Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling, 74452-74453 [2016-25854]
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74452
Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Notices
for Treatment.’’ The purpose of this
draft guidance is to assist sponsors in
developing drugs for the treatment of
low sexual interest, desire, and/or
arousal in women. Specifically, this
draft guidance addresses FDA’s current
thinking regarding the overall clinical
development program, with a focus on
phase 3 trial designs, to support an
indication for the treatment of these
conditions.
On October 27, 2014, FDA convened
a public patient-focused drug
development meeting and heard directly
from women suffering from female
sexual desire and arousal disorders. The
following day, FDA held a public
scientific workshop with invited experts
in sexual medicine to discuss scientific
challenges involved in developing drugs
to treat these disorders, including
diagnostic criteria, endpoints, and
patient-reported outcome instruments.
Comments from the public and experts
that were communicated during these
proceedings, as well as comments
submitted to FDA through the public
docket, were used to inform this draft
guidance.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on developing drugs for the treatment of
low sexual interest, desire, and/or
arousal in women. It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. The Paperwork Reduction Act of
1995
asabaliauskas on DSK3SPTVN1PROD with NOTICES
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 314 have
been approved under OMB Control
Number 0910–0001.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
VerDate Sep<11>2014
18:25 Oct 25, 2016
Jkt 241001
Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25788 Filed 10–25–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0823]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Format and
Content Requirements for Over-theCounter Drug Product Labeling
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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
(the PRA).
DATES: Fax written comments on the
collection of information by November
25, 2016.
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 0910–0340. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
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.
FOR FURTHER INFORMATION CONTACT:
Format and Content Requirements for
OTC Drug Product Labeling—21 CFR
Part 201—OMB Control Number 0910–
0340—Extension
In the Federal Register of March 17,
1999 (64 FR 13254) (the 1999 labeling
final rule), we amended our regulations
governing requirements for human drug
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
products to establish standardized
format and content requirements for the
labeling of all marketed OTC drug
products in part 201 (21 CFR part 201).
The regulations in part 201 require OTC
drug product labeling to include
uniform headings and subheadings,
presented in a standardized order, with
minimum standards for type size and
other graphical features. Specifically,
the 1999 labeling final rule added new
§ 201.66 to part 201. Section 201.66 sets
content and format requirements for the
Drug Facts portion of labels on OTC
drug products.
On June 20, 2000 (65 FR 38191), we
published a Federal Register final rule
that required all OTC drug products
marketed under the OTC monograph
system to comply with the labeling
requirements in § 201.66 by May 16,
2005, or sooner (65 FR 38191 at 38193).
Currently marketed OTC drug products
are already required to be in compliance
with these labeling requirements, and
thus will incur no further burden to
comply with Drug Facts labeling
requirements in § 201.66. Modifications
of labeling already required to be in
Drug Facts format are usual and
customary as part of routine redesign
practice, and thus do not create
additional burden within the meaning
of the PRA. Therefore, the burden to
comply with the labeling requirements
in § 201.66 is a one-time burden
applicable only to new OTC drug
products introduced to the marketplace
under new drug applications (NDAs),
abbreviated new drug applications
(ANDAs), or an OTC drug monograph,
except for products in ‘‘convenience
size’’ packages.1 New OTC drug
products must comply with the labeling
requirements in § 201.66 as they are
introduced to the marketplace.
Based on a March 1, 2010, estimate
provided by the Consumer Healthcare
Products Association (75 FR 49495 at
49496, August 13, 2010), we estimated
that approximately 900 new OTC drug
product stock-keeping units (SKUs) are
introduced to the marketplace each
1 In a final rule published in the Federal Register
of April 5, 2002, the Agency delayed the
compliance dates for the 1999 labeling final rule for
all OTC drug products that: (1) Contain no more
than two doses of an OTC drug and (2) because of
their limited available labeling space, would require
more than 60 percent of the total surface area
available to bear labeling to meet the requirements
set forth in § 201.66(d)(1) and (9) and, therefore,
qualify for the labeling modifications currently set
forth in § 201.66(d)(10) (67 FR 16304 at 16306). The
Agency issued this delay in order to develop
additional rulemaking for these ‘‘convenience size’’
products (December 12, 2006; 71 FR 74474). These
products are not currently subject to the
requirements of § 201.66. PRA approval for any
requirements to which they may be subject in the
future will be handled in a separate rulemaking.
