Cosmetic Labeling Attachment D 60day pubd

Federal Register / Vol. 71, No. 11 / Wednesday, January 18, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0494]

Agency Information Collection
Activities; Proposed Collection;
Comment Request; Cosmetic Labeling
Regulations
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including collections of
information in current rules, and to
allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection provisions in FDA’s cosmetic
labeling regulations. FDA’s cosmetic
labeling regulations, as published in the
Federal Register on March 15, 1974 (39
FR 10054 at 10056) and subsequently
amended, most recently on March 17,
1999 (64 FR 13254 at 13297), remain
unchanged by this notice. FDA is
publishing this notice in compliance
with the PRA. This notice does not
represent any new regulatory initiative.
DATES: Submit written or electronic
comments on the collection of
information by March 20, 2006.
ADDRESSES: Submit electronic
comments on the collection of
information to: http://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All

comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–4659.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including collections of information in
current rules, before submitting the
collection to OMB for approval. To
comply with this requirement, FDA is
publishing notice of the proposed
collection of information set forth in
this document.
Under section 3506(c)(2)(A) of the
PRA and 5 CFR 1320.8(d)(1), FDA
invites comments on: (1) Whether the
proposed collection of information is
necessary for the proper performance of
FDA’s functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.

2947

Cosmetic Labeling Regulations—(21
CFR Part 701)
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,
as published in the Federal Register on
March 15, 1974 (39 FR 10054 at 10056)
and subsequently amended, most
recently on March 17, 1999 (64 FR
13254 at 13297), remain unchanged by
this notice. FDA is publishing this
notice in compliance with the PRA.
This notice does not represent any new
regulatory initiative.
FDA estimates the annual burden of
this collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

erjones on PROD1PC68 with NOTICES

21 CFR Section

No. of
Respondents

Annual Frequency
per Response

Total Annual
Responses

Hours per
Response

Total Hours

701.3

1518

21

31,600

1.00

31,600

701.11

1518

24

36,340

1.00

36,340

701.12

1518

24

36,340

1.00

36,340

701.13

1518

24

36,340

1.00

36,340

Total
1There

140,620
are no capital costs or operating and maintenance costs associated with this collection of information.

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2948

Federal Register / Vol. 71, No. 11 / Wednesday, January 18, 2006 / Notices

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, http://
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
2005. 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
per year. Therefore, FDA estimates that
the annual frequency of response will be
21 (31,600 SKUs) for § 701.3 and 24
each (36,340 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

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for this information collection is
140,620 hours per year.
Dated: January 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–443 Filed 1–17–06; 8:45 am]
BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND
SECURITY
Bureau of Customs and Border
Protection
[USCBP–2006–0010]

Proposed Collection; Comment
Request; Guam Visa Waiver
Information (I–736)
Customs and Border Protection
(CBP), Department of Homeland
Security.
ACTION: Notice and request for
comments.
AGENCY:

SUMMARY: As part of its continuing effort
to reduce paperwork and respondent
burden, Customs and Border Protection
(CBP) invites the general public and
other Federal agencies to comment on
an information collection requirement
concerning the Guam Visa Waiver
Information. This proposed information
collection was previously published in
the Federal Register (70 FR 58452–
58453) on October 6, 2005, allowing for
a 60-day comment period. This notice
allows for an additional 30 days for
public comments. This request for
comment is being made pursuant to the
Paperwork Reduction Act of 1995 (Pub.
L. 104–13; 44 U.S.C. 3505(c)(2)).
DATES: Written comments should be
received on or before February 17, 2006,
to be assured of consideration.
ADDRESSES: Direct all written comments
to the Bureau of Customs and Border
Protection, Attn: Tracey Denning,
Information Services Group, Room
3.2.C, 1300 Pennsylvania Avenue, NW.,
Washington, DC 20229.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to the Bureau of
Customs and Border Protection, Attn.:
Tracey Denning, Room 3.2.C, 1300
Pennsylvania Avenue, NW.,
Washington, DC 20229, Tel. (202) 344–
1429.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (Pub. L. 104–13;
44 U.S.C. 3505(c)(2)). The comments

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should address: (a) Whether the
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimates of the burden of the
collection of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; (d)
ways to minimize the burden including
the use of automated collection
techniques or the use of other forms of
information technology; and (e)
estimates of capital or start-up costs and
costs of operations, maintenance, and
purchase of services to provide
information. The comments that are
submitted will be summarized and
included in the CBP request for Office
of Management and Budget (OMB)
approval. All comments will become a
matter of public record. In this
document Customs is soliciting
comments concerning the following
information collection:
Title: Guam Visa Waiver Information.
OMB Number: 1651–0109.
Form Number: CBP Form I–736.
Abstract: The CBP Form I–736 is used
to track an alien’s application for waiver
of the nonimmigrant visa requirement
for entry into Guam.
Current Actions: There are no changes
to the information collection. This
submission is being submitted to extend
the expiration date.
Type of Review: Extension.
Affected Public: Individuals.
Estimated Number of Respondents:
170,000.
Estimated Time per Respondent: 5
minutes.
Estimated Total Annual Burden
Hours: 14,110.
Estimated Total Annualized Cost on
the Public: N/A.
Dated: January 10, 2006.
Tracey Denning,
Agency Clearance Officer, Information
Services Branch.
[FR Doc. 06–423 Filed 1–17–06; 8:45 am]
BILLING CODE 9111–14–P

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