Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Notices 59073 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0217] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Cosmetic Product 

Voluntary Reporting Program 

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 review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by November 

10, 2005. 

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. To ensure that comments on 

the information collection are received, 

OMB recommends that comments be 

faxed to the Office of Information and 

Regulatory Affairs, OMB, Attn: Fumie 

Yokota, Desk Officer for FDA, FAX: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Cosmetic Product Voluntary Reporting 

Program—21 CFR Part 720 (OMB 

Control Number 0910–0030)—Extension 

Under the Federal Food, Drug, and 

Cosmetic Act (the act), cosmetic 

products that are adulterated under 

section 601 of the act (21 U.S.C. 361), 

or misbranded under section 602 of the 

act (21 U.S.C. 362), cannot legally be 

distributed in interstate commerce. To 

assist FDA in carrying out its 

responsibility to regulate cosmetics, 

FDA requests under part 720 (21 CFR 

part 720), but does not require, 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 (§§ 720.3, 720.4, 

and 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, 

‘‘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 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 has developed an electronic 

submission system for filing Forms FDA 

2512, FDA 2512a, and FDA 2514 that 

will reduce the reporting burden for 

respondents and FDA. The system is 

currently undergoing additional beta 

testing and implementation is 

anticipated for fall 2005. 

In the Federal Register of June 13, 

2005 (70 FR 34142), FDA published a 

60-day notice requesting public 

comment on the proposed extension of 

an existing collection of information 

described by the regulations in part 720. 

FDA received two letters, one from a 

trade association and one from a 

cosmetic company, each containing one 

or more comments, in response to the 

proposed extension of existing 

collection of information for part 720. 

The trade association commended the 

agency for making the Cosmetic Product 

Voluntary Reporting Program less 

burdensome on the cosmetic industry 

by modernizing the program to take 

advantage of technological advances. 

The cosmetic company stated, however, 

that the requirement for both the 

ingredient name and a 9-digit 

identification number on Form FDA 

2512a is burdensome. 

FDA appreciates the trade 

association’s remarks as well its 

assistance in making the voluntary 

reporting system more efficient. As to 

the burdensomeness of the dual 

requirement expressed by the cosmetic 

company, FDA expects to have its new 

system for electronic submission of 

cosmetic ingredient information to the 

Cosmetic Product Voluntary Reporting 

Program, which is currently in the beta 

testing stage, implemented in fall 2005. 

FDA expects that the new system will 

greatly simplify the submission of 

cosmetic ingredient information to the 

program by, among other things, 

permitting either the identification 

number or ingredient name to be 

submitted (except for new ingredients). 

The cosmetic company also requested 

that FDA accept submission of a single 

Form FDA 2512 for groups of hair color 

preparations for which only the 

amounts of color additive ingredients 

are varied. FDA is not granting this 

request as it will be unnecessary once 

the agency implements its new 

electronic submission system. The 

agency’s new electronic submission 

system will facilitate new submissions 

by making frequently used ingredients 

accessible from a ‘‘favorites’’ list and by 

making ingredient formulations 

previously submitted on the paper 

forms accessible to users of the new 

system upon proof of ownership. 

The cosmetic company also requested 

that FDA modify the continuation footer 

in the paper version of Form FDA 

2512a. FDA does not believe the 

requested change is necessary because 

the agency expects that its new 

electronic submission system will 

greatly reduce the use of paper versions 

of Forms FDA 2512, FDA 2512a, and 

FDA 2514. 

The cosmetic company suggested that 

FDA revise the product categories in 

§ 720.4(c) to include new types of 

products. FDA is not making the 

suggested revision. The agency does not 

believe this revision is necessary 

because each category already provides 

a subcategory for ‘‘other preparations’’

that covers products that do not fit in 

the specified subcategories. 

Finally, the cosmetic company 

recommended that FDA’s new 

electronic submission system provide 

for direct transfer of information from 

company databases to FDA’s. FDA is not 

permitting this recommended direct 

transfer of information for security 

reasons. The agency has to limit the 

59074 Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Notices 

ways people can enter data into the 

electronic submission system to protect 

the database from corruption. 

FDA estimates the burden of the 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Form No. No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

720.1 through 720.4 (new 

submissions) 

FDA 2512 and 

FDA 2512a 

112 12.9 1,446 0 .5 723 

720.4 and 720.6 (amendments) FDA 2512 and 

FDA 2512a 

112 0.5 52 0 .33 17 

720.3 and 720.6 (notices 

of discontinuance) 

FDA 2514 112 1 4 0 .1 0 .4 

720.8 (requests for confidentiality) 1 1 1 1 .5 1 .5 

Total 742 

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

These estimates are based on FDA’s 

experience with the Cosmetic Product 

Voluntary Reporting Program. The 

estimated annual total hours burden is 

75 percent of the burden reported in 

2002 due to decreased submissions. 

However, the number of respondents 

doubled, and FDA attributes this to 

increased interest in the program. FDA 

expects the number of submissions to 

increase accordingly in the next 3 years. 

Dated: October 3, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20307 Filed 10–7–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0124] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Guidance for Industry: Notification of a 

Health Claim or Nutrient Content Claim 

Based on an Authoritative Statement 

of a Scientific Body 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Guidance for Industry: Notification of 

a Health Claim or Nutrient Content 

Claim Based on an Authoritative 

Statement of a Scientific Body’’ has 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 16, 2005 (70 FR 

35097), 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 0910–0374. The 

approval expires on September 30, 

2008. A copy of the supporting 

statement for this information collection 

is available on the Internet at http:// 

www.fda.gov/ohrms/dockets. 

Dated: October 3, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–20308 Filed 10–7–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0401] 

Draft Guidance for Industry and FDA 

Staff: Compliance With the Medical 

Device User Fee and Modernization 

Act of 2002, as amended—Prominent 

and Conspicuous Mark of 

Manufacturers on Single-Use Devices; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Compliance With Section 301 

of the Medical Device User Fee and 

Modernization Act of 2002, as 

amended—Prominent and Conspicuous 

Mark of Manufacturers on Single-Use 

Devices.’’ The Medical Device User Fee 

and Modernization Act of 2002 

(MDUFMA), as amended by the Medical 

Device User Fee Stabilization Act of 

2005 (MDUFSA), requires that FDA 

issue guidance within 180 days of 

enactment (August 1, 2005) identifying 

the circumstances in which the name, 

abbreviation, or symbol identifying the 

manufacturer of an original device is not 

‘‘prominent and conspicuous.’’

DATES: Submit written or electronic 

comments on this draft guidance so that 

they are received by close of business on 

November 10, 2005. FDA will not be 

able to consider comments received 

after that date in developing the final 

guidance. FDA may consider late 

comments at a future time if the