Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Cosmetic Registration Program, 24977-24980 [2017-11188]
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Federal Register / Vol. 82, No. 103 / Wednesday, May 31, 2017 / Notices
Estimated Total Annual Burden
Hours: 54,934.99.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW.,
Washington, DC 20202; Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017–11234 Filed 5–30–17; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0623]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Voluntary
Cosmetic Registration Program
AGENCY:
Food and Drug Administration,
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HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
SUMMARY:
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1995 (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
invites comments on the collection of
information associated with our
Voluntary Cosmetic Registration
Program (VCRP).
DATES: Submit either electronic or
written comments on the collection of
information by July 31, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 31, 2017.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 31, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov/. Follow
the instructions for submitting
comments. Comments submitted
electronically, including attachments, to
https://www.regulations.gov/ will be
posted to the docket unchanged.
Because your comment will be made
public, you are solely responsible for
ensuring that your comment does not
include any confidential information
that you or a third party may not wish
to be posted, such as medical
information, your or anyone else’s
Social Security number, or confidential
business information, such as a
manufacturing process. Please note that
if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov/.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
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24977
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2010–N–0623 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Voluntary Cosmetic Registration
Program.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://
www.regulations.gov/ or at the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov/. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov/ and insert the
docket number, found in brackets in the
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Federal Register / Vol. 82, No. 103 / Wednesday, May 31, 2017 / Notices
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
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: 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.
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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
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distributed in interstate commerce. We
have developed the 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) decreasing burden to 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 term
‘‘Form FDA 2511’’ refers to both the
paper and online versions of the form.
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 of
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 mailing 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.
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Currently, under part 720, FDA
requests firms that manufacture, pack,
or distribute cosmetics to file with the
Agency an ingredient statement for each
of their products. Filing of cosmetic
product ingredient statements is
voluntary. Ingredient statements for new
submissions are reported on Form FDA
2512, ‘‘Cosmetic Product Ingredient
Statement,’’ and on Form FDA 2512a, a
continuation form. Amendments to
product formulations 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, ‘‘Notice of Discontinuance of
Commercial Distribution of Cosmetic
Product Formulation’’; however, filers
may also notify FDA that they have
discontinued a cosmetic product
formulation by submitting an amended
Form FDA 2512, which would obviate
the need for Form FDA 2514. If any of
the information submitted on these
forms is confidential, the firm may
submit a request for confidentiality of a
cosmetic ingredient.
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. They also assist 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
through the use of a manual process for
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both filers and FDA reviewers that can
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,
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,
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
fields such as phone number, email, and
alternative authorized individual to
Form 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://
24979
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.’’
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section or Part
Form No.
Part 710 (registrations) ..........................
720.1 through 720.4 (new submissions)
720.6 (amendments) .............................
720.6 (notices of discontinuance) .........
720.8 (requests for confidentiality) ........
FDA
FDA
FDA
FDA
Number of
respondents
2511 2
2512 3
2512
2512
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
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 ................................................
934
7,108
4,049
95
1
........................
........................
....................................
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.
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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
submit 1 registration on Form FDA
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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
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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
cosmetics will file 4,049 amendments to
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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: May 25, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–11188 Filed 5–30–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration, Department of Health
and Human Services.
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the program in
general, contact the Acting Clerk of the
Court, Lisa L. Reyes, United States Court
of Federal Claims, 717 Madison Place
NW., Washington, DC 20005, (202) 357–
6400. For information on HRSA’s role in
the program, contact the Director,
National Vaccine Injury Compensation
Program, 5600 Fishers Lane, Room
08N146B, Rockville, MD 20857; (301)
443–6593, or visit our Web site at:
https://www.hrsa.gov/vaccine
compensation/.
SUPPLEMENTARY INFORMATION: The
program provides a system of no-fault
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SUMMARY:
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compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of HHS, who is named as the
respondent in each proceeding. The
Secretary has delegated this
responsibility under the program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
manifested outside the time periods
specified in the Table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111 the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
April 1, 2017, through April 30, 2017.
