Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Registration of Cosmetic Product Establishments, 65041-65042 [E7-22588]

Download as PDF 65041 Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices TABLE 4.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED UNLICENSED MIXER-FEEDERS)1 No. of Recordkeepers 21 CFR Section Annual Frequency per Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 225.142 45,000 4 180,000 1 180,000 225.158 45,000 1 45,000 4 180,000 225.180 45,000 32 1,440,000 .12 172,000 225.202 45,000 260 11,700,000 .33 3,861,000 Total 4,393,000 1There are no capital costs or operating and maintenance costs associated with this collection of information. The estimate of the times required for record preparation and maintenance is based on agency communications with industry. Other information needed to finally calculate the total burden hours (i.e., number of recordkeepers, number of medicated feeds being manufactured, etc.) is derived from agency records and experience. Dated: November 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–22587 Filed 11–16–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N–0278] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Registration of Cosmetic Product Establishments AGENCY: Food and Drug Administration, HHS. rwilkins on PROD1PC63 with NOTICES 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 December 19, 2007. 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: VerDate Aug<31>2005 20:17 Nov 16, 2007 Jkt 214001 202–395–6974, or e-mailed to baguilar@omb.eop.gov. All comments should be identified with the OMB control number 0910–0027. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. 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. Voluntary Registration of Cosmetic Product Establishments—(OMB Control Number 0910–0027)—Extension The Federal Food, Drug, and Cosmetic Act (the act) provides FDA with the responsibility for assuring consumers that cosmetic products in the United States are safe and properly labeled. 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) may not be distributed in interstate commerce. To assist FDA in carrying out its responsibility to regulate cosmetics, FDA has developed the Voluntary Cosmetic Registration Program (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 https://www.cfsan.fda.gov/~dms/cosregn.html. FDA’s online registration system, intended to make it easier to PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 participate in the VCRP, was made available industry-wide 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. Submission of the paper version of Form FDA 2511 remains an option as described in https:// www.cfsan.fda.gov/~dms/cos-reg2.html. However, due to the high volume of online participation, the VCRP is allocating its limited resources primarily to electronic registrations. 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 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 the Federal Register of July 19, 2007 (72 FR 39626), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this information collection as follows: E:\FR\FM\19NON1.SGM 19NON1 65042 Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Part 710 No. of Respondents Form FDA 2511 1There 135 Dated: November 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–22588 Filed 11–16–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006F–0058] ARCH Chemicals, Inc.; Withdrawal of Food Additive Petition FAP 6B4764 AGENCY: Food and Drug Administration, HHS. 1 Hours per Response 135 Total Hours 0.2 Notice. antimicrobial agent in the manufacture of food-contact paper and paperboard. 27 DEPARTMENT OF HEALTH AND HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: Food and Drug Administration Elizabeth S. Furukawa, Center for Food Safety and Applied Nutrition (HFS– 275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740–3835, 301–436–1216, e-mail: Elizabeth.Furukawa@fda.hhs.gov. In a notice published in the Federal Register of February 15, 2006 (71 FR 7975), FDA announced that a food additive petition (FAP 6B4764) had been filed by ARCH Chemicals, Inc., 1955 Lake Park Dr., suite 100, Smyrna, GA 30080. The petition proposed to amend the food additive regulations in 21 CFR 176.170 Components of paper and paperboard in contact with aqueous and fatty foods and 21 CFR 176.180 Components of paper and paperboard in contact with dry food to provide for the safe use of poly (iminoimidocarbonyliminoimido carbonyliminohexamethylene) hydrochloride (CAS Reg. No. 32289–58– 0) as an antimicrobial agent in the manufacture of food-contact paper and paperboard. ARCH Chemicals, Inc., has now withdrawn the petition without prejudice to a future filing (21 CFR 171.7). SUPPLEMENTARY INFORMATION: Dated: November 9, 2007. Laura M. Tarantino, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. E7–22536 Filed 11–16–07; 8:45 am] BILLING CODE 4160–01–S The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 6B4764) proposing that the food additive regulations be amended to provide for the safe use of poly (iminoimidocarbonyliminoimidocarbon yliminohexamethylene) hydrochloride (CAS Reg No. 32289–58–0) as an SUMMARY: rwilkins on PROD1PC63 with NOTICES Total Annual Responses are no capital costs or operating and maintenance costs associated with this collection of information. FDA bases its estimate on its review of the registrations received over the past 3 fiscal years. The total annual responses (averaged over fiscal years 2004 through 2006) is 9 times the previous total reported in 2004 (for fiscal years 2000 through 2003) due to increased participation by cosmetic companies, because of a renewed industry commitment to the program, and implementation of the online registration system on December 1, 2005. Due to the ease of online registration, FDA estimates that the hours per response have declined from 0.4 hours to 0.2 hours. Thus, the total estimated hour burden for this information collection is 27 hours, which is 4.5 times the previous level reported in 2004. ACTION: Annual Frequency per Response VerDate Aug<31>2005 20:17 Nov 16, 2007 Jkt 214001 PO 00000 [FDA 225–07–7001] Memorandum of Understanding Between the Food and Drug Administration and the Association of American Feed Control Officials AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Association of American Feed Control Officials (AAFCO). The purpose of this MOU is to facilitate FDA’s collaboration with AAFCO in the AAFCO New and Modified Ingredient Definition Process by clarifying the responsibilities of FDA and AAFCO in defining feed ingredients, in providing mechanisms for resolving disputes that may arise, and in providing mechanisms for modifying the ingredient definition process when required. DATES: The agreement became effective August 30, 2007. FOR FURTHER INFORMATION CONTACT: Sharon Benz, Division of Animal Feeds (HFV–220), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–453–6864. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which states that all written agreements and MOUs between FDA and others shall be published in the Federal Register, the agency is publishing notice of this MOU. Dated: November 12, 2007. Randall W. Lutter, Deputy Commissioner for Policy. BILLING CODE 4160–01–S Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\19NON1.SGM 19NON1

