81_FR_74659 81 FR 74452 - 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

81 FR 74452 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 207 (October 26, 2016)

Page Range74452-74453
FR Document2016-25854

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).

Federal Register, Volume 81 Issue 207 (Wednesday, October 26, 2016)
[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Notices]
[Pages 74452-74453]
From the Federal Register Online  [www.thefederalregister.org]
[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 [email protected]. 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, [email protected].

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



                                                    74452                     Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Notices

                                                    for Treatment.’’ The purpose of this                      Dated: October 20, 2016.                            products to establish standardized
                                                    draft guidance is to assist sponsors in                 Leslie Kux,                                           format and content requirements for the
                                                    developing drugs for the treatment of                   Associate Commissioner for Policy.                    labeling of all marketed OTC drug
                                                    low sexual interest, desire, and/or                     [FR Doc. 2016–25788 Filed 10–25–16; 8:45 am]          products in part 201 (21 CFR part 201).
                                                    arousal in women. Specifically, this                    BILLING CODE 4164–01–P
                                                                                                                                                                  The regulations in part 201 require OTC
                                                    draft guidance addresses FDA’s current                                                                        drug product labeling to include
                                                    thinking regarding the overall clinical                                                                       uniform headings and subheadings,
                                                    development program, with a focus on                    DEPARTMENT OF HEALTH AND                              presented in a standardized order, with
                                                    phase 3 trial designs, to support an                    HUMAN SERVICES                                        minimum standards for type size and
                                                                                                                                                                  other graphical features. Specifically,
                                                    indication for the treatment of these
                                                                                                            Food and Drug Administration                          the 1999 labeling final rule added new
                                                    conditions.
                                                                                                                                                                  § 201.66 to part 201. Section 201.66 sets
                                                       On October 27, 2014, FDA convened                    [Docket No. FDA–2013–N–0823]
                                                                                                                                                                  content and format requirements for the
                                                    a public patient-focused drug                           Agency Information Collection                         Drug Facts portion of labels on OTC
                                                    development meeting and heard directly                  Activities; Submission for Office of                  drug products.
                                                    from women suffering from female                        Management and Budget Review;                           On June 20, 2000 (65 FR 38191), we
                                                    sexual desire and arousal disorders. The                Comment Request; Format and                           published a Federal Register final rule
                                                    following day, FDA held a public                        Content Requirements for Over-the-                    that required all OTC drug products
                                                    scientific workshop with invited experts                Counter Drug Product Labeling                         marketed under the OTC monograph
                                                    in sexual medicine to discuss scientific                                                                      system to comply with the labeling
                                                    challenges involved in developing drugs                 AGENCY:    Food and Drug Administration,              requirements in § 201.66 by May 16,
                                                    to treat these disorders, including                     HHS.                                                  2005, or sooner (65 FR 38191 at 38193).
                                                    diagnostic criteria, endpoints, and                     ACTION:   Notice.                                     Currently marketed OTC drug products
                                                    patient-reported outcome instruments.                                                                         are already required to be in compliance
                                                                                                            SUMMARY:   The Food and Drug                          with these labeling requirements, and
                                                    Comments from the public and experts                    Administration (FDA or we) is                         thus will incur no further burden to
                                                    that were communicated during these                     announcing that a proposed collection                 comply with Drug Facts labeling
                                                    proceedings, as well as comments                        of information has been submitted to the              requirements in § 201.66. Modifications
                                                    submitted to FDA through the public                     Office of Management and Budget                       of labeling already required to be in
                                                    docket, were used to inform this draft                  (OMB) for review and clearance under                  Drug Facts format are usual and
                                                    guidance.                                               the Paperwork Reduction Act of 1995                   customary as part of routine redesign
                                                       This draft guidance is being issued                  (the PRA).                                            practice, and thus do not create
                                                    consistent with FDA’s good guidance                     DATES: Fax written comments on the                    additional burden within the meaning
                                                    practices regulation (21 CFR 10.115).                   collection of information by November                 of the PRA. Therefore, the burden to
                                                    The draft guidance, when finalized, will                25, 2016.                                             comply with the labeling requirements
                                                    represent the current thinking of FDA                   ADDRESSES: To ensure that comments on                 in § 201.66 is a one-time burden
                                                    on developing drugs for the treatment of                the information collection are received,              applicable only to new OTC drug
                                                    low sexual interest, desire, and/or                     OMB recommends that written                           products introduced to the marketplace
                                                    arousal in women. It does not establish                 comments be faxed to the Office of                    under new drug applications (NDAs),
                                                    any rights for any person and is not                    Information and Regulatory Affairs,                   abbreviated new drug applications
                                                    binding on FDA or the public. You can                   OMB, Attn: FDA Desk Officer, FAX:                     (ANDAs), or an OTC drug monograph,
                                                    use an alternative approach if it satisfies             202–395–7285, or emailed to oira_                     except for products in ‘‘convenience
                                                    the requirements of the applicable                      submission@omb.eop.gov. All                           size’’ packages.1 New OTC drug
                                                                                                            comments should be identified with the                products must comply with the labeling
                                                    statutes and regulations.
                                                                                                            OMB control number 0910–0340. Also                    requirements in § 201.66 as they are
                                                    II. The Paperwork Reduction Act of                      include the FDA docket number found                   introduced to the marketplace.
                                                    1995                                                    in brackets in the heading of this                      Based on a March 1, 2010, estimate
                                                                                                            document.                                             provided by the Consumer Healthcare
                                                      This draft guidance refers to                                                                               Products Association (75 FR 49495 at
                                                    previously approved collections of                      FOR FURTHER INFORMATION CONTACT:    FDA               49496, August 13, 2010), we estimated
                                                    information found in FDA regulations.                   PRA Staff, Office of Operations, Food                 that approximately 900 new OTC drug
                                                                                                            and Drug Administration, Three White                  product stock-keeping units (SKUs) are
                                                    These collections of information are
                                                                                                            Flint North, 10A63, 11601 Landsdown                   introduced to the marketplace each
                                                    subject to review by the Office of
                                                                                                            St., North Bethesda, MD 20852,
                                                    Management and Budget (OMB) under
                                                                                                            PRAStaff@fda.hhs.gov.                                    1 In a final rule published in the Federal Register
                                                    the Paperwork Reduction Act of 1995
                                                                                                            SUPPLEMENTARY INFORMATION: In                         of April 5, 2002, the Agency delayed the
                                                    (44 U.S.C. 3501–3520). The collections                                                                        compliance dates for the 1999 labeling final rule for
                                                                                                            compliance with 44 U.S.C. 3507, FDA
                                                    of information in 21 CFR part 314 have                                                                        all OTC drug products that: (1) Contain no more
                                                                                                            has submitted the following proposed
                                                    been approved under OMB Control                         collection of information to OMB for
                                                                                                                                                                  than two doses of an OTC drug and (2) because of
                                                                                                                                                                  their limited available labeling space, would require
                                                    Number 0910–0001.                                       review and clearance.                                 more than 60 percent of the total surface area
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    III. Electronic Access                                                                                        available to bear labeling to meet the requirements
                                                                                                            Format and Content Requirements for                   set forth in § 201.66(d)(1) and (9) and, therefore,
                                                      Persons with access to the Internet                   OTC Drug Product Labeling—21 CFR                      qualify for the labeling modifications currently set
                                                                                                            Part 201—OMB Control Number 0910–                     forth in § 201.66(d)(10) (67 FR 16304 at 16306). The
                                                    may obtain the draft guidance at either                                                                       Agency issued this delay in order to develop
                                                                                                            0340—Extension
                                                    http://www.fda.gov/Drugs/Guidance                                                                             additional rulemaking for these ‘‘convenience size’’
                                                                                                               In the Federal Register of March 17,               products (December 12, 2006; 71 FR 74474). These
                                                    ComplianceRegulatoryInformation/                                                                              products are not currently subject to the
                                                    Guidances/default.htm or http://                        1999 (64 FR 13254) (the 1999 labeling                 requirements of § 201.66. PRA approval for any
                                                    www.regulations.gov.                                    final rule), we amended our regulations               requirements to which they may be subject in the
                                                                                                            governing requirements for human drug                 future will be handled in a separate rulemaking.



