Harmonizing Compendial Standards With Drug Application Approval Using the United States Pharmacopeial Convention Pending Monograph Process; Draft Guidance for Industry; Availability, 33073-33075 [2019-14781]
Download as PDF
<![CDATA[
33073
Federal Register / Vol. 84, No. 133 / Thursday, July 11, 2019 / Notices
insurance cost sharing collection, and
307 additional hours due to the pilot
test on sampling NHIS nonrespondents
account for the difference. While the
burden associated with these added
tasks totals 7,602 hours, reductions in
other burden estimates leave a net
difference of 7,264 hours overall.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Total burden
hours
Average
hourly wage
rate
Total cost
burden
MEPS–HC
MEPS–HC Core Interview ...............................................................................
Adult Female SAQ (PSAQ)–Years 2019 and 2021; Adult SAQ (SAQ)—Year
2020 .............................................................................................................
Adult Male SAQ (PSAQ)—Years 2019 and 2021; Adult SAQ (SAQ) -Year
2020 .............................................................................................................
Diabetes care SAQ ..........................................................................................
Mental Health Questions Included in Adult SAQ (Male/Female)—Year 2020
Authorization forms for the MEPS–MPC Provider Survey ..............................
Authorization form for the MEPS–MPC Pharmacy Survey .............................
Health Insurance Cost Sharing Collection—2020 ...........................................
MEPS–HC Validation Interview .......................................................................
Pilot Test on Sampling NHIS Nonrespondents—2020 ....................................
* 13,338
51,129
* $24.34
$1,244,479
12,984
1,515
* 24.34
36,875
11,985
2,072
20,476
12,804
12,804
6,258
4,225
200
1,398
104
1,194
3,457
1,985
6,101
352
307
* 24.34
* 24.34
* 24.34
* 24.34
* 24.34
* 24.34
* 24.34
* 24.34
34,027
2,531
29,062
84,143
48,314
148,498
8,567
7,472
Subtotal for the MEPS–HC .......................................................................
102,366
67,542
na
1,643,968
MPC Contact Guide/Screening Call ................................................................
Home care for health care providers questionnaire ........................................
Home care for non-health care providers questionnaire .................................
Office-based providers questionnaire ..............................................................
Separately billing doctors questionnaire ..........................................................
Hospitals questionnaire ...................................................................................
Institutions (non-hospital) questionnaire ..........................................................
Pharmacies questionnaire ...............................................................................
36,598
635
11
11,210
12,397
5,310
116
6,919
1,220
146
2
3,083
9,294
2,597
36
1,010
** 17.25
** 17.25
** 17.25
** 17.25
** 17.25
** 17.25
** 17.25
*** 15.90
21,045
2,519
35
53,182
160,322
44,798
621
16,059
Subtotal for the MEPS–MPC ....................................................................
73,196
17,388
na
298,580
Grand Total .......................................................................................
175,562
na
na
1,942,548
MEPS–MPC
* Mean hourly wage for All Occupations (00–0000).
** Mean hourly wage for Medical Secretaries (43–6013).
*** Mean hourly wage for Pharmacy Technicians (29–2052).
jspears on DSK30JT082PROD with NOTICES
Occupational Employment Statistics,
May 2017 National Occupational
Employment and Wage Estimates
United States, U.S. Department of Labor,
Bureau of Labor Statistics.
Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ’s health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
VerDate Sep<11>2014
17:26 Jul 10, 2019
Jkt 247001
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: July 8, 2019.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019–14770 Filed 7–10–19; 8:45 am]
BILLING CODE 4160–90–P
PO 00000
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.
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
SUMMARY:
Frm 00023
Fmt 4703
Sfmt 4703
E:\FR\FM\11JYN1.SGM
11JYN1
33074
Federal Register / Vol. 84, No. 133 / Thursday, July 11, 2019 / Notices
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:
jspears on DSK30JT082PROD with NOTICES
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.’’
VerDate Sep<11>2014
17:26 Jul 10, 2019
Jkt 247001
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/201523389.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,
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
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
§ 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 § 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
E:\FR\FM\11JYN1.SGM
11JYN1
jspears on DSK30JT082PROD with NOTICES
Federal Register / Vol. 84, No. 133 / Thursday, July 11, 2019 / Notices
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
VerDate Sep<11>2014
17:26 Jul 10, 2019
Jkt 247001
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/
GuidanceComplianceRegulatory
Information/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0331]
Live Case Presentations During
Investigational Device Exemption
Clinical Trials; Guidance for
Institutional Review Boards, Industry,
Clinical Investigators, and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
ACTION:
33075
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Live Case
Presentations During Investigational
Device Exemption (IDE) Clinical Trials.’’
The purpose of this guidance is to
provide institutional review boards
(IRBs), industry, clinical investigators,
and FDA staff with factors to consider
when evaluating the appropriateness of
a live case presentation within a clinical
investigation conducted under an
investigational device exemption (IDE)
application. This document provides
guidance on important information
about a live case presentation that
should be provided as part of an original
IDE application or a supplement to an
IDE application when requesting
inclusion of a live case presentation
during a clinical investigation.
DATES: The announcement of the
guidance is published in the Federal
Register on July 11, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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
E:\FR\FM\11JYN1.SGM
11JYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 33075]]
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
