Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cosmetic Product Voluntary Reporting Program, 59073-59074 [05-20307]

Download as PDF Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Notices 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, VerDate Aug<31>2005 16:40 Oct 07, 2005 Jkt 208001 ‘‘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. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 59073 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 E:\FR\FM\11OCN1.SGM 11OCN1 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 No. of Respondents Form No. Annual Frequency per Response Total Annual Responses Hours per Response 720.1 through 720.4 (new submissions) FDA 2512 and FDA 2512a 112 12.9 1,446 720.4 and 720.6 (amendments) FDA 2512 and FDA 2512a 112 0.5 720.3 and 720.6 (notices of discontinuance) FDA 2514 112 1 720.8 (requests for confidentiality) Total Hours 0.5 723 52 0.33 17 1 4 0.1 0.4 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: Management and Budget (OMB) under the Paperwork Reduction Act of 1995. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: Food and Drug Administration Peggy Robbins, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1223. 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 https:// www.fda.gov/ohrms/dockets. SUPPLEMENTARY INFORMATION: 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 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 VerDate Aug<31>2005 16:40 Oct 07, 2005 Jkt 208001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 [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 E:\FR\FM\11OCN1.SGM 11OCN1

Agencies

[Federal Register Volume 70, Number 195 (Tuesday, October 11, 2005)]
[Notices]
[Pages 59073-59074]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20307]



[[Page 59073]]

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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 (Sec. Sec.  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 
(Sec. Sec.  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'' (Sec. Sec.  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 Sec.  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 Sec.  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

[[Page 59074]]

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 Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          No. of       Annual Frequency     Total Annual      Hours per
           21 CFR Section                       Form No.               Respondents       per Response        Responses        Response      Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
720.1 through 720.4 (new             FDA 2512 and FDA 2512a                      112                12.9            1,446            0.5           723
 submissions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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          FDA 2514                                    112                   1                4            0.1             0.4
 discontinuance)
--------------------------------------------------------------------------------------------------------------------------------------------------------
720.8 (requests for                  ..............................                1                   1                1            1.5             1.5
 confidentiality)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                              742
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There 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
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