Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cosmetic Labeling Regulations, 30035-30036 [2010-13075]

Download as PDF 30035 Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Notices jlentini on DSKJ8SOYB1PROD with NOTICES Bioterrorism Act and presenting it in a format that will meet the agency’s registration regulations will require a burden of approximately 2.5 hours per average domestic facility registration. The average domestic facility burden hour estimate of 2.5 hours takes into account that some respondents completing the registration may not have readily available Internet access. Thus, the total annual burden for new domestic facility registrations is estimated to be 33,900 hours (13,560 x 2.5 hours). FDA received 25,513 new foreign facility registrations during 2006; 23,302 during 2007; and 21,281 during 2008. Based on this experience, FDA estimates the annual number of new foreign facility registrations will be 23,370. FDA estimates that listing the information required by the Bioterrorism Act and presenting it in a format that will meet the agency’s registration regulations will require a burden of approximately 8.5 hours per average foreign facility registration. The average foreign facility burden hour estimate of 8.5 hours includes an estimate of the additional burden on a foreign facility to obtain a U.S. agent, and takes into account that for some foreign facilities the respondent completing the registration may not be fluent in English and/or not have readily available Internet access. Thus, the total annual burden for new foreign facility registrations is estimated to be 198,645 hours (23,370 x 8.5 hours). FDA received 114,199 updates to facility registrations during 2006; 128,070 during 2007; and 113,318 during 2008. Based on this experience, FDA estimates that it will receive 118,530 updates annually. FDA also estimates that updating a registration will, on average, require a burden of approximately 1 hour, taking into account fluency in English and Internet access. Thus, the total annual burden for updating all registrations is estimated to be 118,530 hours. FDA received 5,703 cancellations of facility registrations during 2006; 5,578 during 2007; and 7,888 during 2008. Based on this experience, FDA estimates the annual number of cancellations will be 6,390. FDA also estimates that cancelling a registration will, on average, require a burden of approximately 1 hour, taking into account fluency in English and Internet access. Thus, the total annual burden for cancelling registrations is estimated to be 6,390 hours. Dated: May 25, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–13003 Filed 5–27–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0120] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cosmetic Labeling Regulations 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 (the PRA). DATES: Fax written comments on the collection of information by June 28, 2010.. 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: 202–395–7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0599. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: 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. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed SUPPLEMENTARY INFORMATION: collection of information to OMB for review and clearance. Cosmetic Labeling Regulations—(OMB Control Number 0910–0599)—Extension The Federal Food, Drug, and Cosmetic Act (the act) and the Fair Packaging and Labeling Act (the FPLA) require that cosmetic manufacturers, packers, and distributors disclose information about themselves or their products on the labels or labeling of their products. Sections 201, 502, 601, 602, 603, 701, and 704 of the act (21 U.S.C. 321, 352, 361, 362, 363, 371, and 374) and sections 4 and 5 of the FPLA (15 U.S.C. 1453 and 1454) provide authority to FDA to regulate the labeling of cosmetic products. Failure to comply with the requirements for cosmetic labeling may render a cosmetic adulterated under section 601 of the act or misbranded under section 602 of the act. FDA’s cosmetic labeling regulations are published in part 701 (21 CFR part 701). Four of the cosmetic labeling regulations have information collection provisions. Section 701.3 requires the label of a cosmetic product to bear a declaration of the ingredients in descending order of predominance. Section 701.11 requires the principal display panel of a cosmetic product to bear a statement of the identity of the product. Section 701.12 requires the label of a cosmetic product to specify the name and place of business of the manufacturer, packer, or distributor. Section 701.13 requires the label of a cosmetic product to declare the net quantity of contents of the product. FDA’s cosmetic labeling regulations remain unchanged by this notice. FDA is publishing this notice in compliance with the PRA. This notice does not represent any new regulatory initiative. In the Federal Register of March 16, 2010 (75 FR 12546), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one letter, containing multiple comments, in response to the notice. One comment expressed strong support for the labeling of cosmetics. Additional comments were outside the scope of the four collection of information topics on which the notice solicits comments and, thus, will not be addressed here. FDA estimates the annual burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN1 21 CFR Section No. of Respondents 701.3 VerDate Mar<15>2010 Annual Frequency of Disclosure 1,518 17:43 May 27, 2010 Jkt 220001 PO 00000 Frm 00069 21 Fmt 4703 Sfmt 4703 Total Annual Disclosures Hours per Disclosure 31,878 E:\FR\FM\28MYN1.SGM Total Hours 1 28MYN1 31,878 30036 Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Notices TABLE 1.