[Federal Register Volume 83, Number 138 (Wednesday, July 18, 2018)]
[Notices]
[Pages 33938-33939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15296]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2281]


Innovative Approaches for Nonprescription Drug Products; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Innovative 
Approaches for Nonprescription Drug Products.'' This draft guidance 
describes two innovative approaches that may be useful to consider for 
demonstrating safety and effectiveness for a nonprescription drug 
product in cases where the drug facts labeling (DFL) alone is not 
sufficient to ensure that the drug product can be used safely and 
effectively in a nonprescription setting: The development of labeling 
in addition to the DFL and the implementation of additional conditions 
so that consumers appropriately self-select and use the product.

DATES: Submit either electronic or written comments on the draft 
guidance by September 17, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2018-D-2281 for ``Innovative Approaches for Nonprescription Drug 
Products; Draft Guidance for Industry; Availability.'' 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 Dockets Management Staff 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 Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Chris Wheeler, Center for Drug 
Evaluation and Research, 10903 New

[[Page 33939]]

Hampshire Ave., Bldg. 51, Rm. 3330, Silver Spring, MD 20993, 301-796-
0151.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Innovative Approaches for Nonprescription Drug Products.'' 
FDA approves new drugs as prescription or nonprescription drug products 
under section 505 of the Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 355). A drug product must be dispensed by prescription if it is 
not safe to use except under the supervision of a practitioner licensed 
by law to administer the drug (health care practitioner) (see section 
503(b)(1) of the FD&C Act (21 U.S.C. 353(b)(1)). If a drug product does 
not meet the criteria for prescription-only dispensing, it may be 
marketed as a nonprescription drug product. FDA determines whether the 
information submitted as part of a new drug application (NDA) for a 
nonprescription drug product is sufficient to ensure that the drug 
product is safe and effective for nonprescription use under the 
conditions prescribed, recommended, or suggested in its proposed 
labeling (see section 505(d) and 503(b)(1) of the FD&C Act.
    Nonprescription drug products must comply with applicable labeling 
requirements for over-the-counter (OTC) drug products under 21 CFR part 
201, including, but not limited to, the format and content requirements 
for OTC drug product labeling under Sec.  201.66. Labeling created to 
satisfy the requirements in Sec.  201.66 is commonly referred to as the 
DFL. The DFL is intended to help enable consumers to appropriately 
self-select and use the nonprescription drug product safely and 
effectively.
    FDA has received a number of inquiries about: (1) Additional 
labeling, beyond the DFL, that FDA can approve for nonprescription drug 
products and (2) whether applications may be submitted for 
nonprescription drug products with one or more additional conditions 
that consumers must fulfill to ensure that the drug product is safe and 
effective for nonprescription use.
    FDA is issuing this draft guidance to describe two innovative 
approaches to consider that may be useful for demonstrating safety and 
effectiveness for a nonprescription drug product in cases where the DFL 
alone is not sufficient to ensure that the drug product can be used 
safely and effectively in a nonprescription setting: (1) The 
development of labeling in addition to the DFL and (2) the 
implementation of additional conditions so that consumers appropriately 
self-select and use the product. The appropriateness and specific 
details of either of these approaches will depend on the circumstances 
that apply to a particular drug product. FDA believes the innovative 
approaches described in this draft guidance could lead to the approval 
of a wider range of nonprescription drug products. FDA currently 
intends to issue a proposed rule that provides more details regarding 
the use of additional conditions for nonprescription drug products.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Innovative 
Approaches for Nonprescription Drug Products.'' It does not establish 
any rights for any person and is not binding on FDA or the public. You 
can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations. This guidance is not subject to 
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The submission of NDAs under 21 CFR 314.50 to market 
nonprescription drug products has been approved by OMB under control 
number 0910-0001. In addition, OTC Drug Facts Labeling requirements 
under Sec.  201.66 have been approved under OMB control number 0910-
0340.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: July 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15296 Filed 7-17-18; 8:45 am]
 BILLING CODE 4164-01-P