Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Cosmetic Registration Program, 53877-53878 [E8-21617]
Download as PDF
<![CDATA[
Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Notices
Dated: September 11, 2008.
Maryam Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–21690 Filed 9–16–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0490]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Voluntary
Cosmetic Registration Program
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
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 collection of information associated
with the Voluntary Cosmetic
Registration Program.
DATES: Submit written or electronic
comments on the collection of
information by November 17, 2008.
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:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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.
VerDate Aug<31>2005
17:38 Sep 16, 2008
Jkt 214001
‘‘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.
Voluntary Cosmetic Registration
Program—21 CFR Part 720 (OMB
Control Number 0910–0030)—Extension
The Federal Food, Drug, and Cosmetic
Act (the act) provides FDA with the
authority to regulate cosmetic products
in the United States. Cosmetic products
that are adulterated under section 601 of
the act (21 U.S.C. 361) or misbranded
under section 602 of the act (21 U.S.C.
362) may not be distributed in interstate
commerce. To assist FDA in carrying
out its responsibility to regulate
cosmetics, the agency has developed the
Voluntary Cosmetic Registration
Program (VCRP). In part 720 (21 CFR
part 720), FDA requests that firms that
manufacture, pack, or distribute
cosmetics file with the agency an
ingredient statement for each of their
products. Ingredient statements for new
submissions (§§ 720.1 through 720.4)
are reported on Form FDA 2512,
‘‘Cosmetic Product Ingredient
Statement,’’ and on Form FDA 2512a, a
continuation form. Amendments to
product formulations (§§ 720.3, 720.4,
and 720.6) also are reported on Forms
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
53877
FDA 2512 and FDA 2512a. When a firm
discontinues the commercial
distribution of a cosmetic, FDA requests
that the firm file Form FDA 2514,
‘‘Discontinuance of Commercial
Distribution of Cosmetic Product
Formulation’’ (§§ 720.3 and 720.6). If
any of the information submitted on or
with these forms is confidential, the
firm may submit a request for
confidentiality under § 720.8.
FDA’s online filing system, intended
to make it easier to participate in the
VCRP, was made available industrywide on December 1, 2005. The online
filing system is available on FDA’s
VCRP Web site at https://
www.cfsan.fda.gov/~dms/cosregn.html. The online filing system
contains the electronic versions of
Forms FDA 2512, 2512a, and 2514,
which are collectively found within the
electronic version of Form FDA 2512.
The agency strongly encourages
electronic filing of Form FDA 2512
because it is faster and more convenient.
A filing facility will receive
confirmation of electronic filing by email. Submission of the paper version of
Forms FDA 2512, 2512a, and 2514
remains an option as described in
https://www.cfsan.fda.gov/~dms/cosreg2.html. However, due to the high
volume of online participation, the
VCRP is allocating its limited resources
primarily to electronic filings.
FDA places cosmetic product filing
information in a computer data base and
uses the information for evaluation of
cosmetic products currently on the
market. Because filing of cosmetic
product formulations is not mandatory,
voluntary filings provide FDA with the
best information available about
cosmetic product ingredients and their
frequency of use, businesses engaged in
the manufacture and distribution of
cosmetics, and approximate rates of
product discontinuance and formula
modifications. The information assists
FDA scientists in evaluating reports of
alleged injuries and adverse reactions
from the use of cosmetics. The
information also is used in defining and
planning analytical and toxicological
studies pertaining to cosmetics.
Information from the database is
releasable to the public under FDA
compliance with the Freedom of
Information Act. FDA shares
nonconfidential information from its
files on cosmetics with consumers,
medical professionals, and industry.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\17SEN1.SGM
17SEN1
53878
Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Form No.
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
720.1 through 720.4 (new
submissions)
FDA 25122
141
31
4371
0.33
1,442
720.4 and 720.6 (amendments)
FDA 2512
109
7
763
0.17
130
720.3, 720.6 (notices of discontinuance)
FDA 2512
55
41
2,255
0.1
226
1
1
1
1.5
720.8 (requests for confidentiality)
Total
1.5
1,800
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
term ‘‘Form FDA 2512’’ refers to both the paper Forms FDA 2512, 2512a, and 2514 and electronic Form FDA 2512 in the electronic system known as the Voluntary Cosmetic Registration Program, which is available at https://www.cfsan.fda.gov/~dms/cos-regn.html.
2 The
The estimated number of respondents
is based on submissions received from
fiscal years 2005 to 2007. The estimated
time required for each submission is
based upon information from cosmetic
industry personnel and FDA experience
entering data submitted on paper Forms
FDA 2512, 2512a, and 2514. The
increase in total annual responses is due
to increased participation by cosmetic
companies, because of a renewed
industry commitment to the program,
and implementation of the online filing
system on December 1, 2005. The
decrease in hours per response is due to
the ease of online filing.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: September 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–21617 Filed 9–16–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
pwalker on PROD1PC71 with NOTICES
[Docket No. FDA–2008–N–0487]
Food and Drug Administration,
HHS.
VerDate Aug<31>2005
17:38 Sep 16, 2008
Jkt 214001
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
reinstatement of an existing collection
of information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a voluntary consumer survey about food
safety.
DATES: Submit written or electronic
comments on the collection of
information by November 17, 2008.
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:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
SUPPLEMENTARY INFORMATION:
I. Background
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Safety
Survey
AGENCY:
ACTION:
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
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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 reinstatement
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.
