Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Cosmetic Registration Program, 39795-39797 [2017-17701]
Download as PDF
Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices
for labeling are included in the estimate
for § 71.1. Also, because labeling
requirements under parts 172, 173, 179,
and 180 for particular food additives
involve information required as part of
the FAP safety review process under
§ 171.1, the burden hours for labeling
are included in the estimate for § 171.1.
Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–17703 Filed 8–21–17; 8:45 am]
BILLING CODE 4164–01–P
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.
The Food and Drug
Administration (FDA, 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).
SUMMARY:
Fax written comments on the
collection of information by September
21, 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 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.
DATES:
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, 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.
sradovich on DSK3GMQ082PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
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Jkt 241001
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 Voluntary Cosmetic
Registration Program (VCRP) to assist us
in carrying out our responsibility to
regulate cosmetics.
FDA is revising forms for the VCRP
(Forms FDA 2511, 2512, 2512a, and
2514) currently approved under OMB
control number 0910–0027, ‘‘Voluntary
Cosmetic Registration Program,’’ for the
following reasons: (1) Modernizing the
forms; (2) Making it easier for filers who
complete the forms; and (3) reducing the
time it will take FDA to review each
submission. In addition, Form FDA
2514 will be eliminated as it duplicates
information that is currently located on
Form FDA 2512. FDA requests PRA
approval for the proposed changes to
these forms, and for the elimination of
Form FDA 2514.
Participation in the VCRP is voluntary
under provisions found in sections parts
710 and 720 (21 CFR parts 710 and 720).
Participants have the option of
submitting information via paper forms
or via the online interface. The term
‘‘form’’ refers to both the paper form and
the online system.
Currently, in part 710, we request that
establishments that manufacture or
package cosmetic products voluntarily
register with us using Form FDA 2511
entitled ‘‘Registration of Cosmetic
Product Establishment.’’ The online
version of Form FDA 2511 is available
on our VCRP Web site at https://
www.fda.gov/Cosmetics/Registration
Program/default.htm. We strongly
encourage online registration with Form
FDA 2511 because it is faster and more
efficient for the filer and the Agency. A
registering facility will receive
confirmation of online registration,
including a registration number by
email. The online system also allows for
amendments to past submissions.
Because registration of cosmetic
product establishments is not
mandatory, voluntary registration
provides FDA 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
PO 00000
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Fmt 4703
Sfmt 4703
39795
computer database and use the
information to generate lists for
distributing regulatory information and
for inviting firms to participate in
workshops on topics in which they may
be interested. Registration is permanent,
although we request that respondents
submit an amended Form FDA 2511 if
any of the originally submitted
information changes.
FDA’s proposed changes to the forms
through the use of an electronic
submission system have been designed
to make it easier for participants to
provide information to FDA about their
products. The system also assists
participants, through interactive
question and response scenarios, to
identify submissions that will be
ineligible to be accepted in VCRP
because they do not meet parts 710 and
720 requirements. The electronic
submission system is expected to reduce
burden currently associated with the
manual identification process for filers
and FDA. The rejection rate for
ineligible submissions when using the
current forms is high: 51 percent for
new accounts, 43 percent for Form FDA
2511 registrations, and 7 percent for
Form FDA 2512 filings (2010–2016).
The revised forms include the
addition of links between Forms FDA
2511 and 2512, clarification of what
information should be entered onto the
forms, additional self-identifying fields,
removal of certain duplicative fields,
and the deletion of Form FDA 2514.
These changes are needed because both
VCRP voluntary filer participation and
FDA resources required to administer
VCRP have increased significantly since
2014 (i.e., increases in new accounts
(156 percent), Form FDA 2511
registrations (405 percent), Form FDA
2512 filings (67 percent), and FDA
review hours (59 percent) in 2016.)
FDA’s current process confirms that
each submission meets the requirements
established in parts 710 and 720 by
using a manual process for both filers
and FDA reviewers that may result in a
long waiting period where filers must
wait and respond to questions generated
by FDA, which may result in a high
rejection rate. FDA projects a significant
reduction in rejection rates when using
the revised forms. Examples of possible
burden savings for participants and FDA
include:
(1) Form FDA 2511 asks filers if they
are a manufacturer or packer; however,
in the past, distributors and retailers
have checked these boxes in error when
neither applies to them because there
are no distributor or retailer checkboxes
on Form FDA 2511. Retailers have also
filed Form FDA 2512 in error even
though only manufacturers, packers,
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Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices
and distributors are permitted to do so.
