82 FR 37100 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cosmetic Labeling Regulations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 151 (August 8, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 151 (August 8, 2017)
| Page Range | 37100-37101 | |
| FR Document | 2017-16649 |
[Federal Register Volume 82, Number 151 (Tuesday, August 8, 2017)] [Notices] [Pages 37100-37101] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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, [email protected]. 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
![37100 Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices
reporting frequency when submitting a described in the previous paragraph on the proposed extension of this
PBRER. FDA expects approximately 29 would be on average approximately 2 collection of information. No comments
applicants to make these submissions, hours for each waiver request. were received.
and we estimate that the time for In the Federal Register of May 23,
We therefore estimate the burden of
submitting the additional information 2017 (82 FR 23578), we published a 60-
this collection of information as follows:
day notice requesting public comment
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Additional information and/or Number of Average
notifications for using a different data Number of Total annual
responses per burden per Total hours
lock point and/or a different reporting respondents responses
respondent response
frequency
Applicants that have a PSUR waiver for an approved ap-
plication ............................................................................ 55 3.4 187 1 187
Applicants that do not have a PSUR waiver for an ap-
proved application ............................................................ 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. comments be faxed to the Office of 371, and 374) and sections 4 and 5 of
Anna K. Abram, Information and Regulatory Affairs, the FPLA (15 U.S.C. 1453 and 1454)
Deputy Commissioner for Policy, Planning, OMB, Attn: FDA Desk Officer, FAX: provide authority to FDA to regulate the
Legislation, and Analysis. 202–395–7285, or emailed to oira_ labeling of cosmetic products. Failure to
[FR Doc. 2017–16647 Filed 8–7–17; 8:45 am] submission@omb.eop.gov. All comply with the requirements for
BILLING CODE 4164–01–P comments should be identified with the cosmetic labeling may render a cosmetic
OMB control number 0910–0599. Also adulterated under section 601 of the
include the FDA docket number found FD&C Act or misbranded under section
DEPARTMENT OF HEALTH AND in brackets in the heading of this 602 of the FD&C Act.
HUMAN SERVICES document. FDA’s cosmetic labeling regulations
FOR FURTHER INFORMATION CONTACT: Ila are published in part 701 (21 CFR part
Food and Drug Administration 701). Four of the cosmetic labeling
S. Mizrachi, Office of Operations, Food
[Docket No. FDA–2017–N–1848] and Drug Administration, Three White regulations have information collection
Flint North, 10A63, 11601 Landsdown provisions. Section 701.3 requires the
Agency Information Collection label of a cosmetic product to bear a
Activities; Submission for Office of St., North Bethesda, MD 20852, 301–
796–7726, PRAStaff@fda.hhs.gov. declaration of the ingredients in
Management and Budget Review; descending order of predominance.
Comment Request; Cosmetic Labeling SUPPLEMENTARY INFORMATION: In Section 701.11 requires the principal
Regulations compliance with 44 U.S.C. 3507, FDA display panel of a cosmetic product to
has submitted the following proposed bear a statement of the identity of the
AGENCY: Food and Drug Administration, collection of information to OMB for
HHS. product. Section 701.12 requires the
review and clearance. label of a cosmetic product to specify
ACTION: Notice.
Cosmetic Labeling Regulations—21 CFR the name and place of business of the
SUMMARY: The Food and Drug Part 701 manufacturer, packer, or distributor.
Administration (FDA, the Agency, or Section 701.13 requires the label of a
we) is announcing that a proposed OMB Control Number 0910–0599— cosmetic product to declare the net
collection of information has been Extension quantity of contents of the product.
submitted to the Office of Management The Federal Food, Drug, and Cosmetic In the Federal Register of May 23,
and Budget (OMB) for review and Act (the FD&C Act) and the Fair 2017 (82 FR 23576), FDA published a
clearance under the Paperwork Packaging and Labeling Act (the FPLA) 60-day notice requesting public
Reduction Act of 1995 (PRA). require that cosmetic manufacturers, comment on the proposed collection of
DATES: Fax written comments on the packers, and distributors disclose information. One comment was received
collection of information by September information about themselves or their which described ingredients used in the
7, 2017. products on the labels or labeling of creation of cosmetics but was not PRA-
ADDRESSES: To ensure that comments on their products. Sections 201, 301, 502, related and will not be addressed here.