—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN1—Continued 21 CFR Section No. of Respondents Annual Frequency of Disclosure Total Annual Disclosures Hours per Disclosure Total Hours 701.11 1,518 24 36,432 1 36,432 701.12 1,518 24 36,432 1 36,432 701.13 1,518 24 36,432 1 36,432 Total jlentini on DSKJ8SOYB1PROD with NOTICES 1 There 141,174 are no capital costs or operating and maintenance costs associated with this collection of information. The hour burden is the additional or incremental time that establishments need to design and print labeling that includes the following required elements: A declaration of ingredients in decreasing order of predominance, a statement of the identity of the product, a specification of the name and place of business of the establishment, and a declaration of the net quantity of contents. These requirements increase the time establishments need to design labels because they increase the number of label elements that establishments must take into account when designing labels. These requirements do not generate any recurring burden per label because establishments must already print and affix labels to cosmetic products as part of normal business practices. According to the 2001 census, there are 1,518 cosmetic product establishments in the United States (U.S. Census Bureau, https:// www.census.gov/epcd/susb/2001/us/ US32562.HTM). FDA calculates label design costs based on stockkeeping units (SKUs) because each SKU has a unique product label. Based on data available to the Agency and on communications with industry, FDA estimates that cosmetic establishments will offer 94,800 SKUs for retail sale in 2010. This corresponds to an average of 62 SKUs per establishment. One of the four provisions that FDA discusses in this information collection, § 701.3, applies only to cosmetic products offered for retail sale. However, the other three provisions, §§ 701.11, 701.12, and 701.13, apply to all cosmetic products, including nonretail professional-use-only products. FDA estimates that including professional-use-only cosmetic products increases the total number of SKUs by 15 percent to 109,020. This corresponds to an average of 72 SKUs per establishment. Finally, based on the Agency’s experience with other products, FDA estimates that cosmetic establishments may redesign up to one-third of SKUs VerDate Mar<15>2010 17:43 May 27, 2010 Jkt 220001 per year. Therefore, FDA estimates that the annual frequency of response will be 21 (31,878 SKUs) for § 701.3 and 24 each (36,432 SKUs) for §§ 701.11, 701.12, and 701.13. FDA estimates that each of the required label elements may add approximately 1 hour to the label design process. FDA bases this estimate on the hour burdens the Agency has previously estimated for food, drug, and medical device labeling and on the Agency’s knowledge of cosmetic labeling. Therefore, FDA estimates that the total hour burden on members of the public for this information collection is 141,174 hours per year. Dated: May 25, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–13075 Filed 5–27–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0118] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 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 June 28, 2010. PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 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: 202–395–7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0520. Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002—(OMB Control Number 0910–0520)—Extension The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) added section 801(m) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381(m)), which requires that FDA receive prior notice for food, including food for animals, that is imported or offered for import into the United States. Sections 1.278 through 1.282 of FDA’s regulations (21 CFR 1.278 through 1.282) set forth the requirements for submitting prior notice; §§ 1.283(d) and 1.285(j) (21 CFR 1.283(d) and 1.285(j)) set forth the procedure for requesting FDA review after an article of food has been refused admission under section 801(m)(1) of the act or placed under hold under section 801(l) of the act; and § 1.285(i) (21 CFR 1.285(i)) sets forth the procedure for post-hold submissions. Advance notice of imported food allows FDA, with the support of the U.S. E:\FR\FM\28MYN1.SGM 28MYN1

