81 FR 18861 - Agency Information Collection Activities; Proposed Collection; 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 63 (April 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 63 (April 1, 2016)
| Page Range | 18861-18863 | |
| FR Document | 2016-07369 |
[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)] [Notices] [Pages 18861-18863] From the Federal Register Online [www.thefederalregister.org] [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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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, [email protected]. 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
![Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices 18861
one non-voting member who is Electronic Submissions submission. You should submit two
identified with industry interests. Submit electronic comments in the copies total. One copy will include the
Further information regarding the following way: information you claim to be confidential
most recent charter and other • Federal eRulemaking Portal: http:// with a heading or cover note that states
information can be found at http:// www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
www.fda.gov/AdvisoryCommittees/ instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
CommitteesMeetingMaterials/Drugs/ Comments submitted electronically, Agency will review this copy, including
ArthritisAdvisoryCommittee/ including attachments, to http:// the claimed confidential information, in
ucm094137.htm or by contacting the www.regulations.gov will be posted to its consideration of comments. The
Designated Federal Officer (see FOR second copy, which will have the
the docket unchanged. Because your
FURTHER INFORMATION CONTACT). In light claimed confidential information
comment will be made public, you are
of the fact that no change has been made redacted/blacked out, will be available
solely responsible for ensuring that your
to the committee name or description of for public viewing and posted on http://
comment does not include any
duties, no amendment will be made to www.regulations.gov. Submit both
confidential information that you or a
21 CFR 14.100. copies to the Division of Dockets
third party may not wish to be posted,
This document is issued under the Management. If you do not wish your
such as medical information, your or
Federal Advisory Committee Act (5 name and contact information to be
anyone else’s Social Security number, or
U.S.C. app.). For general information made publicly available, you can
confidential business information, such
related to FDA advisory committees, provide this information on the cover
as a manufacturing process. Please note
please visit us at http://www.fda.gov/ sheet and not in the body of your
that if you include your name, contact
AdvisoryCommittees/default.htm. comments and you must identify this
information, or other information that
information as ‘‘confidential.’’ Any
Dated: March 25, 2016. identifies you in the body of your
information marked as ‘‘confidential’’
Leslie Kux, comments, that information will be
will not be disclosed except in
posted on http://www.regulations.gov.
Associate Commissioner for Policy. accordance with 21 CFR 10.20 and other
• If you want to submit a comment
[FR Doc. 2016–07362 Filed 3–31–16; 8:45 am] applicable disclosure law. For more
with confidential information that you
BILLING CODE 4164–01–P information about FDA’s posting of
do not wish to be made available to the
comments to public dockets, see 80 FR
public, submit the comment as a
56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND written/paper submission and in the
the information at: http://www.fda.gov/
HUMAN SERVICES manner detailed (see ‘‘Written/Paper
regulatoryinformation/dockets/
Submissions’’ and ‘‘Instructions’’).
default.htm.
Food and Drug Administration Written/Paper Submissions Docket: For access to the docket to
read background documents or the
Submit written/paper submissions as
[Docket No. FDA–2013–N–0823] electronic and written/paper comments
follows:
received, go to http://
Agency Information Collection • Mail/Hand delivery/Courier (for
www.regulations.gov and insert the
Activities; Proposed Collection; written/paper submissions): Division of
docket number, found in brackets in the
Comment Request; Format and Dockets Management (HFA–305), Food
heading of this document, into the
Content Requirements for Over-the- and Drug Administration, 5630 Fishers
‘‘Search’’ box and follow the prompts
Counter Drug Product Labeling Lane, Rm. 1061, Rockville, MD 20852.
and/or go to the Division of Dockets
• For written/paper comments
Management, 5630 Fishers Lane, Rm.
AGENCY: Food and Drug Administration, submitted to the Division of Dockets
1061, Rockville, MD 20852.
HHS. Management, FDA will post your
comment, as well as any attachments, FOR FURTHER INFORMATION CONTACT: FDA
ACTION: Notice. PRA Staff, Office of Operations, Food
except for information submitted,
marked and identified, as confidential, and Drug Administration, 8455
SUMMARY: The Food and Drug Colesville Rd., COLE–14526, Silver
Administration (FDA) is announcing an if submitted as detailed in
‘‘Instructions.’’ Spring, MD 20993–0002, PRAStaff@
opportunity for public comment on the fda.hhs.gov.
proposed collection of certain Instructions: All submissions received
information by the Agency. Under the must include the Docket No. FDA– SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (the 2013–N–0823 for ‘‘Agency Information PRA (44 U.S.C. 3501–3520), Federal
PRA), Federal Agencies are required to Collection Activities; Proposed Agencies must obtain approval from the
publish notice in the Federal Register Collection; Comment Request; Format Office of Management and Budget
concerning each proposed collection of and Content Requirements for Over-the- (OMB) for each collection of
information, including each proposed Counter Drug Product Labeling.’’ information they conduct or sponsor.
extension of an existing collection of Received comments will be placed in ‘‘Collection of information’’ is defined
information, and to allow 60 days for the docket and, except for those in 44 U.S.C. 3502(3) and 5 CFR
public comment in response to the submitted as ‘‘Confidential 1320.3(c) and includes Agency requests
notice. This notice solicits comments on Submissions,’’ publicly viewable at or requirements that members of the
http://www.regulations.gov or at the public submit reports, keep records, or
asabaliauskas on DSK3SPTVN1PROD with NOTICES
the standardized format and content
requirements for the labeling of over- Division of Dockets Management provide information to a third party.
