Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Cosmetic Registration Program, 23981-23982 [2014-09692]

Download as PDF Federal Register / Vol. 79, No. 82 / Tuesday, April 29, 2014 / Notices to contribute directly to the improvement of program management. Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address the following: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential nonresponse bias, the protocols for data 23981 collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Focus groups ....................................................... Customer comment cards/forms .......................... Small discussion groups ...................................... Customer satisfaction surveys ............................. 725 1,200 725 6,450 Total .............................................................. Number of responses per respondent 1 1 1 1 725 1,200 725 6,450 [FR Doc. 2014–09693 Filed 4–28–14; 8:45 am] OMB control number 0910–0027. Also include the FDA docket number found in brackets in the heading of this document. BILLING CODE 4160–01–P FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0623] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Cosmetic Registration Program Food and Drug Administration, HHS. ACTION: 1,269 300 1,269 2,129 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: April 23, 2014. Leslie Kux, Assistant Commissioner for Policy. AGENCY: 1 hour, 45 minutes ........ 15 minutes .................... 1 hour, 45 minutes ........ 20 minutes .................... Total hours 4,967 1 There Notice. The Food and Drug Administration (FDA 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. DATES: Fax written comments on the collection of information by May 29, 2014. 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 SUMMARY: sroberts on DSK5SPTVN1PROD with NOTICES Average burden per response Total annual responses VerDate Mar<15>2010 19:08 Apr 28, 2014 Jkt 232001 Voluntary Cosmetic Registration Program—21 CFR Parts 710 and 720 (OMB Control Number 0910–0027)— Extension The Federal Food, Drug, and Cosmetic Act (the FD&C Act) provides us with the authority to regulate cosmetic products in the United States. Cosmetic products that are adulterated under section 601 of the FD&C Act (21 U.S.C. 361) or misbranded under section 602 of the FD&C Act (21 U.S.C. 362) may not be distributed in interstate commerce. We have developed the VCRP to assist us in carrying out our responsibility to regulate cosmetics. In 21 CFR part 710, we request that establishments that manufacture or package cosmetic products register with us on Form FDA 2511 entitled ‘‘Registration of Cosmetic Product Establishment.’’ The term ‘‘Form FDA 2511’’ refers to both the paper and electronic versions of the form. The electronic version of Form FDA 2511 is available on our VCRP Web site at PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 https://www.fda.gov/Cosmetics/ RegistrationProgram/ OnlineRegistration/ucm090947.htm. We strongly encourage electronic registration of Form FDA 2511 because it is faster and more convenient. A registering facility will receive confirmation of electronic registration, including a registration number, by email, usually within 7 business days. The online system also allows for amendments to past submissions. Because registration of cosmetic product establishments is not mandatory, voluntary registration provides us with the best information available about the locations, business trade names, and types of activity (manufacturing or packaging) of cosmetic product establishments. We place the registration information in a computer database and use the information to generate mailing lists for distributing regulatory information and for inviting firms to participate in workshops on topics in which they may be interested. We also use the information for estimating the size of the cosmetic industry and for conducting onsite establishment inspections. Registration is permanent, although we request that respondents submit an amended Form FDA 2511 if any of the originally submitted information changes. In part 720 (21 CFR part 720), we request that firms that manufacture, pack, or distribute cosmetics file with us an ingredient statement for each of their products. Ingredient statements for new submissions (§§ 720.1 through 720.4) are reported on Form FDA 2512, E:\FR\FM\29APN1.SGM 29APN1 23982 Federal Register / Vol. 79, No. 82 / Tuesday, April 29, 2014 / Notices ‘‘Cosmetic Product Ingredient Statement,’’ and on Form FDA 2512a, a continuation form. Amendments to product formulations (§ 720.6) also are reported on Forms FDA 2512 and FDA 2512a. When a firm discontinues the commercial distribution of a cosmetic, we request that the firm file Form FDA 2514, ‘‘Notice of 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 is available on FDA’s VCRP Web site at https:// www.fda.gov/Cosmetics/ RegistrationProgram/ OnlineRegistration/ucm100241.htm. 