[Federal Register Volume 84, Number 133 (Thursday, July 11, 2019)]
[Notices]
[Pages 33073-33075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14781]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1768]


Harmonizing Compendial Standards With Drug Application Approval 
Using the United States Pharmacopeial Convention Pending Monograph 
Process; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled 
``Harmonizing Compendial Standards with Drug Application Approval Using 
the USP Pending Monograph Process.'' This guidance assists applicants 
(or drug substance master file (MF) holders referenced in an 
application) in the

[[Page 33074]]

initiation of either revisions to an existing monograph(s) or 
development of a new monograph(s) under the United States Pharmacopeial 
Convention Pending Monograph Process (USP-PMP) during FDA's evaluation 
of a drug substance master file or drug product application. This 
guidance describes the process that allows for the revision of 
compendial standards that are harmonized with the approved quality and 
labeling requirements for a drug product application.

DATES: Submit either electronic or written comments on the draft 
guidance by September 9, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2019-D-1768 for ``Harmonizing Compendial Standards With Drug 
Application Approval Using the USP Pending Monograph Process.'' 
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; or Policy 
and Regulations Staff, HFV-6, Center for Veterinary Medicine, Food and 
Drug Administration, 7500 Standish Pl., Rockville, MD 20855. 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: Lana Bruney, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4157, Silver Spring, MD 20993-0002, 240-
402-3462; or Mai Huynh, Center for Veterinary Medicine, Food and Drug 
Administration, 7500 Standish Pl., Rm. E337, Rockville, MD 20855, 240-
402-0669.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Harmonizing Compendial Standards With Drug Application 
Approval Using the USP Pending Monograph Process.'' As part of the 
reauthorization of the Generic Drug User Fee Amendments (GDUFA II), FDA 
recommitted to promoting the efficiency and effectiveness of the 
application review process. Part of the application approval process 
includes compliance with the official compendium, the USP-NF (National 
Formulary), if applicable. This guidance assists applicants in the 
initiation of either revisions to an existing monograph(s) or 
development of a new monograph(s) under the USP-PMP during FDA's 
evaluation of a drug substance MF or drug product application.
    A drug with a name recognized in the USP-NF must comply with 
compendial identity standards or the drug will be deemed adulterated, 
misbranded, or both (see section 501(b) and 502(e)(3)(b) and (g) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(b) and 
352(e)(3)(b) and (g)); and Sec.  299.5(a) and (b) (21 CFR 299.5(a) and 
(b))). Such drugs must also comply with compendial standards for 
strength, quality, and purity, unless labeled to show all respects in 
which the drug differs, or they will be deemed adulterated (see section 
501(b) of the FD&C Act and Sec.  299.5(c)). Before USP-PMP launched, if 
during the review of a new drug application (NDA), an abbreviated new 
drug application (ANDA), a new animal drug application (NADA), or an 
abbreviated new animal drug application (ANADA), it was clear that the 
proposed specifications would not comply with the current

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monograph, approval of the application and patient access to the drug 
were delayed because the USP-NF standards development processes did not 
accept proposals from applicants requesting changes to compendial 
standards for products that were not currently approved by FDA. If a 
monograph needed to be revised to include the applicant's proposed 
specifications, there were no mechanisms to do this until after the 
application was approved. For approval, the product would have to be 
shown to meet the current monograph, at least for identity, and the 
product label would have to indicate differences from the monograph 
regarding strength, quality, or purity. Typically, the revised 
monograph would not become official for 6 months or more. The USP-PMP 
was created to address these issues.
    Under the USP-PMP, applicants that have successfully filed an NDA, 
ANDA, NADA, or ANADA with FDA and are awaiting review and approval can 
propose revisions to an existing monograph or can propose the 
publication of a new monograph for an article that is not currently 
part of the official compendia. MF holders referenced in a successfully 
filed NDA, ANDA, NADA, or ANADA may also propose revisions to an 
existing monograph or propose publication of a new monograph for their 
drug substance. Immediately following FDA approval of a specific NDA, 
ANDA, NADA, or ANADA, USP will make available a revised monograph (or 
new monograph, as applicable) harmonized with the application's 
approved quality specifications. This process results in the creation 
of compendial standards that are harmonized with the quality 
specifications in an approved application. (Note: Initiation of the 
USP-PMP does not confer Agency acceptability of the compendial 
standards proposed for the product, nor preclude full application 
evaluation by the Agency; all applications will be subject to complete 
evaluation using current established review practices.)
    This guidance details the Agency's expectations for applicants (and 
MF holders referenced by applications awaiting approval) who choose to 
use the USP-PMP. The document explains how applicants (and MF holders) 
should initiate the process, provides Agency recommendations, and 
addresses some common situations that may arise during use of the USP-
PMP.
    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 ``Harmonizing 
Compendial Standards With Drug Application Approval Using the USP 
Pending Monograph Process.'' 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 collections of information relating to NDAs and ANDAs in 21 
CFR part 314, including 21 CFR 314.50, 314.94, and 314.420, have been 
approved under OMB control number 0910-0001. The collections of 
information relating to NADAs in 21 CFR part 514, including 21 CFR 
514.1, 514.4, 514.5, 514.6, 514.8, 514.11, and 558.5 have been approved 
under OMB control number 0910-0032. The collections of information 
relating to ANADAs in sections 512(b)(2) and (n)(1) of the FD&C Act (21 
U.S.C. 360b(b)(2) and (n)(1)) have been approved under OMB control 
number 0910-0669.

III. Electronic Access

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

    Dated: July 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14781 Filed 7-10-19; 8:45 am]
 BILLING CODE 4164-01-P