distribute cosmetics file with 

the Agency an ingredient statement for 

each of their products. Ingredient 

statements for new submissions 

(§§ 720.1 through 720.4) are reported on 

Form FDA 2512, ‘‘Cosmetic Product 

Ingredient Statement,’’ and on Form 

FDA 2512a, a continuation form. 

Amendments to product formulations 

(§ 720.6) also are reported on Forms 

FDA 2512 and FDA 2512a. When a firm 

discontinues the commercial 

distribution of a cosmetic, FDA requests 

that the firm file Form FDA 2514, 

‘‘Notice of Discontinuance of 

Commercial Distribution of Cosmetic 

Product Formulation’’ (§§ 720.3 and 

720.6). If any of the information 

submitted on or with these forms is 

confidential, the firm may submit a 

request for confidentiality under 

§ 720.8. 

FDA’s online filing system is available 

on FDA’s VCRP Web site at http://wcms.

fda.gov/FDAgov/Cosmetics/Guidance

ComplianceRegulatoryInformation/

VoluntaryCosmeticsRegistration

ProgramVCRP/OnlineRegistration/

default.htm. The online filing system 

contains the electronic versions of 

Forms FDA 2512, 2512a, and 2514, 

which are collectively found within the 

electronic version of Form FDA 2512. 

The Agency strongly encourages 

electronic filing of Form FDA 2512 

because it is faster and more convenient. 

A filer will receive confirmation of 

electronic filing by e-mail. 

FDA places cosmetic product filing 

information in a computer database and 

uses the information for evaluation of 

cosmetic products currently on the 

market. Because filing of cosmetic 

product formulations is not mandatory, 

voluntary filings provide FDA with the 

best information available about 

cosmetic product ingredients and their 

frequency of use, businesses engaged in 

the manufacture and distribution of 

cosmetics, and approximate rates of 

product discontinuance and formula 

modifications. The information assists 

FDA scientists in evaluating reports of 

alleged injuries and adverse reactions 

from the use of cosmetics. The 

information also is used in defining and 

planning analytical and toxicological 

studies pertaining to cosmetics. 

Information from the database is 

releasable to the public under FDA 

compliance with the Freedom of 

Information Act. FDA shares 

nonconfidential information from its 

files on cosmetics with consumers, 

medical professionals, and industry. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section or part Form No. Number of 

respondents 

Annual 

frequency per 

response 

Total 

annual 

responses 

Hours per 

response 

Total 

hours 

Part 710 (registrations) ...................... FDA 2511 2 .......... 135 1 135 0 .2 27 

720.1 through 720.4 (new submissions).FDA 2512 3 .......... 141 31 4,371 0 .33 1,442 

720.6 (amendments) .......................... FDA 2512 ............ 109 7 763 0 .17 130 

720.6 (notices of discontinuance) ...... FDA 2512 ............ 55 41 2,255 0 .1 226 

720.8 (requests for confidentiality) .... .............................. 1 1 1 2 .0 2 .0 

Total ............................................ .............................. ........................ ........................ ........................ ........................ 1,827 

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

2The term ‘‘Form FDA 2511’’ refers to both the paper Forms FDA 2511 and electronic Form FDA 2511 in the electronic system known as the 

Voluntary Cosmetic Registration Program, which is available at http://wcms.fda.gov/FDAgov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/OnlineRegistration/default.htm. 3The term ‘‘Form FDA 2512’’ refers to the paper Forms FDA 2512, 2512a, and 2514 and electronic Form FDA 2512 in the electronic system 

known as the Voluntary Cosmetic Registration Program, which is available at http://wcms.fda.gov/FDAgov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/OnlineRegistration/default.htm. 

FDA bases its estimate of the number 

of responses on submissions received 

from fiscal years 2005 to 2007. FDA 

bases its estimate of the hours per 

response upon information from 

cosmetic industry personnel and FDA 

experience entering data submitted on 

paper Forms 2511, 2512, 2512a, and 

2514. FDA estimates that, annually, 135 

establishments that manufacture or 

package cosmetic products will each 

submit 1 registration on Form FDA 

2511, for a total of 135 annual 

responses. Each submission is estimated 

to take 0.2 hour per response for a total 

of 27 hours. FDA estimates that, 

annually, 141 firms that manufacture, 

pack, or distribute cosmetics will file 31 

ingredient statements for new 

submissions on Forms FDA 2512 and 

FDA 2512a, for a total of 4,371 annual 

responses. Each submission is estimated 

to take 0.33 hour per response for a total 

of 1,442.43 hours, rounded to 1,442. 