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. We place cosmetic product filing information in a computer database and use the information for evaluation of cosmetic products currently on the market. Because filing of cosmetic product formulations is not mandatory, voluntary filings provide us 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 our scientists in evaluating reports of alleged injuries and adverse reactions from the use of cosmetics. We also use the information in defining and planning analytical and toxicological studies pertaining to cosmetics. Information from the database is releasable to the public under our compliance with the Freedom of Information Act. We share nonconfidential information from our files on cosmetics with consumers, medical professionals, and industry. In the Federal Register of February 6, 2014 (79 FR 7196), FDA published a 60day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Annual frequency per response No. of respondents Total annual responses Hours per response 21 CFR Section or Part Form no. Total hours Part 710 (registrations) ....... 720.1 through 720.4 (ingredient statements for new submissions). 720.6 (amendments) ........... 720.6 (notices of discontinuance). 720.8 (requests for confidentiality). Total ............................. FDA 2511 2 ......................... FDA 2512 3 ......................... 81 4,877 1 1 81 4,877 0.2 0.33 16 1,609 FDA 2512 ........................... FDA 2512 ........................... 1,042 1,826 1 1 1,042 1,826 0.17 0.1 177 183 ............................................. 1 1 1 2.0 2.0 ............................................. ........................ ........................ ........................ ........................ 1,987 1 There sroberts on DSK5SPTVN1PROD with NOTICES are no capital costs or operating and maintenance costs associated with this collection of information. 2 The term ‘‘Form FDA 2511’’ refers to both the paper Form FDA 2511 and electronic Form FDA 2511 in the electronic system known as the Voluntary Cosmetic Registration Program, which is available at https://www.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/ ucm090947.htm. 3 The term ‘‘Form FDA 2512’’ refers to 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.fda.gov/Cosmetics/RegistrationProgram/ OnlineRegistration/ucm100241.htm. We base our estimate of the total annual responses on paper and electronic submissions received during calendar years 2011, 2012 and 2013. We base our estimate of the hours per response upon information from cosmetic industry personnel and our experience entering data submitted on paper Forms 2511, 2512, 2512a, and 2514 into the electronic system. We estimate that, annually, 81 establishments that manufacture or package cosmetic products will each submit 1 registration on Form FDA 2511, for a total of 81 annual responses. Each submission is estimated to take 0.2 hour per response for a total of 16.2 hours, rounded to 16. We estimate that, annually, firms that manufacture, pack, or distribute cosmetics will file 4,877 ingredient statements for new submissions on Forms FDA 2512 and FDA 2512a. Each submission is estimated to take 0.33 hour per response VerDate Mar<15>2010 16:56 Apr 28, 2014 Jkt 232001 for a total of 1,609.41 hours, rounded to 1,609. We estimate that, annually, firms that manufacture, pack, or distribute cosmetics will file 1,042 amendments to product formulations on Forms FDA 2512 and FDA 2512a. Each submission is estimated to take 0.17 hour per response for a total of 177.14 hours, rounded to 177. We estimate that, annually, firms that manufacture, pack, or distribute cosmetics will file 1,826 notices of discontinuance on Form FDA 2514. Each submission is estimated to take 0.1 hour per response for a total of 182.6 hours, rounded to 183. We estimate that, annually, one firm will file one request for confidentiality. Each such request is estimated to take 2 hours to prepare for a total of 2.0 hours. Thus, the total estimated hour burden for this information collection is 1,987 hours. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 Dated: April 21, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–09692 Filed 4–28–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Pediatric Clinical Investigator Training Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration’s (FDA) Office of Pediatric Therapeutics (OPT) and the Center for Drug Evaluation and Research are announcing a 1-day public SUMMARY: E:\FR\FM\29APN1.SGM 29APN1

