Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Product Voluntary Reporting Program, 34142-34144 [05-11641]

Download as PDF 34142 Federal Register / Vol. 70, No. 112 / Monday, June 13, 2005 / Notices Approved but Unfunded Applications Applications that are approved but unfunded may be held over for funding in the next funding cycle, pending the availability of funds, for a period not to exceed one year. 3. Anticipated Announcement and Award Dates Applications will be reviewed during the Summer 2005. Grant awards will have a start date no later than September 30, 2005. VI. Award Administration Information 1. Award Notices The successful applicants will be notified through the issuance of a Financial Assistance Award document which sets forth the amount of funds granted, the terms and conditions of the grant, the effective date of the grant, the budget period for which initial support will be given, the non-Federal share to be provided, and the total project period for which support is contemplated. The Financial Assistance Award will be signed by the Grants Officer and transmitted via postal mail. Organizations whose applications will not be funded will be notified in writing. 2. Administrative and National Policy Requirements Grantees are subject to the requirements in 45 CFR part 74 (nongovernmental) or 45 CFR part 92 (governmental). Direct Federal grants, sub-award funds, or contracts under this program shall not be used to support inherently religious activities such as religious instruction, worship, or proselytization. Therefore, organizations must take steps to separate, in time or location, their inherently religious activities from the services funded under this program. Regulations pertaining to the prohibition of Federal funds for inherently religious activities can be found on the HHS Web site at http:// www.os.dhhs.gov/fbci/waisgate21.pdf. VII. Agency Contacts Program Office Contact: Pat Campiglia, Children’s Bureau, 330 C Street, SW., Washington, DC 20447, Phone: (202) 205–8060, e-mail: pcampiglia@acf.hhs.gov. Grants Management Office Contact: Peter Thompson, Grants Officer, Administration for Children and Families, Children’s Bureau, 330 C Street, SW. Room 2070, Washington, DC 20447, Phone: (202) 401–4608, e-mail: pathompson@acf.hhs.gov. VIII. Other Information Additional information about this program and its purpose can be located on the following Web sites: http:// www.acf.hhs.gov/programs/cb/. For general information regarding this announcement please contact: ACYF Operations Center, c/o The Dixon Group, Inc. Attn: Children’s Bureau, 118 Q St., NE., Washington, DC 20002–2132, Telephone: 866–796–1591. Notice: Beginning with FY 2005, the Administration for Children and Families (ACF) will no longer publish grant announcements in the Federal Register. Beginning October 1, 2005, applicants will be able to find a synopsis of all ACF grant opportunities and apply electronically for opportunities via: http:// www.Grants.gov. Applicants will also be able to find the complete text of http://www.acf.hhs.gov/grants/ index.html. Please reference Section IV.3 for details about acknowledgement of received applications. Dated: June 2, 2005. Joan E. Ohl, Commissioner, Administration on Children, Youth, and Families. [FR Doc. 05–11592 Filed 6–10–05; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families 3. Reporting Requirements Correction Program Progress Reports: SemiAnnually. Financial Reports: Semi-Annually. Grantees will be required to submit program progress and financial reports (SF 269) throughout the project period. Program progress and financial reports are due 30 days after the reporting period. In addition, final programmatic and financial reports are due 90 days after the close of the project period. The Office of Community Services Program Announcement HHS–2005– ACF–OCS–EN–0018 was published in the Federal Register on June 6, 2005. On page 32794 of this announcement, the due date for applications is July 21, 2005. On page 32800 of this announcement, the due date for applications is August 5, 2005. The correct due date for applications for this announcement is July 21, 2005. VerDate jul<14>2003 16:45 Jun 10, 2005 Jkt 205001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 Dated: June 6, 2005. Josephine B. Robinson, Director, Office of Community Services. [FR Doc. 05–11591 Filed 6–10–05; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0217] Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Product Voluntary Reporting 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 Cosmetic Product Voluntary Reporting Program. DATES: Submit written or electronic comments on the collection of information by August 12, 2005. ADDRESSES: Submit electronic comments on the collection of information to: http://www.fda.gov/ dockets/ecomments. 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: Peggy Robbins, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–1223. 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 E:\FR\FM\13JNN1.SGM 13JNN1 34143 Federal Register / Vol. 70, No. 112 / Monday, June 13, 2005 / Notices 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. 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 summer 2005. FDA estimates the annual burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Annual Frequency per Response No. of Respondents Total Annual Responses Hours per Response 21 CFR Section Form No. 