Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request, 66995-66999 [2020-23290]
Download as PDF
<![CDATA[
66995
Federal Register / Vol. 85, No. 204 / Wednesday, October 21, 2020 / Notices
Application No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
NDA 021909 .........
NDA 022291 .........
NDA 022362 .........
PROMACTA .............
WELCHOL ................
EQ 100 mg Acid ..............
1.875 g/Packet ................
Tablet, Orally Disintegrating; Oral.
Tablet, Orally Disintegrating; Oral.
Tablet; Oral ...............
For Suspension; Oral
Sanofi-Aventis U.S.,
LLC.
Bausch Health US,
LLC.
Novartis.
Daiichi Sankyo.
NDA 022396 .........
DYLOJECT ...............
Fexofenadine Hydrochloride.
Metoclopramide Hydrochloride.
Eltrombopag Olamine
Colesevelam Hydrochloride.
Diclofenac Sodium ....
30 mg ..............................
NDA 022246 .........
CHILDREN’S
ALLEGRA HIVES.
METOZOLV ODT .....
37.5 mg/mL (37.5 mg/mL)
Solution; Intravenous
NDA 050368 .........
NDA 050587 .........
ILOTYCIN .................
PRIMAXIN ................
Ointment; Ophthalmic
Powder; Intravenous
NDA 201373 .........
CHILDREN’S
ALLEGRA HIVES.
NARCAN ...................
0.5% ................................
EQ 250 mg Base/Vial;
250 mg/Vial.
30 mg/5 mL .....................
Javelin Pharmaceuticals, Inc.
Eli Lilly and Co.
Merck & Co., Inc.
2 mg/Spray ......................
Spray, Metered;
Nasal.
NDA 208411 .........
Erythromycin .............
Cilastatin Sodium;
Imipenem.
Fexofenadine Hydrochloride.
Naloxone Hydrochloride.
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed were not
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
Agency will continue to list the drug
products in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
NDAs and ANDAs listed are unaffected
by the discontinued marketing of the
products subject to those NDAs and
ANDAs. Additional ANDAs that refer to
these products may also be approved by
the Agency if they comply with relevant
legal and regulatory requirements. If
FDA determines that labeling for these
drug products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: October 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–23300 Filed 10–20–20; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:58 Oct 20, 2020
Jkt 253001
EQ 5 mg Base ................
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3771]
Annual Status Report Information and
Other Submissions for Postmarketing
Requirements and Commitments:
Using Forms FDA 3988 and FDA 3989;
Draft Guidance for Industry;
Availability; Agency Information
Collection Activities; Proposed
Collection; Comment Request
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 ‘‘Annual
Status Report Information and Other
Submissions for Postmarketing
Requirements and Commitments: Using
Forms FDA 3988 and FDA 3989.’’ Forms
FDA 3988, Transmittal of PMR/PMC
Submissions for Drugs and Biologics,
and FDA 3989, PMR/PMC Annual
Status Report for Drugs and Biologics,
are intended to facilitate submissions by
drug and biological product application
holders of complete and accurate
information on postmarketing
requirements (PMRs) and postmarketing
commitments (PMCs) in a consistent
format. Forms FDA 3988 and 3989 are
published in draft form in Appendix A
and B of the draft guidance for comment
and are not intended to be used until
the forms are finalized. The forms were
developed, in part, in response to the
recommendations from the Government
Accountability Office (GAO) and the
Department of Health and Human
Services (HHS) Office of the Inspector
General (OIG) regarding the need for
comparable information across annual
status reports (ASRs) on PMRs and
SUMMARY:
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
Suspension; Oral ......
Applicant
Sanofi-Aventis U.S.,
LLC.
Adapt Pharma.
PMCs, to eliminate manual data entry,
and to enhance FDA’s ability to track
PMRs and PMCs. These forms are
expected to result in improved accuracy
and timeliness of FDA’s identification
and review of those submissions
containing information on PMRs and
PMCs. This draft guidance covers the
purpose of each form, when to use these
forms, and how to submit these forms.