To correct these issues, FDA revised
Form FDA 2511 by updating the field
that allows filers to indicate the ‘‘TYPE
OF ESTABLISHMENT:
MANUFACTURER/PACKER/OTHER
(Distributor or Retailer)’’ and updating
the field on Form FDA 2512 allowing
the filer to indicate ‘‘WHO IS FILING
THIS STATEMENT: MANUFACTURER/
PACKER/DISTRIBUTOR/OTHER
(Retailer).’’
(2) FDA revised Form FDA 2511 and
added questions asking, ‘‘Are you the
owner or operator of this facility?’’ and
‘‘Is the address on this form the location
of a cosmetic manufacturing and/or
packing facility?’’
(3) FDA also revised Form FDA 2512
and added questions asking, ‘‘Is this
product currently commercially
distributed (annual sales exceed $1,000)
in the United States?’’, ‘‘PRODUCT
WEBSITE’’, and ‘‘Attach images of the
front and back product labels to this
form’’ to ensure that only cosmetics in
commercial distribution in the United
States are filed in the VCRP.
(4) FDA linked Forms FDA 2511 and
2512 to reduce burden to filers who
create multiple copies of Form FDA
2512 that share the same establishment
addresses.
(5) FDA clarified the information that
should be included on the forms by
attaching simplified instructions and a
link to VCRP online on Forms FDA
2511, 2512, and 2512a and adding titles
and locations of various fields
throughout Forms FDA 2511, 2512, and
2512a. We also added self-identifying
information such as phone number,
email, and alternative authorized
individual fields to Forms FDA 2511
and 2512 to facilitate communication
with the filers.
(6) We also removed fields that have
no modern use or request redundant
information in multiple locations.
(7) We removed Form FDA 2514 in its
entirety due to redundancy. (As noted,
filers may notify FDA that they are
discontinuing a cosmetic product
formulation on Form FDA 2512).
FDA’s online filing system is available
on FDA’s VCRP Web site at https://
www.fda.gov/Cosmetics/Registration
Program/default.htm. The online filing
system contains the online versions of
Forms FDA 2511, 2512, and 2512a.
We place cosmetic product filing
information in a computer database and
use the information when FDA receives
inquiries about cosmetics marketed in
the United States. Because filing of
cosmetic product formulations is not
mandatory, voluntary filings with FDA
provide us with the best information
available about cosmetic products,
ingredients, 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
adverse events submitted via MedWatch
and Field Operators (FACTS). We also
use the information in identifying future
research projects, to evaluate the levels
and safety of certain ingredients in
cosmetics.
Links to explanations of the revisions
to Forms FDA 2511, 2512, and 2512a
and instructions are available at https://
www.fda.gov/Cosmetics/Registration
Program/default.htm and entitled
‘‘Voluntary Cosmetic Registration
Program.’’
In the Federal Register of May 31,
2017 (82 FR 24977), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. Two
comments were received. One comment
appeared to be a submission under 21
CFR 10.35 and 10.40(b)(3) and therefore
is not addressed here. The second
comment offered suggestions that FDA
might consider regarding the content
and format of reporting elements, but
made no suggestion for FDA to revise its
burden estimate. Accordingly, while the
Agency is currently reviewing these
suggestions to determine whether our
current IT system may be upgraded to
the benefit of respondents, we retain the
burden estimate from our 60-day notice.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses
per
respondent
Average
burden per
response
Total annual
responses
21 CFR Section or part
Form No.
Total hours
Part 710 (registrations) ..................................
720.1 through 720.4 (new submissions) .......
720.6 (amendments) ......................................
720.6 (notices of discontinuance) ..................
720.8 (requests for confidentiality) ................
FDA 2511 2 ....
FDA 2512 3 ....
FDA 2512 ......
FDA 2512 ......
........................
934
7,108
4,049
95
1
1
1
1
1
1
934
7,108
4,049
95
1
0.20 (12 minutes) ....
0.33 (20 minutes) ....
0.17 (10 minutes) ....
0.10 (6 minutes) ......
2 ..............................
187
2,346
688
10
2
Total ........................................................
........................
....................
......................
....................
.................................