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                                                                                       Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Notices                                                                                               74453

                                                    year. We estimated that these SKUs are                                     of OTC sunscreen drug products would                                        equal to 0.1. In the 1999 labeling final
                                                    marketed by 300 manufacturers. We                                          be marketed each year (77 FR 27230 at                                       rule, we estimated that a request for
                                                    estimated that the preparation of                                          27234). We estimate that these 60 SKUs                                      deferral or exemption would require 24
                                                    labeling for new OTC drug products                                         would be marketed by 20                                                     hours to complete (64 FR 13254 at
                                                    would require 12 hours to prepare,                                         manufacturers. We estimate that                                             13276). We continue to estimate that
                                                    complete, and review prior to                                              approximately 12 hours would be spent                                       this type of response will require
                                                    submitting the new labeling to us. Based                                   on each label, based on the most recent                                     approximately 24 hours. Multiplying
                                                    on this estimate, the annual reporting                                     estimate used for other OTC drug                                            the annual frequency of response (0.1)
                                                    burden for this type of labeling is                                        products to comply with the 1999 Drug                                       by the number of hours per response
                                                    approximately 10,800 hours.                                                Facts labeling final rule, including
                                                                                                                                                                                                           (24) gives a total response time for
                                                      All currently marketed sunscreen                                         public comments received on this
                                                    products are required to be in                                                                                                                         requesting exemption of deferral equal
                                                                                                                               estimate in 2010 that addressed
                                                    compliance with the Drug Facts labeling                                    sunscreens.                                                                 to 3 hours.
                                                    requirements in § 201.66, and thus will                                       In determining the burden for                                              In the Federal Register of April 1,
                                                    incur no further burden under the                                          § 201.66, it is also important to consider                                  2016 (81 FR 18861), we published a 60-
                                                    information collection provisions in the                                   exemptions or deferrals of the regulation                                   day notice requesting public comment
                                                    1999 labeling final rule. However, a new                                   allowed products under § 201.66(e).                                         on the proposed extension of this
                                                    OTC sunscreen drug product, like any                                       Since publication of the 1999 labeling                                      collection of information. No comments
                                                    new OTC drug product, will be subject                                      final rule, we have received only one                                       were received.
                                                    to a one-time burden to comply with                                        request for exemption or deferral. One
                                                                                                                                                                                                             FDA estimates the burden of this
                                                    Drug Facts labeling requirements in                                        response over a 10-year period equates
                                                                                                                                                                                                           collection of information as follows:
                                                    § 201.66. We estimate that 60 new SKUs                                     to an annual frequency of response