The draft guidance also explains where
applicants will be able to find the forms
and instructions for their completion
once the forms and instructions are
finalized.
Submit either electronic or
written comments on the draft guidance
by December 21, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
Submit either electronic or written
comments on the collection of
information set forth in this document
by December 21, 2020.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:
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
E:\FR\FM\21OCN1.SGM
21OCN1
66996
Federal Register / Vol. 85, No. 204 / Wednesday, October 21, 2020 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
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
should include the Docket No. FDA–
2018–N–3771 for ‘‘Annual Status Report
Information and Other Submissions for
Postmarketing Requirements and
Commitments: Using Forms FDA 3988
and FDA 3989.’’ 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
VerDate Sep<11>2014
16:58 Oct 20, 2020
Jkt 253001
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.govinfo.gov/content/pkg/FR-201509-18/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 the Office of Communication,
Outreach, and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, 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:
Kathy Weil, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5367, Silver Spring,
MD 20993–0002, 301–796–6054; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
With regard to the proposed collection
of information: Domini Bean, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
5733, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Annual Status Report Information and
Other Submissions for Postmarketing
Requirements and Commitments: Using
Forms FDA 3988 and FDA 3989.’’ This
draft guidance is intended for applicants
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
that are required to report annually on
the status of postmarketing studies and
clinical trials for human drug and
biological products under section 506B
of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 356b) and its
implementing regulations at
§§ 314.81(b)(2)(vii) and 601.70 (21 CFR
314.81(b)(2)(vii) and 601.70). These
forms are expected to result in improved
accuracy and timeliness of FDA’s
identification and review of those
submissions containing information on
PMRs and PMCs. The purpose of the
draft guidance is to explain why Forms
FDA 3988 and FDA 3989 were created,
describe the contents of the forms, and
explain how to submit the forms
electronically. The draft guidance also
explains where applicants will be able
to find the forms and instructions for
their completion once the forms and
instructions are finalized. Forms FDA
3988 and 3989 are published in draft
form in Appendix A and B of the draft
guidance for comment and are not
intended to be used until the forms are
finalized.
PMRs and PMCs are studies or
clinical trials conducted by the
applicant after FDA has approved a drug
or biological product for marketing or
licensing. These studies or clinical trials
can be required under statute or
regulation (PMRs) or agreed upon in
writing by FDA and the applicant
(PMCs). Section 130(a) of the Food and
Drug Administration Modernization Act
of 1997 amended the FD&C Act by
adding section 506B of the FD&C Act
(21 U.S.C. 356b). Under section 506B of
the FD&C Act and its implementing
regulations at §§ 314.81(b)(2)(vii) and
601.70, applicants must submit an ASR
on PMRs and PMCs.1 This report must
address the progress of the PMR/PMC or
the reasons for failing to conduct the
requirement or commitment (section
506B(a) of the FD&C Act).
This draft guidance does not apply to
postmarketing studies or clinical trials
1 The FDA defines postmarketing studies or
clinical trials for which annual status reports
(ASRs) must be submitted under section 506B of the
FD&C Act as those concerning a human drug or
biological product’s clinical safety, clinical efficacy,
clinical pharmacology, or nonclinical toxicology
that are either required by FDA (PMRs) or that are
committed to, in writing, (PMCs) either at the time
of approval of an application or a supplement or
after approval of an application or supplement. See
§§ 314.81(b)(2)(vii) and 601.70. FDA interprets
section 506B of the FD&C Act to apply to
postmarketing studies and clinical trials that are
required under the Pediatric Research Equity Act
(section 505B of the FD&C Act (21 U.S.C. 355c);
§§ 314.55(b) and 601.27(b)), the animal efficacy rule
(§§ 314.610(b)(1) and 601.91(b)(1)), accelerated
approval (section 506(c)(2)(A) of the FD&C Act;
§§ 314.510 and 601.41), and the Food and Drug
Administration Amendments Act of 2007 (section
505(o)(3) of the FD&C Act (21 U.S.C. 355(o)(3)).