3,233
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
term ‘‘Form FDA 2511’’ refers to both the paper Form FDA 2511 and online Form FDA 2511 in the online system known as the VCRP,
which is available at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm.
3 The term ‘‘Form FDA 2512’’ refers to the paper Forms FDA 2512, and 2512a and online Form FDA 2512 in the online system known as the
VCRP, which is available at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm.
sradovich on DSK3GMQ082PROD with NOTICES
2 The
We base our estimate of the total
annual responses on paper and online
submissions received during calendar
year 2016. We base our estimate of the
hours per response upon information
from cosmetic industry personnel and
FDA experience entering data submitted
on paper Forms FDA 2511, 2512, and
2512a into the online system.
We estimate that, annually, 934
establishments that manufacture or
package cosmetic products will each
VerDate Sep<11>2014
18:00 Aug 21, 2017
Jkt 241001
submit 1 registration on Form FDA
2511, for a total of 934 annual
responses. Each submission is estimated
to take 0.20 hour per response for a total
of 186.8 hours, rounded to 187. The
number of Form FDA 2511 submissions
has increased 405 percent compared to
2014 and we have no indication that
this submission rate will stop
increasing. We estimate that, annually,
firms that manufacture, pack, or
distribute cosmetics will file 7,108
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Fmt 4703
Sfmt 4703
ingredient statements for new or
amended submissions on Forms FDA
2512 and FDA 2512a. Each submission
is estimated to take 0.33 hour per
response for a total of 2345.64 hours,
rounded to 2,346. We estimate the
number of Form FDA 2512 submissions
to increase 67 percent compared to 2014
and we have no indication that this
submission rate will stop increasing. We
estimate that, annually, firms that
manufacture, pack, or distribute
E:\FR\FM\22AUN1.SGM
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Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices
183(a)(1) of the Medicare Improvements
for Patients and Providers Act of 2008
(MIPPA) (Pub. L. 110–275), requires the
Secretary to identify and have in effect
a contract with a consensus-based entity
(CBE) to perform multiple duties
described in subsection (b) that are
designed to help improve performance
measurement. The duties described in
subsection (b) originally included a
priority setting process, measure
endorsement, measure maintenance,
electronic health record promotion, and
the preparation of an annual Report to
Congress and the Secretary. Section
3003(b) of the Patient Protection and
Affordable Care Act (Pub. L. 111–148) as
amended by the Health Care and
Education Reconciliation Act (Pub. L.
Dated: August 17, 2017.
111–152) (collectively, the Affordable
Leslie Kux,
Care Act) expanded the duties of the
Associate Commissioner for Policy.
CBE to require the CBE to review and,
[FR Doc. 2017–17701 Filed 8–21–17; 8:45 am]
as appropriate, endorse the episode
BILLING CODE 4164–01–P
grouper developed by the Secretary
under the Physician Feedback Program.
Section 3014(a)(1) of the Affordable
DEPARTMENT OF HEALTH AND
Care Act further expanded the duties to
HUMAN SERVICES
require the CBE to convene multistakeholder groups to provide input on
[CMS–3340–N]
the selection of quality and efficiency
measures and national priorities for
Secretarial Review and Publication of
improvement in population health and
the National Quality Forum Report of
in the delivery of health care services
2016 Activities to Congress and the
for consideration under the national
Secretary of the Department of Health
strategy, and to transmit such input to
and Human Services
the Secretary. Section 3014(a)(2) of the
AGENCY: Office of the Secretary of
Affordable Care Act expanded the
Health and Human Services, HHS.
requirements for the annual report that
ACTION: Notice.
must be submitted under section
1890(b)(5)(A) of the Act.
SUMMARY: This notice acknowledges that
To meet the requirements of section
in accordance with section 1890(b)(5)(B) 1890(a) of the Act, in January of 2009,
of the Social Security Act (the Act) the
the Department of Health and Human
Secretary of the Department of Health
Services (HHS) awarded a competitive
and Human Services (the Secretary) has contract to the National Quality Forum
received and reviewed the National
(NQF). A second, multi-year contract
Quality Forum (NQF) Report of 2016
was awarded to NQF after an open
Activities to Congress and the Secretary competition in 2012. This contract
of the Department of Health and Human includes the following duties:
Services submitted by the consensusPriority Setting Process: Formulation
based entity with whom the Secretary
of a National Strategy and Priorities for
has a contract under section 1890(a) of
Health Care Performance Measurement.
the Act. The purpose of this Federal
The CBE is required to synthesize
Register notice is to publish the report,
evidence and convene key stakeholders
together with the Secretary’s comments
to make recommendations on an
on such report.
integrated national strategy and
priorities for health care performance
FOR FURTHER INFORMATION CONTACT:
measurement in all applicable settings.