Agencies

[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Notices]
[Pages 65041-65042]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22588]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0278]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Voluntary 
Registration of Cosmetic Product Establishments

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 
December 19, 2007.

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, or e-mailed to baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0027. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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.

Voluntary Registration of Cosmetic Product Establishments--(OMB Control 
Number 0910-0027)--Extension

    The Federal Food, Drug, and Cosmetic Act (the act) provides FDA 
with the responsibility for assuring consumers that cosmetic products 
in the United States are safe and properly labeled. 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) may not be 
distributed in interstate commerce. To assist FDA in carrying out its 
responsibility to regulate cosmetics, FDA has developed the Voluntary 
Cosmetic Registration Program (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 https://
www.cfsan.fda.gov/~dms/cos-regn.html. FDA's online registration system, 
intended to make it easier to participate in the VCRP, was made 
available industry-wide 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. Submission of the paper 
version of Form FDA 2511 remains an option as described in https://
www.cfsan.fda.gov/~dms/cos-reg2.html. However, due to the high volume 
of online participation, the VCRP is allocating its limited resources 
primarily to electronic registrations.
    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 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 the Federal Register of July 19, 2007 (72 FR 39626), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this information collection as follows:

[[Page 65042]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 No. of        Annual Frequency     Total Annual        Hours per
              21 CFR Part                      Form           Respondents        per Response        Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
710                                              FDA 2511                135                  1                135                0.2                 27
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA bases its estimate on its review of the registrations received 
over the past 3 fiscal years. The total annual responses (averaged over 
fiscal years 2004 through 2006) is 9 times the previous total reported 
in 2004 (for fiscal years 2000 through 2003) due to increased 
participation by cosmetic companies, because of a renewed industry 
commitment to the program, and implementation of the online 
registration system on December 1, 2005. Due to the ease of online 
registration, FDA estimates that the hours per response have declined 
from 0.4 hours to 0.2 hours. Thus, the total estimated hour burden for 
this information collection is 27 hours, which is 4.5 times the 
previous level reported in 2004.

    Dated: November 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22588 Filed 11-16-07; 8:45 am]
BILLING CODE 4160-01-S
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