Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cosmetic Labeling Regulations, 36069-36070 [2014-14768]

Download as PDF Federal Register / Vol. 79, No. 122 / Wednesday, June 25, 2014 / Notices Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Mailstop A–19, 1600 Clifton Road NE., Atlanta, Georgia 30333. Instructions: All submissions received must include the agency name and docket number. All relevant comments received will be posted without change to https://regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Skip Wolfe (crw4@cdc.gov), National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Mailstop A–19, 1600 Clifton Road NE., Atlanta, Georgia 30329. The National Childhood Vaccine Injury Act of 1986 (Pub. L. 99–660), as amended by section 708 of Public Law 103–183, added section 2126 to the Public Health Service Act. Section 2126, codified at 42 U.S.C. 300aa–26, requires the Secretary of Health and Human Services to develop and disseminate vaccine information materials for distribution by all health care providers in the United States to any patient (or to the parent or legal representative in the case of a child) receiving vaccines covered under the National Vaccine Injury Compensation Program (VICP). Development and revision of the vaccine information materials, also known as Vaccine Information Statements (VIS), have been delegated by the Secretary to the Centers for Disease Control and Prevention (CDC). Section 2126 requires that the materials be developed, or revised, after notice to the public, with a 60-day comment period, and in consultation with the Advisory Commission on Childhood Vaccines, appropriate health care provider and parent organizations, and the Food and Drug Administration. The law also requires that the information contained in the materials be based on available data and information, be presented in understandable terms, and include: (1) A concise description of the benefits of the vaccine, (2) A concise description of the risks associated with the vaccine, (3) A statement of the availability of the National Vaccine Injury Compensation Program, and (4) Such other relevant information as may be determined by the Secretary. The vaccines initially covered under the National Vaccine Injury Compensation Program were diphtheria, tetanus, pertussis, measles, mumps, mstockstill on DSK4VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 18:01 Jun 24, 2014 Jkt 232001 rubella and poliomyelitis vaccines. Since April 15, 1992, any health care provider in the United States who intends to administer one of these covered vaccines is required to provide copies of the relevant vaccine information materials prior to administration of any of these vaccines. Since then, the following vaccines have been added to the National Vaccine Injury Compensation Program, requiring use of vaccine information materials for them as well: Hepatitis B, Haemophilus influenzae type b (Hib), varicella (chickenpox), pneumococcal conjugate, rotavirus, hepatitis A, meningococcal, human papillomavirus (HPV), and seasonal influenza vaccines. Instructions for use of the vaccine information materials and copies of the materials can be found on the CDC Web site at: https://www.cdc.gov/vaccines/ hcp/vis/. HHS/CDC is proposing updated versions of the Td, Tdap, Hib, and rotavirus vaccine information statements. We also propose to revise the August 26, 2013 Instructions for the Use of Vaccine Information Statements to include a reference to these vaccine information materials. The vaccine information materials referenced in this notice are being developed in consultation with the Advisory Commission on Childhood Vaccines, the Food and Drug Administration, and parent and health care provider groups. We invite written comment on the proposed vaccine information materials entitled ‘‘Td Vaccine: What You Need to Know;’’ ‘‘Tdap Vaccine: What You Need to Know;’’ ‘‘Haemophilus influenzae type b Vaccine: What You need to Know;’’ and ‘‘Rotavirus Vaccine: What You Need to Know.’’ Copies of the proposed vaccine information materials are available at https:// www.regulations.gov (see Docket Number CDC–2014–0007). Comments submitted will be considered in finalizing these materials. When the final materials are published in the Federal Register, the notice will include an effective date for their mandatory use. Ron A. Otten, Acting Deputy Associate Director for Science, Centers for Disease Control and Prevention. [FR Doc. 2014–14805 Filed 6–24–14; 8:45 am] BILLING CODE 4163–18–P PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 36069 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. 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 July 25, 2014. 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 emailed 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: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. 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. SUMMARY: Cosmetic Labeling Regulations—21 CFR Part 701 (OMB Control Number 0910– 0599)—Extension The Federal Food, Drug, and Cosmetic Act (the FD&C 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, 301, 502, 601, 602, 603, 701, and 704 of the FD&C Act (21 U.S.C. 321, 331, 352, 361, 362, 363, 371, and 374, respectively) 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 E:\FR\FM\25JNN1.SGM 25JNN1 36070 Federal Register / Vol. 79, No. 122 / Wednesday, June 25, 2014 / Notices products. Failure to comply with the requirements for cosmetic labeling may render a cosmetic adulterated under section 601 of the FD&C Act or misbranded under section 602 of the FD&C 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. In the Federal Register of April 17, 2014 (79 FR 21766), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1 Number of respondents 21 CFR Section/Activity Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours 701.3/Ingredients in order of predominance ........................ 701.11/Statement of identity ................................................ 701.12/Name and place of business ................................... 701.13/Net quantity of contents ........................................... 1,518 1,518 1,518 1,518 21 24 24 24 31,878 36,432 36,432 36,432 1 1 1 1 31,878 36,432 36,432 36,432 Total .............................................................................. ........................ ........................ ........................ ........................ 141,174 mstockstill on DSK4VPTVN1PROD with NOTICES 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. The estimated annual third party disclosure is based on data available to the Agency, our knowledge of and experience with cosmetic labeling, and our communications with industry. We estimate there are 1,518 cosmetic product establishments in the United States. We calculate label design costs based on stock keeping units (SKUs) because each SKU has a unique product label. Based on data available to the Agency and on communications with industry, we estimate that cosmetic establishments will offer 94,800 SKUs for retail sale in 2014. This corresponds to an average of 62 SKUs per establishment. One of the four provisions that we discuss in this information collection, § 701.3, applies only to cosmetic products offered for retail sale. VerDate Mar<15>2010 18:01 Jun 24, 2014 Jkt 232001 However, the other three provisions, §§ 701.11, 701.12, and 701.13, apply to all cosmetic products, including nonretail professional-use-only products. We estimate that including professionaluse-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, we estimate that cosmetic establishments may redesign up to one-third of SKUs per year. Therefore, we estimate that the number of disclosures per respondent will be 21 (31,878 SKUs) for § 701.3 and 24 each (36,432 SKUs) for §§ 701.11, 701.12, and 701.13. We estimate that each of the required label elements may add approximately 1 hour to the label design process. We base this estimate on the burden hours the Agency has previously estimated for food, drug, and medical device labeling and on the Agency’s knowledge of cosmetic labeling. Therefore, we estimate that the total burden hours on members of the public for this information collection are 141,174 hours per year. Dated: June 19, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–14768 Filed 6–24–14; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0493] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Criteria and Procedures for Classifying Overthe-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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 July 25, 2014. 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 emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0688. Also include the FDA docket number found in brackets in the heading of this document. SUMMARY: E:\FR\FM\25JNN1.SGM 25JNN1