E:\FR\FM\21OCN1.SGM
21OCN1
Federal Register / Vol. 85, No. 204 / Wednesday, October 21, 2020 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
that are not subject to the reporting
requirements of section 506B of the
FD&C Act.2 For example, the draft
guidance does not apply to voluntary
studies or clinical trials performed by an
applicant or on an applicant’s behalf
that are neither required nor agreed
upon in writing. This draft guidance
also does not apply to PMCs related to
chemistry, manufacturing, and controls
or stability studies.
In a December 2015 report from the
GAO entitled ‘‘Drug Safety: FDA
Expedites Many Applications, but Data
for Postapproval Oversight Need
Improvement,’’ 3 the GAO
recommended that FDA improve its
data tracking to ensure the
completeness, timeliness, and accuracy
of information in its database on PMRs/
PMCs. Additionally, in a July 2016 HHS
OIG study entitled ‘‘FDA is Issuing
More Postmarketing Requirements, but
Challenges with Oversight Persist,’’ 4 the
HHS OIG noted that FDA continued to
have problems with its data
management system and work
processes, thereby hindering its ability
to track PMRs. OIG recommended that
FDA provide standardized forms for
ASRs, ensure that the forms are
complete, and require applicants to
submit the forms electronically.
Based in part on the
recommendations from GAO and HHS
OIG, FDA created Forms FDA 3988 and
FDA 3989 to improve its collection,
identification, and use of information
regarding PMRs and PMCs. Form FDA
3988 was developed to accompany an
applicant’s PMR/PMC-related
submissions (e.g., draft protocols, final
protocols, interim reports, final reports,
and PMR/PMC-related correspondence),
except the ASR on PMRs and PMCs.
Form FDA 3988 allows applicants to
identify, in a standardized format, the
type of PMR/PMC-related submission
the applicant is making (e.g., draft
protocol) and the PMR or PMC to which
the submission applies. Form FDA 3989
was developed so that applicants may
provide ASR information on their PMRs
and PMCs in a standardized format. The
purpose of these forms is to assist
applicants in providing clearly
identified PMR/PMC-related
submissions and in meeting their
annual reporting requirements under
2 Under § 314.81(b)(2)(viii), applicants submitting
an annual report for human drug products must
include a status report of postmarketing studies and
clinical trials not included under § 314.81(b)(2)(vii)
that are being performed by, or on behalf of, the
applicant.
3 Available at https://www.gao.gov/products/
GAO-16-192.
4 Available at https://oig.hhs.gov/oei/reports/oei01-14-00390.asp.
VerDate Sep<11>2014
16:58 Oct 20, 2020
Jkt 253001
section 506B of the FD&C Act and
§§ 314.81(b)(2)(vii) and 601.70.
Use of Form FDA 3988 and 3989 is
optional, but FDA encourages their use
because the forms should facilitate FDA
management and review of the
applicant’s submissions, as well as
enhance the accuracy of data within
FDA’s electronic document archiving
systems. FDA uses these archiving
systems as a source from which to
obtain data published annually in the
Federal Register as required under
section 506B(c) of the FD&C Act and to
provide quarterly status updates of the
PMR and PMC data on FDA’s
Postmarket Requirements and
Commitments public web page
(available at https://
www.accessdata.fda.gov/scripts/cder/
pmc/index.cfm).
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 ‘‘Annual Status Report Information
and Other Submissions for
Postmarketing Requirements and
Commitments: Using Forms FDA 3988
and FDA 3989.’’ 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.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
3521), 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
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
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
66997
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.