Food Safety Survey (OMB Control
Number 0910–0345—Reinstatement)
Under section 903(b)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
393(b)(2)), FDA is authorized to conduct
research relating to foods and to
conduct educational and public
information programs relating to the
safety of the nation’s food supply. The
Food Safety Survey is a nationally
E:\FR\FM\17SEN1.SGM
17SEN1
]]>Agencies
[Federal Register Volume 73, Number 181 (Wednesday, September 17, 2008)]
[Notices]
[Pages 53877-53878]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21617]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0490]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Voluntary Cosmetic Registration Program
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 collection of information
associated with the Voluntary Cosmetic Registration Program.
DATES: Submit written or electronic comments on the collection of
information by November 17, 2008.
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: Jonna Capezzuto, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3794.
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.
Voluntary Cosmetic Registration Program--21 CFR Part 720 (OMB Control
Number 0910-0030)--Extension
The Federal Food, Drug, and Cosmetic Act (the act) provides FDA
with the authority to regulate cosmetic products in the United States.
Cosmetic products that are adulterated under section 601 of the act (21
U.S.C. 361) or misbranded under section 602 of the act (21 U.S.C. 362)
may not be distributed in interstate commerce. To assist FDA in
carrying out its responsibility to regulate cosmetics, the agency has
developed the Voluntary Cosmetic Registration Program (VCRP). In part
720 (21 CFR part 720), FDA requests that firms that manufacture, pack,
or distribute cosmetics file with the agency an ingredient statement
for each of their products. Ingredient statements for new submissions
(Sec. Sec. 720.1 through 720.4) are reported on Form FDA 2512,
``Cosmetic Product Ingredient Statement,'' and on Form FDA 2512a, a
continuation form. Amendments to product formulations (Sec. Sec.
720.3, 720.4, and 720.6) also are reported on Forms FDA 2512 and FDA
2512a. When a firm discontinues the commercial distribution of a
cosmetic, FDA requests that the firm file Form FDA 2514,
``Discontinuance of Commercial Distribution of Cosmetic Product
Formulation'' (Sec. Sec. 720.3 and 720.6). If any of the information
submitted on or with these forms is confidential, the firm may submit a
request for confidentiality under Sec. 720.8.
FDA's online filing system, intended to make it easier to
participate in the VCRP, was made available industry-wide on December
1, 2005. The online filing system is available on FDA's VCRP Web site
at https://www.cfsan.fda.gov/~dms/cos-regn.html. The online filing
system contains the electronic versions of Forms FDA 2512, 2512a, and
2514, which are collectively found within the electronic version of
Form FDA 2512. The agency strongly encourages electronic filing of Form
FDA 2512 because it is faster and more convenient. A filing facility
will receive confirmation of electronic filing by e-mail. Submission of
the paper version of Forms FDA 2512, 2512a, and 2514 remains an option
as described in https://www.cfsan.fda.gov/~dms/cos-reg2.html. However,
due to the high volume of online participation, the VCRP is allocating
its limited resources primarily to electronic filings.
FDA places cosmetic product filing information in a computer data
base and uses the information for evaluation of cosmetic products
currently on the market. Because filing of cosmetic product
formulations is not mandatory, voluntary filings provide FDA with the
best information available about cosmetic product ingredients and their
frequency of use, businesses engaged in the manufacture and
distribution of cosmetics, and approximate rates of product
discontinuance and formula modifications. The information assists FDA
scientists in evaluating reports of alleged injuries and adverse
reactions from the use of cosmetics. The information also is used in
defining and planning analytical and toxicological studies pertaining
to cosmetics.
Information from the database is releasable to the public under FDA
compliance with the Freedom of Information Act. FDA shares
nonconfidential information from its files on cosmetics with consumers,
medical professionals, and industry.
FDA estimates the burden of this collection of information as
follows:
[[Page 53878]]
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Form No. Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
720.1 through FDA 141 31 4371 0.33 1,442
720.4 (new 2512\2\
submissions)
----------------------------------------------------------------------------------------------------------------
720.4 and 720.6 FDA 2512 109 7 763 0.17 130
(amendments)
----------------------------------------------------------------------------------------------------------------
720.3, 720.6 FDA 2512 55 41 2,255 0.1 226
(notices of
discontinuance
)
----------------------------------------------------------------------------------------------------------------
720.8 (requests ......... 1 1 1 1.5 1.5
for
confidentialit
y)
----------------------------------------------------------------------------------------------------------------
Total 1,800
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ The term ``Form FDA 2512'' refers to both the paper Forms FDA 2512, 2512a, and 2514 and electronic Form FDA
2512 in the electronic system known as the Voluntary Cosmetic Registration Program, which is available at
https://www.cfsan.fda.gov/~dms/cos-regn.html.
The estimated number of respondents is based on submissions
received from fiscal years 2005 to 2007. The estimated time required
for each submission is based upon information from cosmetic industry
personnel and FDA experience entering data submitted on paper Forms FDA
2512, 2512a, and 2514. The increase in total annual responses is due to
increased participation by cosmetic companies, because of a renewed
industry commitment to the program, and implementation of the online
filing system on December 1, 2005. The decrease in hours per response
is due to the ease of online filing.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: September 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21617 Filed 9-16-08; 8:45 am]
BILLING CODE 4160-01-S
