Document ID: FDA-2018-D-1635-0001
Agency: fda
Document Type: Notice
Title: Prescription Drug User Fee Act Waivers for Fixed-Combination  Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief; Draft Guidance for Industry; Availability
Posted Date: 2018-06-07T04:00Z

[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26475-26477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12217]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1635]

Prescription Drug User Fee Act Waivers for Fixed-Combination 
Antiretroviral Drugs for the President's Emergency Plan for AIDS 
Relief; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Prescription Drug User Fee Act Waivers for Fixed-Combination 
Antiretroviral Drugs for the President's Emergency Plan for AIDS 
Relief.'' This draft guidance describes circumstances under which an 
applicant may be eligible for a barrier-to-innovation waiver for some 
new drug applications (NDAs) for fixed-combination versions and single-
entity versions of previously approved antiretroviral therapies for the 
treatment of human immunodeficiency virus (HIV).

DATES: Submit either electronic or written comments on the guidance 
August 6, 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draft guidance before it begins work on the final version of the 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

[[Page 26476]]

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-1635 for ``Prescription Drug User Fee Act Waivers for Fixed-
Combination Antiretroviral Drugs for the President's Emergency Plan for 
AIDS Relief.'' 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: Ted Palat, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Rm. 2185, Silver Spring, MD 20993, 240-402-8739, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Prescription Drug User Fee Act Waivers for Fixed-Combination 
Antiretroviral Drugs for the President's Emergency Plan for AIDS 
Relief.'' The draft guidance describes the circumstances under which 
certain applications for fixed-combination and single-entity versions 
of previously approved antiretroviral therapies for the treatment of 
HIV under the President's Emergency Plan for AIDS Relief (PEPFAR) may 
be eligible for a barrier-to-innovation waiver.
    In October 2006, to encourage applicants to submit applications for 
HIV combination therapies that can be used in PEPFAR, FDA issued a 
final guidance entitled ``Fixed Dose Combinations, Co-Packaged Drug 
Products, and Single-Entity Versions of Previously Approved 
Antiretrovirals for the Treatment of HIV'' (fixed-combination 
guidance). Attachments to the fixed-combination guidance describe some 
scenarios for approval of fixed-combination for the treatment of HIV 
and provide examples of drug combinations considered acceptable as 
fixed combinations and examples of those not considered acceptable as 
fixed combinations. Although the 2006 fixed-combination guidance 
focuses on fixed combinations, the scientific principles outlined in 
the guidance also apply to single ingredient versions of antiretroviral 
drugs that are components of regimens listed in Attachment B. The 
guidance also explains that the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) provides for certain circumstances in which FDA may grant a 
waiver or reduction in user fees.
    This draft guidance is a revision of the guidance for industry 
entitled ``User Fee Waivers for FDC and Co-Packaged HIV Drugs for 
PEPFAR,'' issued February 2007. In this guidance, FDA provides 
information about the circumstances under which certain applications 
for fixed-combination and single-entity versions of previously approved 
antiretroviral therapies for the treatment of HIV under PEPFAR may be 
eligible for a barrier-to-innovation waiver.
    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 ``Prescription 
Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs 
for the President's Emergency Plan for AIDS Relief.'' 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 contains information collection provisions 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 
burden of information collection associated with requesting waivers of 
user fees (including PEPFAR waivers) was previously approved under OMB 
control number 0910-0693. The burden for completing and submitting Form 
FDA 3397 (Prescription Drug User Fee Coversheet) is not included in 
this analysis as the burden is already approved under OMB control 
number 0910-0297. The collections of information associated with 
submission of a new drug application or biologics license application 
are approved under OMB control numbers 0910-0001 and 0910-0338, 
respectively.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/

[[Page 26477]]

GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12217 Filed 6-6-18; 8:45 am]
BILLING CODE 4164-01-P