Annual Status Report Information and
Other Submissions for Postmarketing
Requirements and Commitments: Using
Forms FDA 3988 and FDA 3989
The draft guidance describes the
purpose and content of Form FDA 3988,
Transmittal of PMR/PMC Submissions
for Drugs and Biologics, and Form FDA
3989, PMR/PMC Annual Status Report
for Drugs and Biologics. These forms are
intended for applicants that are required
by statute or regulation, or that have
agreed in writing, to conduct
postmarketing studies or clinical trials
concerning the clinical safety, clinical
efficacy, clinical pharmacology, or
nonclinical toxicology of a human drug
or biological product as PMRs or PMCs.
Applicants are required to submit ASRs
on PMCs and PMRs under section 506B
of the FD&C Act and its implementing
regulations at §§ 314.81(b)(2)(vii) and
601.70, and this information collection
is approved under OMB control
numbers 0910–0001 and 0910–0338,
respectively. For this reason, these
existing control numbers will be
updated to account for Forms FDA 3988
and FDA 3989.
Form FDA 3988 would include the
following information:
• Applicant’s name, Center that
approved or licensed the application
(Center for Drug Evaluation and
Research or Center for Biologics
Evaluation and Research), application
type (new drug application (NDA),
biologics license application (BLA),
abbreviated new drug application
(ANDA), or investigational new drug
application (IND)), and submission date.
• Six-digit application number and
supplement number(s) as applicable.
• Drug or biologic product’s
established name (e.g., proper name,
U.S. Pharmacopeia/U.S. Adopted Name)
and proprietary (trade) name(s), if any.
• Information for all PMRs and PMCs
addressed in the submission, including
type (PMR or PMC), PMR or PMC
number, establishment date, and
National Clinical Trial (NCT) number (if
applicable).
• PMR/PMC submission type,
including draft protocol, final protocol,
interim report, final report, general
correspondence, Pediatric Research
E:\FR\FM\21OCN1.SGM
21OCN1
66998
Federal Register / Vol. 85, No. 204 / Wednesday, October 21, 2020 / Notices
Equity Act PMR deferral extension
request, response to information
request, request for revised milestones,
and ‘‘other,’’ and a brief description of
the submission’s content or rationale.
• Name and title of the applicant’s
Responsible Official, and (as applicable)
telephone and facsimile numbers, and
email and mailing addresses.
• Signature of the applicant’s
Responsible Official or other Authorized
Official, countersignature of the
Authorized U.S. Agent, and date that
the form is signed.
Form FDA 3989 would include the
following information:
• Applicant’s name, Center that
approved or licensed the application,
application type, and submission date.
• Six-digit application number and
date of U.S. approval.
• Drug or biologic product’s
established name (e.g., proper name,
U.S. Pharmacopeia/U.S. Adopted Name)
and proprietary (trade) name(s), if any.
• Alternate annual status report due
date (i.e., a date other than the approval
date that FDA has allowed the applicant
to use for annual reporting).
• Period covered by the report.
• PMR/PMC update for each ‘‘Open’’
PMR/PMC. Information includes PMR/
PMC number, establishment date,
supplement number as applicable,
description, study or clinical trial title
as applicable, current and expected
enrollment of studies and clinical trials
as applicable, study or clinical trial
status, explanation of status, and
milestone information (e.g., milestone
type, original date, revised date as
applicable, the reason for the revision).
• Name and title of the applicant’s
Responsible Official, and (as applicable)
telephone and facsimile numbers, and
email and mailing addresses.
• Signature of the applicant’s
Responsible Official or other Authorized
Official, countersignature of the
Authorized U.S. Agent, and date that
the form is signed.
