Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling, 18861-18863 [2016-07369]

Download as PDF Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices one non-voting member who is identified with industry interests. Further information regarding the most recent charter and other information can be found at https:// www.fda.gov/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ ArthritisAdvisoryCommittee/ ucm094137.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100. This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please visit us at https://www.fda.gov/ AdvisoryCommittees/default.htm. Dated: March 25, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–07362 Filed 3–31–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for Over-theCounter Drug Product Labeling Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 solicits comments on the standardized format and content requirements for the labeling of overthe-counter (OTC) drug products. DATES: Submit either electronic or written comments on the collection of information by May 31, 2016. ADDRESSES: You may submit comments as follows: asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:10 Mar 31, 2016 Jkt 238001 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 [Docket No. FDA–2013–N–0823] AGENCY: Electronic 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– 2013–N–0823 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for Over-theCounter Drug Product Labeling.’’ Received comments 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 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 18861 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.fda.gov/ regulatoryinformation/dockets/ default.htm. 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 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: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, 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, E:\FR\FM\01APN1.SGM 01APN1 18862 Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices 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. 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 § 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 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 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, March 17, 1999). 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 hour per response (24) gives a total response time for requesting exemption of deferral equal to 3 hours. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED THIRD-PARTY DISCLOSURE BURDEN 1 Number of disclosures per respondent Number of respondents 21 CFR Section Total annual disclosures Average burden per disclosure Total hours 300 20 1 3 3 0.125 900 60 0.125 12 12 24 10,800 720 3 Total ............................................................................ asabaliauskas on DSK3SPTVN1PROD with NOTICES 201.66(c) and (d) for new OTC drug products .................. 201.66(c) and (d) for new OTC sunscreen products ........ 201.66(e) ............................................................................ ........................ .......................... ........................ ........................ 11,523 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 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 VerDate Sep<11>2014 19:10 Mar 31, 2016 Jkt 238001 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 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 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\01APN1.SGM 01APN1 18863 Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices Dated: March 29, 2016. Leslie Kux, Associate Commissioner for Policy. ACTION: The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUMMARY: [FR Doc. 2016–07369 Filed 3–31–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2012–N–0471, FDA– 2012–N–0294] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY: Notice. Food and Drug Administration, HHS. The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the Internet at https://www.reginfo.gov/public/do/ PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). SUPPLEMENTARY INFORMATION: TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB OMB Control number Title of collection Prescription Drug User Fee Cover Sheet; Form FDA 3397 ................................................................................... Food Additives; Food Contact Substances Notification System ............................................................................. Dated: March 28, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–07363 Filed 3–31–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Health Resources and Services Administration, HHS. AGENCY: ACTION: Notice. In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: Comments on this ICR should be received no later than May 31, 2016. DATES: VerDate Sep<11>2014 17:25 Mar 31, 2016 Jkt 238001 Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N–39, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: Maternal, Infant, and Early Childhood Home Visiting Program Funding Opportunity Announcement for Formula Grant Awards OMB No. 0906– xxxx—New. Abstract: The Maternal, Infant, and Early Childhood Home Visiting (Federal Home Visiting) Program, administered by the Health Resources and Services Administration (HRSA) in close partnership with the Administration for Children and Families (ACF), supports voluntary, evidence-based home visiting services during pregnancy and to parents with young children up to kindergarten entry. Formula grant awards support Federal Home Visiting Program grantees in meeting statutory and programmatic objectives for ADDRESSES: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 0910–0297 0910–0495 Date approval expires 3/31/2019 3/31/2019 implementing high quality home visiting programs and coordinating with comprehensive statewide early childhood systems. All fifty states, the District of Columbia, five territories, and nonprofit organizations that would provide services in jurisdictions that have not directly applied for or been approved for a grant are eligible to receive formula grant awards. There are currently 56 entities with formula grant awards. Need and Proposed Use of the Information: This information collection is requested for eligible entities to submit applications in response to annual formula Funding Opportunity Announcements (FOA) beginning in Fiscal Year (FY) 2017. On March 23, 2010, the President signed into law the Patient Protection and Affordable Care Act (ACA). Section 2951 of the ACA amended Title V of the Social Security Act by adding a new section, 511, which authorized the creation of the Federal Home Visiting Program. A portion of funding under this program is awarded to participating states and eligible jurisdictions using a funding formula. Formula funding is the main funding mechanism used by HRSA to provide support to eligible entities for the provision of voluntary high-quality home visiting services to families living in at-risk communities. The information collected will be used to provide guidance to eligible entities on how to prepare and submit applications in response to annual E:\FR\FM\01APN1.SGM 01APN1

Agencies

[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Pages 18861-18863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07369]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0823]


Agency Information Collection Activities; Proposed Collection; 
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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 solicits comments on the standardized format and 
content requirements for the labeling of over-the-counter (OTC) drug 
products.

DATES: Submit either electronic or written comments on the collection 
of information by May 31, 2016.

ADDRESSES: You may submit comments as follows:

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-2013-N-0823 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Format and Content Requirements 
for Over-the-Counter Drug Product Labeling.'' Received comments 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.fda.gov/regulatoryinformation/dockets/default.htm.
    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 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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,

[[Page 18862]]

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.

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 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 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, March 17, 1999). 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 hour per response (24) gives a total response time for requesting 
exemption of deferral equal to 3 hours.
    FDA estimates the burden of this collection of information as 
follows:

                              Table 1--Estimated Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
         21 CFR Section             Number of    disclosures per   Total annual   Average burden    Total hours
                                   respondents      respondent      disclosures   per 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           0.125              24               3
                                --------------------------------------------------------------------------------
    Total......................  ..............  ...............  ..............  ..............          11,523
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



[[Page 18863]]

    Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07369 Filed 3-31-16; 8:45 am]
 BILLING CODE 4164-01-P
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