                                                                                                            TABLE 1—ESTIMATED THIRD-PARTY DISCLOSURE BURDEN 1
                                                                                                                                                                              Number of                                               Average
                                                                                                                                                   Number of                  disclosures               Total annual
                                                                                    21 CFR section                                                                                                                                   burden per              Total hours
                                                                                                                                                  respondents                     per                   disclosures                  disclosure
                                                                                                                                                                              respondent

                                                    201.66(c) and (d) for new OTC drug products ....................                                               300                         3                         900                          12           10,800
                                                    201.66(c) and (d) for new OTC sunscreen products ..........                                                     20                         3                          60                          12              720
                                                    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.                                                 after the publication of the notice of the                                  DEPARTMENT OF HEALTH AND
                                                    Leslie Kux,                                                                workshop. This document corrects that                                       HUMAN SERVICES
                                                    Associate Commissioner for Policy.                                         error.
                                                    [FR Doc. 2016–25854 Filed 10–25–16; 8:45 am]                                                                                                           Food and Drug Administration
                                                                                                                               FOR FURTHER INFORMATION CONTACT:
                                                    BILLING CODE 4164–01–P                                                     Chris Nguyen, Center for Biologics                                          [Docket No. FDA–2013–N–0730]
                                                                                                                               Evaluation and Research, Food and
                                                                                                                               Drug Administration, 10903 New                                              Agency Information Collection
                                                    DEPARTMENT OF HEALTH AND                                                   Hampshire Ave., Bldg. 71, Rm. 4124,                                         Activities; Submission for Office of
                                                    HUMAN SERVICES                                                             Silver Spring, MD 20993–0002; or                                            Management and Budget Review;
                                                                                                                               Cynthia Whitmarsh, Center for Biologics                                     Comment Request; Threshold of
                                                    Food and Drug Administration                                                                                                                           Regulation for Substances Used in
                                                                                                                               Evaluation and Research, Food and
                                                    [Docket No. FDA–2016–N–0001]                                               Drug Administration, 10903 New                                              Food-Contact Articles
                                                                                                                               Hampshire Ave., Bldg. 71, Rm. 4122,                                         AGENCY:         Food and Drug Administration,
                                                    The Sentinel Post-Licensure Rapid                                          Silver Spring, MD 20993–0002.                                               HHS.
                                                    Immunization Safety Monitoring
                                                    Program; Public Workshop; Correction                                       SUPPLEMENTARY INFORMATION:      In the                                      ACTION:        Notice.
                                                                                                                               Federal Register of September 1, 2016,
                                                    AGENCY:        Food and Drug Administration,                               in FR Doc. 2016–21046, on page 60357,                                       SUMMARY:   The Food and Drug
                                                    HHS.                                                                       the following correction is made:                                           Administration (FDA) is announcing
                                                                                                                                                                                                           that a proposed collection of
                                                    ACTION: Notice of public workshop;                                           On page 60357, in the third column                                        information has been submitted to the
                                                    correction.                                                                under the SUPPLEMENTARY INFORMATION                                         Office of Management and Budget
                                                                                                                               caption, the fifth sentence in the second                                   (OMB) for review and clearance under
                                                    SUMMARY:   The Food and Drug                                               paragraph is corrected to read ‘‘More
                                                    Administration (FDA) is correcting a                                                                                                                   the Paperwork Reduction Act of 1995.
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                                                                                               information can be found at: https://
                                                    notice that appeared in the Federal                                                                                                                    DATES: Fax written comments on the
                                                                                                                               www.sentinelsystem.org/vaccines-blood-
                                                    Register of Thursday, September 1, 2016                                    biologics.’’                                                                collection of information by November
                                                    (81 FR 60357). The document                                                                                                                            25, 2016.
                                                    announced a public workshop entitled                                         Dated: October 20, 2016.                                                  ADDRESSES: To ensure that comments on
                                                    ‘‘The Sentinel Post-Licensure Rapid                                        Leslie Kux,                                                                 the information collection are received,
                                                    Immunization Safety Monitoring                                             Associate Commissioner for Policy.                                          OMB recommends that written
                                                    (PRISM) Program.’’ The document was                                        [FR Doc. 2016–25853 Filed 10–25–16; 8:45 am]                                comments be faxed to the Office of
                                                    published with a Web site that changed                                     BILLING CODE 4164–01–P                                                      Information and Regulatory Affairs,


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Document Created: 2016-10-26 02:17:24
Document Modified: 2016-10-26 02:17:24
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by November 25, 2016.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation81 FR 74452 

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