Forms FDA 3988 and FDA 3989 are
fillable forms supporting electronic
signatures. Based on the number of
applicants required by statute or
regulation, or that have agreed in
writing, to conduct postmarketing
studies or clinical trials as PMRs or
PMCs, and based on the number of
PMR/PMC-related submissions that we
currently receive annually, we estimate
receiving approximately 1,908 Forms
FDA 3988 and 636 Forms FDA 3989,
annually, in accordance with the
description in the draft guidance. We
estimate that approximately 318 5
applicants will submit these forms, and
that each form, as described in the draft
guidance, will take approximately 1
hour to prepare and electronically
submit to FDA.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED REPORTING BURDEN 1 2 3
Number of
respondents
§ 314.81
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Form FDA 3988 ...................................................................
Form FDA 3989 ...................................................................
226
226
6
2
1,356
452
1
1
1,356
452
Total ..............................................................................
........................
........................
........................
........................
1,808
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
hours for Form FDA 3989 in this table includes and replaces the burden that applicants currently incur to complete the ASR on PMRs
and PMCs that is currently submitted as part of the annual report under § 314.81(b)(2).
3 Burden associated with OMB Control No. 0910–0001: Applications for FDA Approval to Market a New Drug.
2 Total
TABLE 2—ESTIMATED REPORTING BURDEN 1 2 3
Number of
respondents
§ 601.70
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Form FDA 3988 ...................................................................
Form FDA 3989 ...................................................................
92
92
6
2
552
184
1
1
552
184
Total ..............................................................................
........................
........................
........................
........................
736
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
hours for Form FDA 3989 in this table includes and replaces the burden that applicants currently incur to complete the ASR on PMRs
and PMCs that is currently submitted pursuant to § 601.70.
3 Burden associated with OMB Control No. 0910–0338: General Licensing Provisions: Biologics License Application, Changes to an Approved
Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h (21 CFR part 601).
khammond on DSKJM1Z7X2PROD with NOTICES
2 Total
5 This number is based on information from ‘‘The
Food and Drug Administration Report on the
VerDate Sep<11>2014
16:58 Oct 20, 2020
Jkt 253001
Performance of Drugs and Biologics Firms in
Conducting Postmarketing Requirements and
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
Commitments. Fiscal Year 2018’’ available at
https://www.fda.gov/media/129657/download.
E:\FR\FM\21OCN1.SGM
21OCN1
Federal Register / Vol. 85, No. 204 / Wednesday, October 21, 2020 / Notices
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, or https://
www.regulations.gov.
Dated: October 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–23290 Filed 10–20–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0781]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Record Retention
Requirements for the Soy Protein and
Risk of Coronary Heart Disease Health
Claim
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, we, or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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 record
retention requirement of the soy
protein/coronary heart disease health
claim.
DATES: Submit either electronic or
written comments on the collection of
information by December 21, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before December 21,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 21, 2020.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:58 Oct 20, 2020
Jkt 253001
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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–
2011–N–0781 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Record
Retention Requirements for the Soy
Protein and Risk of Coronary Heart
Disease Health Claim.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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, 240–420–7500.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
66999
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–420–7500.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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
E:\FR\FM\21OCN1.SGM
21OCN1
]]>Agencies
[Federal Register Volume 85, Number 204 (Wednesday, October 21, 2020)]
[Notices]
[Pages 66995-66999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23290]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3771]
Annual Status Report Information and Other Submissions for
Postmarketing Requirements and Commitments: Using Forms FDA 3988 and
FDA 3989; Draft Guidance for Industry; Availability; Agency Information
Collection Activities; Proposed Collection; Comment Request
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 ``Annual
Status Report Information and Other Submissions for Postmarketing
Requirements and Commitments: Using Forms FDA 3988 and FDA 3989.''
Forms FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and
Biologics, and FDA 3989, PMR/PMC Annual Status Report for Drugs and
Biologics, are intended to facilitate submissions by drug and
biological product application holders of complete and accurate
information on postmarketing requirements (PMRs) and postmarketing
commitments (PMCs) in a consistent format. Forms FDA 3988 and 3989 are
published in draft form in Appendix A and B of the draft guidance for
comment and are not intended to be used until the forms are finalized.