E:\FR\FM\26OCN1.SGM
26OCN1
74453
Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Notices
year. We estimated that these SKUs are
marketed by 300 manufacturers. We
estimated that the preparation of
labeling for new OTC drug products
would require 12 hours to prepare,
complete, and review prior to
submitting the new labeling to us. Based
on this estimate, the annual reporting
burden for this type of labeling is
approximately 10,800 hours.
All currently marketed sunscreen
products are required to be in
compliance with the Drug Facts labeling
requirements in § 201.66, and thus will
incur no further burden under the
information collection provisions in the
1999 labeling final rule. However, a new
OTC sunscreen drug product, like any
new OTC drug product, will be subject
to a one-time burden to comply with
Drug Facts labeling requirements in
§ 201.66. We estimate that 60 new SKUs
of OTC sunscreen drug products would
be marketed each year (77 FR 27230 at
27234). We estimate that these 60 SKUs
would be marketed by 20
manufacturers. We estimate that
approximately 12 hours would be spent
on each label, based on the most recent
estimate used for other OTC drug
products to comply with the 1999 Drug
Facts labeling final rule, including
public comments received on this
estimate in 2010 that addressed
sunscreens.
In determining the burden for
§ 201.66, it is also important to consider
exemptions or deferrals of the regulation
allowed products under § 201.66(e).
Since publication of the 1999 labeling
final rule, we have received only one
request for exemption or deferral. One
response over a 10-year period equates
to an annual frequency of response
equal to 0.1. In the 1999 labeling final
rule, we estimated that a request for
deferral or exemption would require 24
hours to complete (64 FR 13254 at
13276). We continue to estimate that
this type of response will require
approximately 24 hours. Multiplying
the annual frequency of response (0.1)
by the number of hours per response
(24) gives a total response time for
requesting exemption of deferral equal
to 3 hours.
In the Federal Register of April 1,
2016 (81 FR 18861), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
201.66(c) and (d) for new OTC drug products ....................
201.66(c) and (d) for new OTC sunscreen products ..........
201.66(e) ..............................................................................
300
20
1
3
3
0.125
900
60
.125
12
12
24
10,800
720
3
Total ..............................................................................
........................
........................
........................
........................
11,523
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
after the publication of the notice of the
workshop. This document corrects that
error.
[FR Doc. 2016–25854 Filed 10–25–16; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
Chris Nguyen, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 4124,
Silver Spring, MD 20993–0002; or
Cynthia Whitmarsh, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 4122,
Silver Spring, MD 20993–0002.
[Docket No. FDA–2013–N–0730]
In the
Federal Register of September 1, 2016,
in FR Doc. 2016–21046, on page 60357,
the following correction is made:
On page 60357, in the third column
under the SUPPLEMENTARY INFORMATION
caption, the fifth sentence in the second
paragraph is corrected to read ‘‘More
information can be found at: https://
www.sentinelsystem.org/vaccines-bloodbiologics.’’
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
The Sentinel Post-Licensure Rapid
Immunization Safety Monitoring
Program; Public Workshop; Correction
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
correction.
ACTION:
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of Thursday, September 1, 2016
(81 FR 60357). The document
announced a public workshop entitled
‘‘The Sentinel Post-Licensure Rapid
Immunization Safety Monitoring
(PRISM) Program.’’ The document was
published with a Web site that changed
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:25 Oct 25, 2016
Jkt 241001
SUPPLEMENTARY INFORMATION:
Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–25853 Filed 10–25–16; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Threshold of
Regulation for Substances Used in
Food-Contact Articles
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) 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 November
25, 2016.
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,
SUMMARY:
E:\FR\FM\26OCN1.SGM
26OCN1
Agencies
[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Notices]
[Pages 74452-74453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25854]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0823]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Format and Content
Requirements for Over-the-Counter Drug Product Labeling
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 (the PRA).
DATES: Fax written comments on the collection of information by
November 25, 2016.
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 0910-0340.
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, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 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.
Format and Content Requirements for OTC Drug Product Labeling--21 CFR
Part 201--OMB Control Number 0910-0340--Extension
In the Federal Register of March 17, 1999 (64 FR 13254) (the 1999
labeling final rule), we amended our regulations governing requirements
for human drug products to establish standardized format and content
requirements for the labeling of all marketed OTC drug products in part
201 (21 CFR part 201). The regulations in part 201 require OTC drug
product labeling to include uniform headings and subheadings, presented
in a standardized order, with minimum standards for type size and other
graphical features. Specifically, the 1999 labeling final rule added
new Sec. 201.66 to part 201. Section 201.66 sets content and format
requirements for the Drug Facts portion of labels on OTC drug products.
