Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cosmetic Labeling Regulations, 37100-37101 [2017-16649]

Download as PDF 37100 Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices reporting frequency when submitting a PBRER. FDA expects approximately 29 applicants to make these submissions, and we estimate that the time for submitting the additional information described in the previous paragraph would be on average approximately 2 hours for each waiver request. In the Federal Register of May 23, 2017 (82 FR 23578), we published a 60day notice requesting public comment on the proposed extension of this collection of information. No comments were received. We therefore estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Additional information and/or notifications for using a different data lock point and/or a different reporting frequency Number of respondents Number of responses per respondent Average burden per response Total annual responses Total hours Applicants that have a PSUR waiver for an approved application ............................................................................ Applicants that do not have a PSUR waiver for an approved application ............................................................ 55 3.4 187 1 187 29 2.3 67 2 134 Total .............................................................................. ........................ ........................ ........................ ........................ 321 1 There are no capital or operating and maintenance costs associated with the information collection. Dated: August 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. DEPARTMENT OF HEALTH AND HUMAN SERVICES 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. Food and Drug Administration FOR FURTHER INFORMATION CONTACT: [FR Doc. 2017–16647 Filed 8–7–17; 8:45 am] BILLING CODE 4164–01–P [Docket No. FDA–2017–N–1848] 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, the Agency, or we) 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 (PRA). DATES: Fax written comments on the collection of information by September 7, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written asabaliauskas on DSKBBXCHB2PROD with NOTICES SUMMARY: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301– 796–7726, 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, 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 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 May 23, 2017 (82 FR 23576), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received which described ingredients used in the creation of cosmetics but was not PRArelated and will not be addressed here. 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 701.3—Ingredients in order of predominance ..................... 701.11—Statement of identity ............................................. VerDate Sep<11>2014 21:16 Aug 07, 2017 Jkt 241001 PO 00000 Frm 00061 Number of disclosures per respondent 1,518 1,518 Fmt 4703 Sfmt 4703 21 24 Total annual disclosures 31,878 36,432 E:\FR\FM\08AUN1.SGM 08AUN1 Average burden per disclosure Total hours 1 1 31,878 36,432 37101 Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued Number of respondents 21 CFR section/activity Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours 701.12—Name and place of business ................................ 701.13—Net quantity of contents ........................................ 1,518 1,518 24 24 36,432 36,432 1 1 36,432 36,432 Total .............................................................................. ........................ ........................ ........................ ........................ 141,174 asabaliauskas on DSKBBXCHB2PROD 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 2017. 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. 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 VerDate Sep<11>2014 21:16 Aug 07, 2017 Jkt 241001 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 hour burdens 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 hour burden on members of the public for this information collection is 141,174 hours per year. Dated: August 2, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–16649 Filed 8–7–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0588] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile 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 September 7, 2017. ADDRESSES: To ensure that comments on the information collection are received, SUMMARY: PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 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 0910–0614. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–5733, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile; OMB Control Number 0910–0614—Extension Under the Public Health Service Act (PHS Act), the Department of Health and Human Services stockpiles medical products that are essential to the health security of the Nation (see the PHS Act, 42 U.S.C. 247d–6b). This collection of medical products for use during national health emergencies, known as the Strategic National Stockpile (SNS), is to ‘‘provide for the emergency health security of the United States, including the emergency health security of children and other vulnerable populations, in the event of a bioterrorist attack or other public health emergency.’’ It may be appropriate for certain medical products that are or will be held in the SNS to be labeled in a manner that would not comply with certain FDA labeling regulations given their anticipated circumstances of use in an emergency. However, noncompliance with these labeling requirements could render such products misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352). E:\FR\FM\08AUN1.SGM 08AUN1

Agencies

[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)]
[Notices]
[Pages 37100-37101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16649]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1848]

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, the Agency, or we) 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 (PRA).

DATES: Fax written comments on the collection of information by
September 7, 2017.

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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
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, 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 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 May 23, 2017 (82 FR 23576), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received which described
ingredients used in the creation of cosmetics but was not PRA-related
and will not be addressed here.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average
21 CFR section/activity respondents per disclosures burden per Total hours
respondent 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

[[Page 37101]]

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 2017.
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 hour burdens 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 hour burden on members
of the public for this information collection is 141,174 hours per
year.

Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16649 Filed 8-7-17; 8:45 am]
BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.