The forms were developed, in part, in response to the recommendations
from the Government Accountability Office (GAO) and the Department of
Health and Human Services (HHS) Office of the Inspector General (OIG)
regarding the need for comparable information across annual status
reports (ASRs) on PMRs and PMCs, to eliminate manual data entry, and to
enhance FDA's ability to track PMRs and PMCs. These forms are expected
to result in improved accuracy and timeliness of FDA's identification
and review of those submissions containing information on PMRs and
PMCs. This draft guidance covers the purpose of each form, when to use
these forms, and how to submit these forms. The draft guidance also
explains where applicants will be able to find the forms and
instructions for their completion once the forms and instructions are
finalized.
DATES: Submit either electronic or written comments on the draft
guidance by December 21, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit either electronic or written comments
on the collection of information set forth in this document by December
21, 2020.
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
[[Page 66996]]
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 should include the Docket
No. FDA-2018-N-3771 for ``Annual Status Report Information and Other
Submissions for Postmarketing Requirements and Commitments: Using Forms
FDA 3988 and FDA 3989.'' 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.govinfo.gov/content/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 the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, 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: Kathy Weil, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5367, Silver Spring, MD 20993-0002, 301-796-6054; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 240-402-7911.
With regard to the proposed collection of information: Domini Bean,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733, PRAS[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Annual Status Report Information and Other Submissions for
Postmarketing Requirements and Commitments: Using Forms FDA 3988 and
FDA 3989.'' This draft guidance is intended for applicants that are
required to report annually on the status of postmarketing studies and
clinical trials for human drug and biological products under section
506B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
356b) and its implementing regulations at Sec. Sec. 314.81(b)(2)(vii)
and 601.70 (21 CFR 314.81(b)(2)(vii) and 601.70). These forms are
expected to result in improved accuracy and timeliness of FDA's
identification and review of those submissions containing information
on PMRs and PMCs. The purpose of the draft guidance is to explain why
Forms FDA 3988 and FDA 3989 were created, describe the contents of the
forms, and explain how to submit the forms electronically. The draft
guidance also explains where applicants will be able to find the forms
and instructions for their completion once the forms and instructions
are finalized. Forms FDA 3988 and 3989 are published in draft form in
Appendix A and B of the draft guidance for comment and are not intended
to be used until the forms are finalized.
PMRs and PMCs are studies or clinical trials conducted by the
applicant after FDA has approved a drug or biological product for
marketing or licensing. These studies or clinical trials can be
required under statute or regulation (PMRs) or agreed upon in writing
by FDA and the applicant (PMCs). Section 130(a) of the Food and Drug
Administration Modernization Act of 1997 amended the FD&C Act by adding
section 506B of the FD&C Act (21 U.S.C. 356b). Under section 506B of
the FD&C Act and its implementing regulations at Sec. Sec.
314.81(b)(2)(vii) and 601.70, applicants must submit an ASR on PMRs and
PMCs.\1\ This report must address the progress of the PMR/PMC or the
reasons for failing to conduct the requirement or commitment (section
506B(a) of the FD&C Act).
---------------------------------------------------------------------------
\1\ The FDA defines postmarketing studies or clinical trials for
which annual status reports (ASRs) must be submitted under section
506B of the FD&C Act as those concerning a human drug or biological
product's clinical safety, clinical efficacy, clinical pharmacology,
or nonclinical toxicology that are either required by FDA (PMRs) or
that are committed to, in writing, (PMCs) either at the time of
approval of an application or a supplement or after approval of an
application or supplement. See Sec. Sec. 314.81(b)(2)(vii) and
601.70. FDA interprets section 506B of the FD&C Act to apply to
postmarketing studies and clinical trials that are required under
the Pediatric Research Equity Act (section 505B of the FD&C Act (21
U.S.C. 355c); Sec. Sec. 314.55(b) and 601.27(b)), the animal
efficacy rule (Sec. Sec. 314.610(b)(1) and 601.91(b)(1)),
accelerated approval (section 506(c)(2)(A) of the FD&C Act;
Sec. Sec. 314.510 and 601.41), and the Food and Drug Administration
Amendments Act of 2007 (section 505(o)(3) of the FD&C Act (21 U.S.C.