This list provides the name of the
petitioner, city and state of vaccination
(if unknown then city and state of
person or attorney filing claim), and
case number. In cases where the Court
has redacted the name of the petitioner
and/or the case number, the list reflects
such redaction.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
submit relevant, written information’’
relating to the following:
1. The existence of evidence ‘‘that
there is not a preponderance of the
evidence that the illness, disability,
injury, condition, or death described in
the petition is due to factors unrelated
to the administration of the vaccine
described in the petition,’’ and
2. Any allegation in a petition that the
petitioner either:
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a. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition not set forth in the
Vaccine Injury Table but which was
caused by’’ one of the vaccines referred
to in the Table, or
b. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition set forth in the
Vaccine Injury Table the first symptom
or manifestation of the onset or
significant aggravation of which did not
occur within the time period set forth in
the Table but which was caused by a
vaccine’’ referred to in the Table.
In accordance with Section
2112(b)(2), all interested persons may
submit written information relevant to
the issues described above in the case of
the petitions listed below. Any person
choosing to do so should file an original
and three (3) copies of the information
with the Clerk of the U.S. Court of
Federal Claims at the address listed
above (under the heading FOR FURTHER
INFORMATION CONTACT), with a copy to
HRSA addressed to Director, Division of
Injury Compensation Programs,
Healthcare Systems Bureau, 5600
Fishers Lane, 08N146B, Rockville, MD
20857. The Court’s caption (Petitioner’s
Name v. Secretary of HHS) and the
docket number assigned to the petition
should be used as the caption for the
written submission. Chapter 35 of title
44, United States Code, related to
paperwork reduction, does not apply to
information required for purposes of
carrying out the program.
Dated: May 19, 2017.
George Sigounas,
Administrator.
List of Petitions Filed
1. Anissa E. Rogers on behalf of L. C.,
Fullerton, California, Court of
Federal Claims No: 17–0470V.
2. John Solak, Binghamton, New York,
Court of Federal Claims No: 17–
0472V.
3. Dolores Justice, Pittsburgh,
Pennsylvania, Court of Federal
Claims No: 17–0476V.
4. Ruben Abeyta, Flagstaff, Arizona,
Court of Federal Claims No: 17–
0477V.
5. Hillary Adams, Phoenix, Arizona,
Court of Federal Claims No: 17–
0478V.
6. Emma Sullivan, Phoenix, Arizona,
Court of Federal Claims No: 17–
0480V.
7. Joanne Gurney, Fall River,
Massachusetts, Court of Federal
Claims No: 17–0481V.
8. Daniel Jenson, Hillsboro, North
Dakota, Court of Federal Claims No:
17–0482V.
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]]>Agencies
[Federal Register Volume 82, Number 103 (Wednesday, May 31, 2017)]
[Notices]
[Pages 24977-24980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11188]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0623]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Voluntary Cosmetic Registration Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 invites comments on the collection of information associated
with our Voluntary Cosmetic Registration Program (VCRP).
DATES: Submit either electronic or written comments on the collection
of information by July 31, 2017.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 31, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 31, 2017. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov/.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov/
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov/.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2010-N-0623 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Voluntary Cosmetic Registration
Program.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov/ or at the Division of Dockets Management between
9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov/. Submit both copies to the Division of Dockets
Management. If you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov/ and insert the docket number, found in brackets in
the
[[Page 24978]]
heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila 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: 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 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.
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) decreasing burden to 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 term ``Form FDA 2511'' refers to both the paper
and online versions of the form. 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 of 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 mailing 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.
Currently, under part 720, FDA requests firms that manufacture,
pack, or distribute cosmetics to file with the Agency an ingredient
statement for each of their products. Filing of cosmetic product
ingredient statements is voluntary. Ingredient statements for new
submissions are reported on Form FDA 2512, ``Cosmetic Product
Ingredient Statement,'' and on Form FDA 2512a, a continuation form.
Amendments to product formulations 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, ``Notice of
Discontinuance of Commercial Distribution of Cosmetic Product
Formulation''; however, filers may also notify FDA that they have
discontinued a cosmetic product formulation by submitting an amended
Form FDA 2512, which would obviate the need for Form FDA 2514. If any
of the information submitted on these forms is confidential, the firm
may submit a request for confidentiality of a cosmetic ingredient.
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. They
also assist 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 through the use of a
manual process for
[[Page 24979]]
both filers and FDA reviewers that can 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, 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, 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 fields such as phone number, email, and
alternative authorized individual to Form 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.''
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR Section or Part Form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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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
cosmetics will file 4,049 amendments to
[[Page 24980]]
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: May 25, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11188 Filed 5-30-17; 8:45 am]
BILLING CODE 4164-01-P