Sophia Chan, (410) 786–5050.
In doing so, the CBE is to give priority
I. Background
to measures that: (1) Address the health
The Secretary of the Department of
care provided to patients with
Health and Human Services (the
prevalent, high-cost chronic diseases;
Secretary) has long recognized that a
(2) have the greatest potential for
high functioning health care system that improving quality, efficiency and
provides higher quality care requires
patient-centeredness of health care; and
accurate, valid, and reliable
(3) may be implemented rapidly due to
existing evidence, standards of care, or
measurement of quality and efficiency.
other reasons. Additionally, the CBE
Section 1890(a) of the Social Security
must take into account measures that:
Act (the Act), as added by section
sradovich on DSK3GMQ082PROD with NOTICES
cosmetics will file 4,049 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 688.33 hours,
rounded to 688. We estimate that,
annually, firms that manufacture, pack,
or distribute cosmetics will file 95
notices of discontinuance on Form FDA
2512. Each submission is estimated to
take 0.10 hour per response for a total
of 9.5 hours, rounded to 10. 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 hours. Thus, the
total estimated hour burden for this
information collection is 3,233 hours.
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18:00 Aug 21, 2017
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Fmt 4703
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39797
(1) May assist consumers and patients in
making informed health care decisions;
(2) address health disparities across
groups and areas; and (3) address the
continuum of care a patient receives,
including across multiple providers,
practitioners and settings.
Endorsement of Measures. The CBE is
required to provide for the endorsement
of standardized health care performance
measures. This process must consider
whether measures are evidence-based,
reliable, valid, verifiable, relevant to
enhanced health outcomes, actionable at
the caregiver level, feasible to collect
and report, responsive to variations in
patient characteristics such as health
status, language capabilities, race or
ethnicity, and income level and
consistent across types of health care
providers, including hospitals and
physicians.
Maintenance of CBE Endorsed
Measures. The CBE is required to
establish and implement a process to
ensure that endorsed measures are
updated (or retired if obsolete) as new
evidence is developed.
Review and Endorsement of an
Episode Grouper Under the Physician
Feedback Program. ‘‘Episode-based’’
performance measurement is an
approach to better understanding the
utilization and costs associated with a
certain condition by grouping together
all the care related to that condition.
‘‘Episode groupers’’ are software tools
that combine data to assess such
condition-specific utilization and costs
over a defined period of time. The CBE
is required to provide for the review,
and as appropriate, endorsement of an
episode grouper as developed by the
Secretary on an expedited basis.
Convening Multi-Stakeholder Groups.
The CBE must convene multistakeholder groups to provide input on:
(1) The selection of certain categories of
quality and efficiency measures, from
among such measures that have been
endorsed by the entity; and such
measures that have not been considered
for endorsement by such entity but are
used or proposed to be used by the
Secretary for the collection or reporting
of quality and efficiency measures; and
(2) national priorities for improvement
in population health and in the delivery
of health care services for consideration
under the national strategy. The CBE
provides input on measures for use in
certain specific Medicare programs, for
use in programs that report performance
information to the public, and for use in
health care programs that are not
included under the Act. The multistakeholder groups provide input on
quality and efficiency measures for use
in certain federal programs including
E:\FR\FM\22AUN1.SGM
22AUN1
Agencies
[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Pages 39795-39797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17701]
-----------------------------------------------------------------------
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, 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 21, 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 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: 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,
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 Voluntary Cosmetic Registration Program (VCRP) to assist
us in carrying out our responsibility to regulate cosmetics.
FDA is revising forms for the VCRP (Forms FDA 2511, 2512, 2512a,
and 2514) currently approved under OMB control number 0910-0027,
``Voluntary Cosmetic Registration Program,'' for the following reasons:
(1) Modernizing the forms; (2) Making it easier for filers who complete
the forms; and (3) reducing the time it will take FDA to review each
submission. In addition, Form FDA 2514 will be eliminated as it
duplicates information that is currently located on Form FDA 2512. FDA
requests PRA approval for the proposed changes to these forms, and for
the elimination of Form FDA 2514.