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) 0.5 723 52 0.33 17 1 4 0.1 0.4 1 1 1.5 1.5 Total 1 There Total Hours 742 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate jul<14>2003 16:45 Jun 10, 2005 Jkt 205001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\13JNN1.SGM 13JNN1 34144 Federal Register / Vol. 70, No. 112 / Monday, June 13, 2005 / Notices Services, 1 Choke Cherry Road, Room 8– 1002, Rockville, MD 20857, Telephone: (240) 276–2254, Fax: (240) 276–2252, E-mail: carol.watkin2@samhsa.gov. These estimates are based on FDA’s experience with the Cosmetic Product Voluntary Reporting Program. The estimated annual total hour 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. BILLING CODE 4162–20–P Dated: June 6, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–11641 Filed 6–10–05; 8:45 am] DEPARTMENT OF HOMELAND SECURITY BILLING CODE 4160–01–S Dated: June 6, 2005. Toian Vaughn, Committee Management Officer, Substance Abuse and Mental Health Services Administration. [FR Doc. 05–11618 Filed 6–10–05; 8:45 am] Procedural Coast Guard [USCG–2005–21399] DEPARTMENT OF HEALTH AND HUMAN SERVICES Towing Safety Advisory Committee Coast Guard, DHS. Notice of meetings. Substance Abuse and Mental Health Services Administration AGENCY: Office for Women’s Services; Notice of a Meeting SUMMARY: The Towing Vessel Inspection Working Group of the Towing Safety Advisory Committee (TSAC) will meet to discuss matters relating to those specific issues of towing safety. The meetings will be open to the public. DATES: The Towing Vessel Inspection Working Group will meet on Wednesday, June 22, 2005 from 1:30 p.m. to 4:30 p.m. and on Thursday, June 23, 2005 from 8:30 a.m. to 2 p.m. The meetings may close early if all business is finished. Written material and requests to make oral presentations should reach the Coast Guard on or before June 15, 2005. Requests to have a copy of your material distributed to each member of the Working Group should reach the Coast Guard on or before June 15, 2005. ADDRESSES: The Working Group will meet at George Mason University, Arlington Campus, 3301 Fairfax Drive, Arlington, VA 22201. Please bring a government-issued ID with photo (e.g., driver’s license). Send written material and requests to make oral presentations to Mr. Gerald Miante, Commandant (GMSO–1), U.S. Coast Guard Headquarters, 2100 Second Street SW., Washington, DC 20593–0001. This notice and related documents are available on the Internet at http:// dms.dot.gov under the docket number USCG–2004–21399. FOR FURTHER INFORMATION CONTACT: Mr. Gerald Miante, Assistant Executive Director of TSAC, telephone 202–267– 0214, fax 202–267–4570, or e-mail gmiante@comdt.uscg.mil. Pursuant to Pub. L. 92–463, notice is hereby given of a Substance Abuse and Mental Health Services Administration’s (SAMHSA) Advisory Committee for Women’s Services teleconference meeting on June 21, 2005. The meeting will be open and include discussions on SAMHSA’s women’s issues as they relate to the Agency’s priority matrix. The meeting will also include discussions on the Agency’s current administrative, legislative and policy developments. Attendance by the public will be limited to space available. Public comments are welcome. Please communicate with the individual listed as contact below to make arrangements to comment or to request special accommodations for persons with disabilities. Substantive program information and a roster of Committee members may be obtained by accessing the SAMHSA Advisory Council’s Web site (http:// www.samhsa.gov) as soon as possible after the meeting or by communicating with the contact whose name and telephone number are listed below. The transcript for the session will also be available on the SAMHSA Advisory Council Web site as soon as possible after the meeting. Committee Name: Substance Abuse and Mental Health Services Administration Advisory Committee for Women’s Services. Meeting Date: June 21, 2005, 1 p.m.–3 p.m. Place: 1 Choke Cherry Road, Conference Room 8–1082, Rockville, MD 20857. Type: Open. Contact: Carol Watkins, Executive Secretary, Advisory Committee for Women’s VerDate jul<14>2003 16:45 Jun 10, 2005 Jkt 205001 ACTION: Notice of these meetings is given under the Federal Advisory Committee Act, 5 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00063 Fmt 4703 U.S.C. App. 2 (Pub. L. 92–463, 86 Stat. 770, as amended). Agenda of Working Group Meetings: The agenda for the Towing Vessel Inspection Working Group tentatively includes the following items: (1) What proposed equipment standards should be included in a subchapter devoted to the inspection for certification of towing vessels; and (2) Which standards found in existing regulations, if any, are suitable for inclusion in a subchapter devoted to the inspection for certification of towing vessels? Sfmt 4703 The meetings are open to the public. Please note that the meetings may close early if all business is finished. At the Chair’s discretion, members of the public may make oral presentations during the meeting. If you would like to make an oral presentation at the meeting, please notify the Assistant Executive Director (as provided above in for further information contact) no later than June 15, 2005. Written material for distribution at the meeting should reach the Coast Guard no later than June 15, 2005. Information on Services for Individuals With Disabilities For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact Mr. Miante at the number listed in FOR FURTHER INFORMATION CONTACT as soon as possible. Dated: June 3, 2005. Raymond Petow, Acting Director of Standards, Marine Safety, Security and Environmental Protection. [FR Doc. 05–11588 Filed 6–10–05; 8:45 am] BILLING CODE 4910–15–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service North Mississippi National Wildlife Refuge Complex Fish and Wildlife Service, Department of the Interior. ACTION: Notice of Availability of the Draft Comprehensive Conservation Plan and Environmental Assessment for the North Mississippi National Wildlife Refuge Complex, which consists of three national wildlife refuges—Coldwater River, Dahomey, and Tallahatchie, as well as a number of Farmers Home Administration tracts in the northern section of the Mississippi Delta. AGENCY: E:\FR\FM\13JNN1.SGM 13JNN1

