Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Regulations, 12546-12547 [2010-5657]
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12546
Federal Register / Vol. 75, No. 50 / Tuesday, March 16, 2010 / Notices
The MAI Plan Narrative that
accompanies the Plan Web forms
provides (1) an explanation of the data
submitted in the Plan Web forms; (2) a
summary of the Plan, including the plan
and timeline for disbursing funds,
monitoring service delivery, and
implementing any service-related
capacity development or technical
assistance activities; and (3) the plan
and timeline for documenting clientlevel outcome measures. In addition, if
the EMA/TGA revised any planned
services, allocation amounts or target
communities after their grant
application was submitted, the changes
must be highlighted and explained. The
accompanying MAI Annual Report
Narrative describes (1) progress towards
achieving specific goals and objectives
identified in the Grantee’s approved
MAI Plan for that fiscal year and in
linking MAI services/activities to Part A
and other Ryan White HIV/AIDS
Program services; (2) achievements in
relation to client-level health outcomes;
(3) summary of challenges or barriers at
the provider or grantee levels, the
strategies and/or action steps
implemented to address them, and
lessons learned; and, (4) discussion of
MAI technical assistance needs
identified by the EMA/TGA.
This information is needed to monitor
and assess: (1) Changes in the type and
amount of HIV/AIDS health care and
related services being provided to each
disproportionately impacted community
of color; (2) the aggregate number of
persons receiving HIV/AIDS services
within each racial and ethnic
community; and (3) the impact of Part
A MAI-funded services in terms of
client-level and service-level health
outcomes. The information also is used
to plan new technical assistance and
capacity development activities, and
inform the HRSA policy and program
management functions. The data
provided to HRSA does not contain
individual or personally identifiable
information.
The annual estimated response
burden for grantees is as follows:
Form
Estimated
number of
respondents
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
Part A MAI Report ...............................................................
56
2
112
5
560
Note: Data collection system enhancements have resulted in a shortened response burden (from 6 to 5 total hours per response) for respondents since the previous OMB approval request.
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, Maryland 20857. Written
comments should be received within 30
days of this notice.
Dated: March 5, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–5673 Filed 3–15–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0120]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Cosmetic Labeling
Regulations
AGENCY:
Food and Drug Administration,
sroberts on DSKD5P82C1PROD with NOTICES
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
SUPPLEMENTARY INFORMATION:
HHS.
ACTION:
information, 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.
DATES: Submit written or electronic
comments on the collection of
information by May 17, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. 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:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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 each proposed
extension of an existing collection of
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to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
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.
With respect to the following
collection of information, FDA invites
comments on these topics: (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.
Cosmetic Labeling Regulations—21 CFR
Part 701 (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.
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12547
Federal Register / Vol. 75, No. 50 / Tuesday, March 16, 2010 / Notices
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 document.
FDA is publishing this document in
compliance with the PRA. This
document does not represent any new
regulatory initiative.
FDA estimates the annual burden of
this collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
of Disclosure
Total Annual
Disclosures
Hours per
Disclosure
Total Hours
701.3
1,518
21
31,878
1
31,878
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
sroberts on DSKD5P82C1PROD 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
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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 (31,878 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: March 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–5657 Filed 3–15–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0119]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Registration of
Food Facilities 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 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 each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection provisions of
the agency’s regulations that require
registration for domestic and foreign
facilities that manufacture, process,
pack, or hold food for human or animal
consumption in the United States.
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[Federal Register Volume 75, Number 50 (Tuesday, March 16, 2010)]
[Notices]
[Pages 12546-12547]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-5657]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0120]
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 each proposed extension of an existing collection of
information, 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.
DATES: Submit written or electronic comments on the collection of
information by May 17, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. 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: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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
each proposed extension of an existing collection of information,
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.
With respect to the following collection of information, FDA
invites comments on these topics: (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.
Cosmetic Labeling Regulations--21 CFR Part 701 (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.
[[Page 12547]]
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
document. FDA is publishing this document in compliance with the PRA.
This document does not represent any new regulatory initiative.
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 Total Annual Hours per
21 CFR Section Respondents of Disclosure Disclosures Disclosure Total Hours
----------------------------------------------------------------------------------------------------------------
701.3 1,518 21 31,878 1 31,878
----------------------------------------------------------------------------------------------------------------
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: March 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5657 Filed 3-15-10; 8:45 am]
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