Participation in the VCRP is voluntary under provisions found in
sections parts 710 and 720 (21 CFR parts 710 and 720). Participants
have the option of submitting information via paper forms or via the
online interface. The term ``form'' refers to both the paper form and
the online system.
Currently, in part 710, we request that establishments that
manufacture or package cosmetic products voluntarily register with us
using Form FDA 2511 entitled ``Registration of Cosmetic Product
Establishment.'' The online version of Form FDA 2511 is available on
our VCRP Web site at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm. We strongly encourage online registration with Form FDA
2511 because it is faster and more efficient for the filer and the
Agency. A registering facility will receive confirmation of online
registration, including a registration number by email. The online
system also allows for amendments to past submissions.
Because registration of cosmetic product establishments is not
mandatory, voluntary registration provides FDA 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 lists for distributing
regulatory information and for inviting firms to participate in
workshops on topics in which they may be interested. Registration is
permanent, although we request that respondents submit an amended Form
FDA 2511 if any of the originally submitted information changes.
FDA's proposed changes to the forms through the use of an
electronic submission system have been designed to make it easier for
participants to provide information to FDA about their products. The
system also assists participants, through interactive question and
response scenarios, to identify submissions that will be ineligible to
be accepted in VCRP because they do not meet parts 710 and 720
requirements. The electronic submission system is expected to reduce
burden currently associated with the manual identification process for
filers and FDA. The rejection rate for ineligible submissions when
using the current forms is high: 51 percent for new accounts, 43
percent for Form FDA 2511 registrations, and 7 percent for Form FDA
2512 filings (2010-2016).
The revised forms include the addition of links between Forms FDA
2511 and 2512, clarification of what information should be entered onto
the forms, additional self-identifying fields, removal of certain
duplicative fields, and the deletion of Form FDA 2514. These changes
are needed because both VCRP voluntary filer participation and FDA
resources required to administer VCRP have increased significantly
since 2014 (i.e., increases in new accounts (156 percent), Form FDA
2511 registrations (405 percent), Form FDA 2512 filings (67 percent),
and FDA review hours (59 percent) in 2016.)
FDA's current process confirms that each submission meets the
requirements established in parts 710 and 720 by using a manual process
for both filers and FDA reviewers that may result in a long waiting
period where filers must wait and respond to questions generated by
FDA, which may result in a high rejection rate. FDA projects a
significant reduction in rejection rates when using the revised forms.
Examples of possible burden savings for participants and FDA include:
(1) Form FDA 2511 asks filers if they are a manufacturer or packer;
however, in the past, distributors and retailers have checked these
boxes in error when neither applies to them because there are no
distributor or retailer checkboxes on Form FDA 2511. Retailers have
also filed Form FDA 2512 in error even though only manufacturers,
packers,
[[Page 39796]]
and distributors are permitted to do so. To correct these issues, FDA
revised Form FDA 2511 by updating the field that allows filers to
indicate the ``TYPE OF ESTABLISHMENT: MANUFACTURER/PACKER/OTHER
(Distributor or Retailer)'' and updating the field on Form FDA 2512
allowing the filer to indicate ``WHO IS FILING THIS STATEMENT:
MANUFACTURER/PACKER/DISTRIBUTOR/OTHER (Retailer).''
(2) FDA revised Form FDA 2511 and added questions asking, ``Are you
the owner or operator of this facility?'' and ``Is the address on this
form the location of a cosmetic manufacturing and/or packing
facility?''
(3) FDA also revised Form FDA 2512 and added questions asking, ``Is
this product currently commercially distributed (annual sales exceed
$1,000) in the United States?'', ``PRODUCT WEBSITE'', and ``Attach
images of the front and back product labels to this form'' to ensure
that only cosmetics in commercial distribution in the United States are
filed in the VCRP.
(4) FDA linked Forms FDA 2511 and 2512 to reduce burden to filers
who create multiple copies of Form FDA 2512 that share the same
establishment addresses.
(5) FDA clarified the information that should be included on the
forms by attaching simplified instructions and a link to VCRP online on
Forms FDA 2511, 2512, and 2512a and adding titles and locations of
various fields throughout Forms FDA 2511, 2512, and 2512a. We also
added self-identifying information such as phone number, email, and
alternative authorized individual fields to Forms FDA 2511 and 2512 to
facilitate communication with the filers.