Agencies

[Federal Register Volume 79, Number 82 (Tuesday, April 29, 2014)]
[Notices]
[Pages 23981-23982]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09692]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0623]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Voluntary Cosmetic
Registration Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA 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.

DATES: Fax written comments on the collection of information by May 29,
2014.

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 0910-0027.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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.

Voluntary Cosmetic Registration Program--21 CFR Parts 710 and 720 (OMB
Control Number 0910-0027)--Extension

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) provides us
with the authority to regulate cosmetic products in the United States.
Cosmetic products that are adulterated under section 601 of the FD&C
Act (21 U.S.C. 361) or misbranded under section 602 of the FD&C Act (21
U.S.C. 362) may not be distributed in interstate commerce. We have
developed the VCRP to assist us in carrying out our responsibility to
regulate cosmetics.
In 21 CFR part 710, we request that establishments that manufacture
or package cosmetic products register with us on Form FDA 2511 entitled
``Registration of Cosmetic Product Establishment.'' The term ``Form FDA
2511'' refers to both the paper and electronic versions of the form.
The electronic version of Form FDA 2511 is available on our VCRP Web
site at https://www.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/ucm090947.htm. We strongly encourage electronic
registration of Form FDA 2511 because it is faster and more convenient.
A registering facility will receive confirmation of electronic
registration, including a registration number, by email, usually within
7 business days. The online system also allows for amendments to past
submissions.
Because registration of cosmetic product establishments is not
mandatory, voluntary registration provides us with the best information
available about the locations, business trade names, and types of
activity (manufacturing or packaging) of cosmetic product
establishments. We place the registration information in a computer
database and use the information to generate mailing lists for
distributing regulatory information and for inviting firms to
participate in workshops on topics in which they may be interested. We
also use the information for estimating the size of the cosmetic
industry and for conducting onsite establishment inspections.
Registration is permanent, although we request that respondents submit
an amended Form FDA 2511 if any of the originally submitted information
changes.
In part 720 (21 CFR part 720), we request that firms that
manufacture, pack, or distribute cosmetics file with us 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,

[[Page 23982]]

``Cosmetic Product Ingredient Statement,'' and on Form FDA 2512a, a
continuation form. Amendments to product formulations (Sec. 720.6)
also are reported on Forms FDA 2512 and FDA 2512a. When a firm
discontinues the commercial distribution of a cosmetic, we request that
the firm file Form FDA 2514, ``Notice of 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 is available on FDA's VCRP Web site at
https://www.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/ucm100241.htm. 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.
We place cosmetic product filing information in a computer database
and use the information for evaluation of cosmetic products currently
on the market. Because filing of cosmetic product formulations is not
mandatory, voluntary filings provide us 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 our scientists in evaluating
reports of alleged injuries and adverse reactions from the use of
cosmetics. We also use the information in defining and planning
analytical and toxicological studies pertaining to cosmetics.
Information from the database is releasable to the public under our
compliance with the Freedom of Information Act. We share
nonconfidential information from our files on cosmetics with consumers,
medical professionals, and industry.
In the Federal Register of February 6, 2014 (79 FR 7196), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section or Part Form no. No. of frequency per Total annual Hours per Total hours
respondents response responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 710 (registrations).................. FDA 2511 \2\................ 81 1 81 0.2 16
720.1 through 720.4 (ingredient statements FDA 2512 \3\................ 4,877 1 4,877 0.33 1,609
for new submissions).
720.6 (amendments)........................ FDA 2512.................... 1,042 1 1,042 0.17 177
720.6 (notices of discontinuance)......... FDA 2512.................... 1,826 1 1,826 0.1 183
720.8 (requests for confidentiality)...... ............................ 1 1 1 2.0 2.0
Total................................. ............................ .............. .............. .............. .............. 1,987
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The term ``Form FDA 2511'' refers to both the paper Form FDA 2511 and electronic Form FDA 2511 in the electronic system known as the Voluntary
Cosmetic Registration Program, which is available at https://www.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/ucm090947.htm.
\3\ The term ``Form FDA 2512'' refers to 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.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/ucm100241.htm.

We base our estimate of the total annual responses on paper and
electronic submissions received during calendar years 2011, 2012 and
2013. We base our estimate of the hours per response upon information
from cosmetic industry personnel and our experience entering data
submitted on paper Forms 2511, 2512, 2512a, and 2514 into the
electronic system.
We estimate that, annually, 81 establishments that manufacture or
package cosmetic products will each submit 1 registration on Form FDA
2511, for a total of 81 annual responses. Each submission is estimated
to take 0.2 hour per response for a total of 16.2 hours, rounded to 16.
We estimate that, annually, firms that manufacture, pack, or distribute
cosmetics will file 4,877 ingredient statements for new submissions on
Forms FDA 2512 and FDA 2512a. Each submission is estimated to take 0.33
hour per response for a total of 1,609.41 hours, rounded to 1,609. We
estimate that, annually, firms that manufacture, pack, or distribute
cosmetics will file 1,042 amendments to product formulations on Forms
FDA 2512 and FDA 2512a. Each submission is estimated to take 0.17 hour
per response for a total of 177.14 hours, rounded to 177. We estimate
that, annually, firms that manufacture, pack, or distribute cosmetics
will file 1,826 notices of discontinuance on Form FDA 2514. Each
submission is estimated to take 0.1 hour per response for a total of
182.6 hours, rounded to 183. We estimate that, annually, one firm will
file one request for confidentiality. Each such request is estimated to
take 2 hours to prepare for a total of 2.0 hours. Thus, the total
estimated hour burden for this information collection is 1,987 hours.

Dated: April 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09692 Filed 4-28-14; 8:45 am]
BILLING CODE 4160-01-P

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