On June 20, 2000 (65 FR 38191), we published a Federal Register
final rule that required all OTC drug products marketed under the OTC
monograph system to comply with the labeling requirements in Sec.
201.66 by May 16, 2005, or sooner (65 FR 38191 at 38193). Currently
marketed OTC drug products are already required to be in compliance
with these labeling requirements, and thus will incur no further burden
to comply with Drug Facts labeling requirements in Sec. 201.66.
Modifications of labeling already required to be in Drug Facts format
are usual and customary as part of routine redesign practice, and thus
do not create additional burden within the meaning of the PRA.
Therefore, the burden to comply with the labeling requirements in Sec.
201.66 is a one-time burden applicable only to new OTC drug products
introduced to the marketplace under new drug applications (NDAs),
abbreviated new drug applications (ANDAs), or an OTC drug monograph,
except for products in ``convenience size'' packages.\1\ New OTC drug
products must comply with the labeling requirements in Sec. 201.66 as
they are introduced to the marketplace.
---------------------------------------------------------------------------
\1\ In a final rule published in the Federal Register of April
5, 2002, the Agency delayed the compliance dates for the 1999
labeling final rule for all OTC drug products that: (1) Contain no
more than two doses of an OTC drug and (2) because of their limited
available labeling space, would require more than 60 percent of the
total surface area available to bear labeling to meet the
requirements set forth in Sec. 201.66(d)(1) and (9) and, therefore,
qualify for the labeling modifications currently set forth in Sec.
201.66(d)(10) (67 FR 16304 at 16306). The Agency issued this delay
in order to develop additional rulemaking for these ``convenience
size'' products (December 12, 2006; 71 FR 74474). These products are
not currently subject to the requirements of Sec. 201.66. PRA
approval for any requirements to which they may be subject in the
future will be handled in a separate rulemaking.
---------------------------------------------------------------------------
Based on a March 1, 2010, estimate provided by the Consumer
Healthcare Products Association (75 FR 49495 at 49496, August 13,
2010), we estimated that approximately 900 new OTC drug product stock-
keeping units (SKUs) are introduced to the marketplace each
[[Page 74453]]
year. We estimated that these SKUs are marketed by 300 manufacturers.
We estimated that the preparation of labeling for new OTC drug products
would require 12 hours to prepare, complete, and review prior to
submitting the new labeling to us. Based on this estimate, the annual
reporting burden for this type of labeling is approximately 10,800
hours.
All currently marketed sunscreen products are required to be in
compliance with the Drug Facts labeling requirements in Sec. 201.66,
and thus will incur no further burden under the information collection
provisions in the 1999 labeling final rule. However, a new OTC
sunscreen drug product, like any new OTC drug product, will be subject
to a one-time burden to comply with Drug Facts labeling requirements in
Sec. 201.66. We estimate that 60 new SKUs of OTC sunscreen drug
products would be marketed each year (77 FR 27230 at 27234). We
estimate that these 60 SKUs would be marketed by 20 manufacturers. We
estimate that approximately 12 hours would be spent on each label,
based on the most recent estimate used for other OTC drug products to
comply with the 1999 Drug Facts labeling final rule, including public
comments received on this estimate in 2010 that addressed sunscreens.
In determining the burden for Sec. 201.66, it is also important to
consider exemptions or deferrals of the regulation allowed products
under Sec. 201.66(e). Since publication of the 1999 labeling final
rule, we have received only one request for exemption or deferral. One
response over a 10-year period equates to an annual frequency of
response equal to 0.1. In the 1999 labeling final rule, we estimated
that a request for deferral or exemption would require 24 hours to
complete (64 FR 13254 at 13276). We continue to estimate that this type
of response will require approximately 24 hours. Multiplying the annual
frequency of response (0.1) by the number of hours per response (24)
gives a total response time for requesting exemption of deferral equal
to 3 hours.
In the Federal Register of April 1, 2016 (81 FR 18861), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average
21 CFR section respondents per disclosures burden per Total hours
respondent disclosure
----------------------------------------------------------------------------------------------------------------
201.66(c) and (d) for new OTC 300 3 900 12 10,800
drug products..................
201.66(c) and (d) for new OTC 20 3 60 12 720
sunscreen products.............
201.66(e)....................... 1 0.125 .125 24 3
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 11,523
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25854 Filed 10-25-16; 8:45 am]
BILLING CODE 4164-01-P