Agencies

[Federal Register Volume 79, Number 122 (Wednesday, June 25, 2014)]
[Notices]
[Pages 36069-36070]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14768]

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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.

DATES: Fax written comments on the collection of information by July
25, 2014.

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 emailed 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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--21 CFR Part 701 (OMB Control Number
0910-0599)--Extension

The Federal Food, Drug, and Cosmetic Act (the FD&C 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, 301, 502, 601, 602, 603, 701, and 704 of the
FD&C Act (21 U.S.C. 321, 331, 352, 361, 362, 363, 371, and 374,
respectively) 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

[[Page 36070]]

products. Failure to comply with the requirements for cosmetic labeling
may render a cosmetic adulterated under section 601 of the FD&C Act or
misbranded under section 602 of the FD&C 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.
In the Federal Register of April 17, 2014 (79 FR 21766), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Third Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section/Activity Number of disclosures Total annual burden per Total hours
respondents per respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
701.3/Ingredients in order of 1,518 21 31,878 1 31,878
predominance...................
701.11/Statement of identity.... 1,518 24 36,432 1 36,432
701.12/Name and place of 1,518 24 36,432 1 36,432
business.......................
701.13/Net quantity of contents. 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.
The estimated annual third party disclosure is based on data
available to the Agency, our knowledge of and experience with cosmetic
labeling, and our communications with industry. We estimate there are
1,518 cosmetic product establishments in the United States. We
calculate label design costs based on stock keeping units (SKUs)
because each SKU has a unique product label. Based on data available to
the Agency and on communications with industry, we estimate that
cosmetic establishments will offer 94,800 SKUs for retail sale in 2014.
This corresponds to an average of 62 SKUs per establishment.
One of the four provisions that we discuss 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. We estimate 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, we
estimate that cosmetic establishments may redesign up to one-third of
SKUs per year. Therefore, we estimate that the number of disclosures
per respondent 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.
We estimate that each of the required label elements may add
approximately 1 hour to the label design process. We base this estimate
on the burden hours the Agency has previously estimated for food, drug,
and medical device labeling and on the Agency's knowledge of cosmetic
labeling. Therefore, we estimate that the total burden hours on members
of the public for this information collection are 141,174 hours per
year.

Dated: June 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14768 Filed 6-24-14; 8:45 am]
BILLING CODE 4164-01-P

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