Agencies

[Federal Register Volume 70, Number 112 (Monday, June 13, 2005)]
[Notices]
[Pages 34142-34144]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11641]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0217]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Cosmetic Product Voluntary Reporting 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 Cosmetic Product Voluntary Reporting Program.

DATES: Submit written or electronic comments on the collection of 
information by August 12, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

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

[[Page 34143]]

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.

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 summer 2005.
    FDA estimates the annual burden of this collection of information 
as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
  21 CFR                                       Annual Frequency     Total Annual     Hours per
  Section    Form No.    No. of Respondents      per Response        Responses        Response      Total Hours
----------------------------------------------------------------------------------------------------------------
720.1       FDA 2512                     112               12.9             1,446           0.5              723
 through     and FDA
 720.4       2512a
 (new
 submissio
 ns)
----------------------------------------------------------------------------------------------------------------
720.4 and   FDA 2512                     112                0.5                52           0.33              17
 720.6       and FDA
 (amendmen   2512a
 ts)
----------------------------------------------------------------------------------------------------------------
720.3 and   FDA 2514                     112                1                   4           0.1              0.4
 720.6
 (notices
 of
 discontin
 uance)
----------------------------------------------------------------------------------------------------------------
720.8       .........                      1                1                   1           1.5              1.5
 (requests
 for
 confident
 iality)
----------------------------------------------------------------------------------------------------------------
Total                                                                                                        742
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 34144]]

    These estimates are based on FDA's experience with the Cosmetic 
Product Voluntary Reporting Program. The estimated annual total hour 
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: June 6, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11641 Filed 6-10-05; 8:45 am]
BILLING CODE 4160-01-S