(6) We also removed fields that have no modern use or request
redundant information in multiple locations.
(7) We removed Form FDA 2514 in its entirety due to redundancy. (As
noted, filers may notify FDA that they are discontinuing a cosmetic
product formulation on Form FDA 2512).
FDA's online filing system is available on FDA's VCRP Web site at
https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm. The
online filing system contains the online versions of Forms FDA 2511,
2512, and 2512a.
We place cosmetic product filing information in a computer database
and use the information when FDA receives inquiries about cosmetics
marketed in the United States. Because filing of cosmetic product
formulations is not mandatory, voluntary filings with FDA provide us
with the best information available about cosmetic products,
ingredients, 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 adverse events submitted via
MedWatch and Field Operators (FACTS). We also use the information in
identifying future research projects, to evaluate the levels and safety
of certain ingredients in cosmetics.
Links to explanations of the revisions to Forms FDA 2511, 2512, and
2512a and instructions are available at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm and entitled ``Voluntary Cosmetic
Registration Program.''
In the Federal Register of May 31, 2017 (82 FR 24977), we published
a 60-day notice requesting public comment on the proposed extension of
this collection of information. Two comments were received. One comment
appeared to be a submission under 21 CFR 10.35 and 10.40(b)(3) and
therefore is not addressed here. The second comment offered suggestions
that FDA might consider regarding the content and format of reporting
elements, but made no suggestion for FDA to revise its burden estimate.
Accordingly, while the Agency is currently reviewing these suggestions
to determine whether our current IT system may be upgraded to the
benefit of respondents, we retain the burden estimate from our 60-day
notice.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Number of responses Total Total
21 CFR Section or part Form No. respondents per annual Average burden per response hours
respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 710 (registrations)............. FDA 2511 \2\.............. 934 1 934 0.20 (12 minutes)................ 187
720.1 through 720.4 (new submissions) FDA 2512 \3\.............. 7,108 1 7,108 0.33 (20 minutes)................ 2,346
720.6 (amendments)................... FDA 2512.................. 4,049 1 4,049 0.17 (10 minutes)................ 688
720.6 (notices of discontinuance).... FDA 2512.................. 95 1 95 0.10 (6 minutes)................. 10
720.8 (requests for confidentiality). .......................... 1 1 1 2................................ 2
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Total............................ .......................... ........... ............ ........... ................................. 3,233
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\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 online Form FDA 2511 in the online system known as the VCRP, which is
available at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm.
\3\ The term ``Form FDA 2512'' refers to the paper Forms FDA 2512, and 2512a and online Form FDA 2512 in the online system known as the VCRP, which is
available at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm.
We base our estimate of the total annual responses on paper and
online submissions received during calendar year 2016. We base our
estimate of the hours per response upon information from cosmetic
industry personnel and FDA experience entering data submitted on paper
Forms FDA 2511, 2512, and 2512a into the online system.
We estimate that, annually, 934 establishments that manufacture or
package cosmetic products will each submit 1 registration on Form FDA
2511, for a total of 934 annual responses. Each submission is estimated
to take 0.20 hour per response for a total of 186.8 hours, rounded to
187. The number of Form FDA 2511 submissions has increased 405 percent
compared to 2014 and we have no indication that this submission rate
will stop increasing. We estimate that, annually, firms that
manufacture, pack, or distribute cosmetics will file 7,108 ingredient
statements for new or amended submissions on Forms FDA 2512 and FDA
2512a. Each submission is estimated to take 0.33 hour per response for
a total of 2345.64 hours, rounded to 2,346. We estimate the number of
Form FDA 2512 submissions to increase 67 percent compared to 2014 and
we have no indication that this submission rate will stop increasing.
We estimate that, annually, firms that manufacture, pack, or distribute
[[Page 39797]]
cosmetics will file 4,049 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 688.33 hours, rounded to 688. We estimate
that, annually, firms that manufacture, pack, or distribute cosmetics
will file 95 notices of discontinuance on Form FDA 2512. Each
submission is estimated to take 0.10 hour per response for a total of
9.5 hours, rounded to 10. 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 hours. Thus, the total
estimated hour burden for this information collection is 3,233 hours.
Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17701 Filed 8-21-17; 8:45 am]
BILLING CODE 4164-01-P