the information collection are received, 601, 602, 603, 701, and 704 of the FD&C FDA estimates the burden of this
OMB recommends that written Act (21 U.S.C. 321, 352, 361, 362, 363, collection of information as follows:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
21 CFR section/activity burden per Total hours
respondents per disclosures disclosure
respondent
701.3—Ingredients in order of predominance ..................... 1,518 21 31,878 1 31,878
701.11—Statement of identity ............................................. 1,518 24 36,432 1 36,432
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![Federal Register / Vol. 82, No. 151 / Tuesday, August 8, 2017 / Notices 37101
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of Average
Number of disclosures Total annual
21 CFR section/activity burden per Total hours
respondents per disclosures disclosure
respondent
701.12—Name and place of business ................................ 1,518 24 36,432 1 36,432
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 per year. Therefore, we estimate that the OMB recommends that written
incremental time that establishments number of disclosures per respondent comments be faxed to the Office of
need to design and print labeling that will be 21 (31,878 SKUs) for § 701.3 and Information and Regulatory Affairs,
includes the following required 24 each (36,432 SKUs) for §§ 701.11, OMB, Attn: FDA Desk Officer, FAX:
elements: A declaration of ingredients 701.12, and 701.13. 202–395–7285, or emailed to oira_
in decreasing order of predominance, a We estimate that each of the required submission@omb.eop.gov. All
statement of the identity of the product, label elements may add approximately 1 comments should be identified with the
a specification of the name and place of hour to the label design process. We OMB control number 0910–0614. Also
business of the establishment, and a base this estimate on the hour burdens include the FDA docket number found
declaration of the net quantity of the Agency has previously estimated for in brackets in the heading of this
contents. These requirements increase food, drug, and medical device labeling document.
the time establishments need to design and on the Agency’s knowledge of
FOR FURTHER INFORMATION CONTACT:
labels because they increase the number cosmetic labeling. Therefore, we
of label elements that establishments estimate that the total hour burden on Domini Bean, Office of Operations,
must take into account when designing members of the public for this Food and Drug Administration, Three
labels. These requirements do not information collection is 141,174 hours White Flint North, 10A63, 11601
generate any recurring burden per label per year. Landsdown St., North Bethesda, MD
because establishments must already 20852, 301–796–5733, PRAStaff@
Dated: August 2, 2017. fda.hhs.gov.
print and affix labels to cosmetic Anna K. Abram,
products as part of normal business SUPPLEMENTARY INFORMATION: In
Deputy Commissioner for Policy, Planning,
practices. Legislation, and Analysis. compliance with 44 U.S.C. 3507, FDA
The estimated annual third-party [FR Doc. 2017–16649 Filed 8–7–17; 8:45 am] has submitted the following proposed
disclosure is based on data available to collection of information to OMB for
BILLING CODE 4164–01–P
the Agency, our knowledge of and review and clearance.
experience with cosmetic labeling, and
our communications with industry. We Exceptions or Alternatives to Labeling
DEPARTMENT OF HEALTH AND Requirements for Products Held by the
estimate there are 1,518 cosmetic HUMAN SERVICES
product establishments in the United Strategic National Stockpile; OMB
States. We calculate label design costs Control Number 0910–0614—Extension
Food and Drug Administration
based on stock keeping units (SKUs) Under the Public Health Service Act
[Docket No. FDA–2010–N–0588]
because each SKU has a unique product (PHS Act), the Department of Health
label. Based on data available to the Agency Information Collection and Human Services stockpiles medical
Agency and on communications with Activities; Submission for Office of products that are essential to the health
industry, we estimate that cosmetic Management and Budget Review; security of the Nation (see the PHS Act,
establishments will offer 94,800 SKUs Comment Request; Exceptions or 42 U.S.C. 247d–6b). This collection of
for retail sale in 2017. This corresponds Alternatives to Labeling Requirements medical products for use during
to an average of 62 SKUs per for Products Held by the Strategic national health emergencies, known as
establishment. National Stockpile the Strategic National Stockpile (SNS),
One of the four provisions that we is to ‘‘provide for the emergency health
discuss in this information collection, AGENCY: Food and Drug Administration, security of the United States, including
§ 701.3, applies only to cosmetic HHS. the emergency health security of
products offered for retail sale. ACTION: Notice. children and other vulnerable
However, the other three provisions, populations, in the event of a
§§ 701.11, 701.12, and 701.13, apply to SUMMARY: The Food and Drug bioterrorist attack or other public health
all cosmetic products, including non- Administration (FDA) is announcing emergency.’’ It may be appropriate for
retail professional-use-only products. that a proposed collection of certain medical products that are or will
We estimate that including professional- information has been submitted to the
asabaliauskas on DSKBBXCHB2PROD with NOTICES
be held in the SNS to be labeled in a
use-only cosmetic products increases Office of Management and Budget manner that would not comply with
the total number of SKUs by 15 percent (OMB) for review and clearance under certain FDA labeling regulations given
to 109,020. This corresponds to an the Paperwork Reduction Act of 1995. their anticipated circumstances of use in
average of 72 SKUs per establishment. DATES: Fax written comments on the an emergency. However, noncompliance
Finally, based on the Agency’s collection of information by September with these labeling requirements could
experience with other products, we 7, 2017. render such products misbranded under
estimate that cosmetic establishments ADDRESSES: To ensure that comments on section 502 of the Federal Food, Drug,
may redesign up to one-third of SKUs the information collection are received, and Cosmetic Act (21 U.S.C. 352).
VerDate Sep<11>2014 21:16 Aug 07, 2017 Jkt 241001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\08AUN1.SGM 08AUN1](https://thefederalregister.org/doc/82_FR_37251/page/2.svg)
Document Created: 2017-08-08 00:17:25
Document Modified: 2017-08-08 00:17:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by September 7, 2017. | |
| 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, [email protected] | |
| FR Citation | 82 FR 37100 |
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