FDA estimates that, annually, 109 firms 

that manufacture, pack, or distribute 

cosmetics will file 7 amendments to 

product formulations on Forms FDA 

2512 and FDA 2512a, for a total of 763 

annual responses. Each submission is 

estimated to take 0.17 hour per response 

for a total of 129.71 hours, rounded to 

130. FDA estimates that, annually, 55 

firms that manufacture, pack, or 

distribute cosmetics will file 41 notices 

of discontinuance on Form FDA 2514, 

for a total of 2,255 annual responses. 

Each submission is estimated to take 0.1 

hour per response for a total of 225.50 

hours, rounded to 226. FDA estimates 

that, annually, one firm will file one 

request for confidentiality. Each such 

request is estimated to take 2 hours to 

prepare for a total of 2.0 hours. Thus, 

the total estimated hour burden for this 

information collection is 1,827 hours. 

This is a revision request in which the 

burden hours for the information 

collection request (ICR) under OMB 

control number 0910–0030, ‘‘Cosmetic 

Product Voluntary Reporting Program’’ 

are being consolidated under the ICR 

assigned OMB control number 0910– 

0027, ‘‘Voluntary Registration of 

Cosmetic Product Establishments,’’ 

which expires February 28, 2011. The 

revised ICR for 0910–0027 has been 

renamed ‘‘Voluntary Cosmetic 

Registration Program.’’ Upon approval of 

this revision request, the ICR for 0910– 

0030 will be discontinued. 


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 78259 

Dated: December 9, 2010. 

Leslie Kux, 

Acting Assistant, Commissioner for Policy. 

[FR Doc. 2010–31386 Filed 12–14–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0616] 

Draft Guidance for Industry on 

Codevelopment of Two or More 

Unmarketed Investigational Drugs for 

Use in Combination; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Codevelopment of 

Two or More Unmarketed 

Investigational Drugs for Use in 

Combination.’’ This guidance is 

intended to assist sponsors in the 

codevelopment of two or more novel 

(not previously marketed) drugs to be 

used in combination to treat a disease or 

condition. This guidance provides 

recommendations and advice on how to 

address certain scientific and regulatory 

issues that will arise during 

codevelopment. The guidance is not 

intended to apply to development of 

fixed-dose combinations of already 

marketed drugs or to development of a 

single new investigational drug to be 

used in combination with an approved 

drug or drugs. The guidance is also not 

intended to apply to vaccines, gene or 

cellular therapies, blood products, or 

medical devices. 

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 

either electronic or written comments 

on the draft guidance by February 14, 

2011. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Colleen Locicero, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm 4216, 

Silver Spring, MD 20993–0002, 301– 

796–1114. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Codevelopment of Two or More 

Unmarketed Investigational Drugs for 

Use in Combination.’’ The guidance is 

intended to assist sponsors interested in 

developing two or more novel (not 

previously marketed) drugs to be used 

in combination. Recent scientific 

advances have increased our 

understanding of the pathophysiological 

processes that underlie many complex 

diseases, such as cancer, cardiovascular 

disease, and infectious diseases. This 

increased understanding has provided 

further impetus for new therapeutic 

approaches that rely primarily or 

exclusively on combinations of drugs 

directed at multiple therapeutic targets 

to improve treatment response and 

minimize development of resistance. In 

settings in which combination therapy 

provides significant therapeutic 

advantages, there is growing interest in 

the development of combinations of 

investigational drugs not previously 

developed for any purpose. 

Because the existing developmental 

and regulatory paradigm focuses 

primarily on assessment of the 

effectiveness and safety of a single new 

investigational drug acting alone, or in 

combination with an approved drug, 

FDA believes guidance is needed to 

assist sponsors in the codevelopment of 

two or more unmarketed drugs. This 

guidance is intended to describe a highlevel, generally applicable approach to 

codevelopment of two or more 

unmarketed drugs. It describes the 

criteria for determining when 

codevelopment is an appropriate option, 

makes recommendations about 

nonclinical and clinical development 

strategies, and addresses certain 

regulatory process issues. The guidance 

does not apply to vaccines, gene or 

cellular therapies, or blood products. 

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 companion diagnostic devices. 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 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either http: 

//www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: December 9, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31426 Filed 12–14–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0618] 

Statement of Organization, Functions 

and Delegations of Authority 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has reorganized 

its Center for Tobacco Products (CTP) by 

establishing two new offices: Office of 

Health Communication and Education 

and the Office of Compliance and 

Enforcement. In addition, CTP has made 

improvements to the current offices’ 

functional statements. This 

organizational change is intended to fill 

the gaps in the current CTP structure 

and clarify major responsibilities 

designed for long-term success in 

administering the Family Smoking 

Prevention and Tobacco Control Act. 


hsrobinson on DSK69SOYB1PROD with NOTICES