Agencies

[Federal Register Volume 75, Number 103 (Friday, May 28, 2010)]
[Notices]
[Pages 30035-30036]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13075]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0120]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Cosmetic Labeling 
Regulations

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 (the PRA).

DATES: Fax written comments on the collection of information by June 
28, 2010..

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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0599. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Cosmetic Labeling Regulations--(OMB Control Number 0910-0599)--
Extension

    The Federal Food, Drug, and Cosmetic Act (the act) and the Fair 
Packaging and Labeling Act (the FPLA) require that cosmetic 
manufacturers, packers, and distributors disclose information about 
themselves or their products on the labels or labeling of their 
products. Sections 201, 502, 601, 602, 603, 701, and 704 of the act (21 
U.S.C. 321, 352, 361, 362, 363, 371, and 374) and sections 4 and 5 of 
the FPLA (15 U.S.C. 1453 and 1454) provide authority to FDA to regulate 
the labeling of cosmetic products. Failure to comply with the 
requirements for cosmetic labeling may render a cosmetic adulterated 
under section 601 of the act or misbranded under section 602 of the 
act.
    FDA's cosmetic labeling regulations are published in part 701 (21 
CFR part 701). Four of the cosmetic labeling regulations have 
information collection provisions. Section 701.3 requires the label of 
a cosmetic product to bear a declaration of the ingredients in 
descending order of predominance. Section 701.11 requires the principal 
display panel of a cosmetic product to bear a statement of the identity 
of the product. Section 701.12 requires the label of a cosmetic product 
to specify the name and place of business of the manufacturer, packer, 
or distributor. Section 701.13 requires the label of a cosmetic product 
to declare the net quantity of contents of the product.
    FDA's cosmetic labeling regulations remain unchanged by this 
notice. FDA is publishing this notice in compliance with the PRA. This 
notice does not represent any new regulatory initiative.
    In the Federal Register of March 16, 2010 (75 FR 12546), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one letter, containing multiple 
comments, in response to the notice. One comment expressed strong 
support for the labeling of cosmetics. Additional comments were outside 
the scope of the four collection of information topics on which the 
notice solicits comments and, thus, will not be addressed here.
    FDA estimates the annual burden of this collection of information 
as follows:

                                               Table 1.--Estimated Annual Third Party Disclosure Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of       Annual Frequency  of     Total Annual        Hours per
                    21 CFR Section                         Respondents          Disclosure          Disclosures         Disclosure        Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
701.3                                                               1,518                    21             31,878                  1             31,878
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 30036]]

 
701.11                                                              1,518                    24             36,432                  1             36,432
--------------------------------------------------------------------------------------------------------------------------------------------------------
701.12                                                              1,518                    24             36,432                  1             36,432
--------------------------------------------------------------------------------------------------------------------------------------------------------
701.13                                                              1,518                    24             36,432                  1             36,432
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                   .................  ....................  .................  .................            141,174
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The hour burden is the additional or incremental time that 
establishments need to design and print labeling that includes the 
following required elements: A declaration of ingredients in decreasing 
order of predominance, a statement of the identity of the product, a 
specification of the name and place of business of the establishment, 
and a declaration of the net quantity of contents. These requirements 
increase the time establishments need to design labels because they 
increase the number of label elements that establishments must take 
into account when designing labels. These requirements do not generate 
any recurring burden per label because establishments must already 
print and affix labels to cosmetic products as part of normal business 
practices.
    According to the 2001 census, there are 1,518 cosmetic product 
establishments in the United States (U.S. Census Bureau, https://www.census.gov/epcd/susb/2001/us/US32562.HTM). FDA calculates label 
design costs based on stockkeeping units (SKUs) because each SKU has a 
unique product label. Based on data available to the Agency and on 
communications with industry, FDA estimates that cosmetic 
establishments will offer 94,800 SKUs for retail sale in 2010. This 
corresponds to an average of 62 SKUs per establishment.
    One of the four provisions that FDA discusses in this information 
collection, Sec.  701.3, applies only to cosmetic products offered for 
retail sale. However, the other three provisions, Sec. Sec.  701.11, 
701.12, and 701.13, apply to all cosmetic products, including non-
retail professional-use-only products. FDA estimates that including 
professional-use-only cosmetic products increases the total number of 
SKUs by 15 percent to 109,020. This corresponds to an average of 72 
SKUs per establishment.
    Finally, based on the Agency's experience with other products, FDA 
estimates that cosmetic establishments may redesign up to one-third of 
SKUs per year. Therefore, FDA estimates that the annual frequency of 
response will be 21 (31,878 SKUs) for Sec.  701.3 and 24 each (36,432 
SKUs) for Sec. Sec.  701.11, 701.12, and 701.13.
    FDA estimates that each of the required label elements may add 
approximately 1 hour to the label design process. FDA bases this 
estimate on the hour burdens the Agency has previously estimated for 
food, drug, and medical device labeling and on the Agency's knowledge 
of cosmetic labeling. Therefore, FDA estimates that the total hour 
burden on members of the public for this information collection is 
141,174 hours per year.

    Dated: May 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13075 Filed 5-27-10; 8:45 am]
BILLING CODE 4160-01-S
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