the-counter (OTC) drug products. between 9 a.m. and 4 p.m., Monday Section 3506(c)(2)(A) of the PRA (44
through Friday. U.S.C. 3506(c)(2)(A)) requires Federal
DATES: Submit either electronic or • Confidential Submissions—To Agencies to provide a 60-day notice in
written comments on the collection of submit a comment with confidential the Federal Register concerning each
information by May 31, 2016. information that you do not wish to be proposed collection of information,
ADDRESSES: You may submit comments made publicly available, submit your including each proposed extension of an
as follows: comments only as a written/paper existing collection of information,
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![Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices 18863
Dated: March 29, 2016. ACTION: Notice. The OMB control number and
Leslie Kux, expiration date of OMB approval for
Associate Commissioner for Policy. SUMMARY: The Food and Drug each information collection are shown
[FR Doc. 2016–07369 Filed 3–31–16; 8:45 am]
Administration (FDA) is publishing a in table 1. Copies of the supporting
list of information collections that have statements for the information
BILLING CODE 4164–01–P
been approved by the Office of collections are available on the Internet
Management and Budget (OMB) under
at http://www.reginfo.gov/public/do/
DEPARTMENT OF HEALTH AND the Paperwork Reduction Act of 1995.
PRAMain. An Agency may not conduct
HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: FDA or sponsor, and a person is not required
PRA Staff, Office of Operations, Food to respond to, a collection of
Food and Drug Administration and Drug Administration, 8455 information unless it displays a
[Docket Nos. FDA–2012–N–0471, FDA– Colesville Rd., COLE–14526, Silver currently valid OMB control number.
2012–N–0294] Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
Agency Information Collection
SUPPLEMENTARY INFORMATION: The
Activities; Announcement of Office of
following is a list of FDA information
Management and Budget Approvals
collections recently approved by OMB
AGENCY: Food and Drug Administration, under section 3507 of the Paperwork
HHS. Reduction Act of 1995 (44 U.S.C. 3507).
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
Date
OMB Control
Title of collection approval
number expires
Prescription Drug User Fee Cover Sheet; Form FDA 3397 ................................................................................... 0910–0297 3/31/2019
Food Additives; Food Contact Substances Notification System ............................................................................. 0910–0495 3/31/2019
Dated: March 28, 2016. ADDRESSES: Submit your comments to implementing high quality home
Leslie Kux, paperwork@hrsa.gov or mail the HRSA visiting programs and coordinating with
Associate Commissioner for Policy. Information Collection Clearance comprehensive statewide early
[FR Doc. 2016–07363 Filed 3–31–16; 8:45 am] Officer, Room 14N–39, Parklawn childhood systems. All fifty states, the
BILLING CODE 4164–01–P
Building, 5600 Fishers Lane, Rockville, District of Columbia, five territories, and
MD 20857. nonprofit organizations that would
FOR FURTHER INFORMATION CONTACT: To provide services in jurisdictions that
DEPARTMENT OF HEALTH AND request more information on the have not directly applied for or been
HUMAN SERVICES proposed project or to obtain a copy of approved for a grant are eligible to
the data collection plans and draft receive formula grant awards. There are
Health Resources and Services instruments, email paperwork@hrsa.gov currently 56 entities with formula grant
Administration or call the HRSA Information Collection awards.
Clearance Officer at (301) 443–1984. Need and Proposed Use of the
Agency Information Collection Information: This information collection
Activities: Proposed Collection: Public SUPPLEMENTARY INFORMATION: When is requested for eligible entities to
Comment Request submitting comments or requesting submit applications in response to
information, please include the annual formula Funding Opportunity
AGENCY:Health Resources and Services information request collection title for Announcements (FOA) beginning in
Administration, HHS. reference. Fiscal Year (FY) 2017.
Information Collection Request Title: On March 23, 2010, the President
ACTION: Notice. Maternal, Infant, and Early Childhood signed into law the Patient Protection
Home Visiting Program Funding and Affordable Care Act (ACA). Section
SUMMARY: In compliance with the Opportunity Announcement for
requirement for opportunity for public 2951 of the ACA amended Title V of the
Formula Grant Awards OMB No. 0906– Social Security Act by adding a new
comment on proposed data collection xxxx—New.
projects (Section 3506(c)(2)(A) of the section, 511, which authorized the
Abstract: The Maternal, Infant, and creation of the Federal Home Visiting
Paperwork Reduction Act of 1995), the
Early Childhood Home Visiting (Federal Program. A portion of funding under
Health Resources and Services
Home Visiting) Program, administered this program is awarded to participating
Administration (HRSA) announces
by the Health Resources and Services states and eligible jurisdictions using a
plans to submit an Information
Administration (HRSA) in close funding formula. Formula funding is the
Collection Request (ICR), described
partnership with the Administration for main funding mechanism used by
asabaliauskas on DSK3SPTVN1PROD with NOTICES
below, to the Office of Management and
Children and Families (ACF), supports HRSA to provide support to eligible
Budget (OMB). Prior to submitting the
voluntary, evidence-based home visiting entities for the provision of voluntary
ICR to OMB, HRSA seeks comments
services during pregnancy and to high-quality home visiting services to
from the public regarding the burden
parents with young children up to families living in at-risk communities.
estimate, below, or any other aspect of
kindergarten entry. Formula grant The information collected will be
the ICR.
awards support Federal Home Visiting used to provide guidance to eligible
DATES: Comments on this ICR should be Program grantees in meeting statutory entities on how to prepare and submit
received no later than May 31, 2016. and programmatic objectives for applications in response to annual
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Document Created: 2016-04-06 00:07:53
Document Modified: 2016-04-06 00:07:53
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by May 31, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 18861 |
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