355(o)(3)).
---------------------------------------------------------------------------
This draft guidance does not apply to postmarketing studies or
clinical trials
[[Page 66997]]
that are not subject to the reporting requirements of section 506B of
the FD&C Act.\2\ For example, the draft guidance does not apply to
voluntary studies or clinical trials performed by an applicant or on an
applicant's behalf that are neither required nor agreed upon in
writing. This draft guidance also does not apply to PMCs related to
chemistry, manufacturing, and controls or stability studies.
---------------------------------------------------------------------------
\2\ Under Sec. 314.81(b)(2)(viii), applicants submitting an
annual report for human drug products must include a status report
of postmarketing studies and clinical trials not included under
Sec. 314.81(b)(2)(vii) that are being performed by, or on behalf
of, the applicant.
---------------------------------------------------------------------------
In a December 2015 report from the GAO entitled ``Drug Safety: FDA
Expedites Many Applications, but Data for Postapproval Oversight Need
Improvement,'' \3\ the GAO recommended that FDA improve its data
tracking to ensure the completeness, timeliness, and accuracy of
information in its database on PMRs/PMCs. Additionally, in a July 2016
HHS OIG study entitled ``FDA is Issuing More Postmarketing
Requirements, but Challenges with Oversight Persist,'' \4\ the HHS OIG
noted that FDA continued to have problems with its data management
system and work processes, thereby hindering its ability to track PMRs.
OIG recommended that FDA provide standardized forms for ASRs, ensure
that the forms are complete, and require applicants to submit the forms
electronically.
---------------------------------------------------------------------------
\3\ Available at https://www.gao.gov/products/GAO-16-192.
\4\ Available at https://oig.hhs.gov/oei/reports/oei-01-14-00390.asp.
---------------------------------------------------------------------------
Based in part on the recommendations from GAO and HHS OIG, FDA
created Forms FDA 3988 and FDA 3989 to improve its collection,
identification, and use of information regarding PMRs and PMCs. Form
FDA 3988 was developed to accompany an applicant's PMR/PMC-related
submissions (e.g., draft protocols, final protocols, interim reports,
final reports, and PMR/PMC-related correspondence), except the ASR on
PMRs and PMCs. Form FDA 3988 allows applicants to identify, in a
standardized format, the type of PMR/PMC-related submission the
applicant is making (e.g., draft protocol) and the PMR or PMC to which
the submission applies. Form FDA 3989 was developed so that applicants
may provide ASR information on their PMRs and PMCs in a standardized
format. The purpose of these forms is to assist applicants in providing
clearly identified PMR/PMC-related submissions and in meeting their
annual reporting requirements under section 506B of the FD&C Act and
Sec. Sec. 314.81(b)(2)(vii) and 601.70.
Use of Form FDA 3988 and 3989 is optional, but FDA encourages their
use because the forms should facilitate FDA management and review of
the applicant's submissions, as well as enhance the accuracy of data
within FDA's electronic document archiving systems. FDA uses these
archiving systems as a source from which to obtain data published
annually in the Federal Register as required under section 506B(c) of
the FD&C Act and to provide quarterly status updates of the PMR and PMC
data on FDA's Postmarket Requirements and Commitments public web page
(available at https://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm).
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 ``Annual
Status Report Information and Other Submissions for Postmarketing
Requirements and Commitments: Using Forms FDA 3988 and FDA 3989.'' 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.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3521), 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 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.
Annual Status Report Information and Other Submissions for
Postmarketing Requirements and Commitments: Using Forms FDA 3988 and
FDA 3989
The draft guidance describes the purpose and content of Form FDA
3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics, and
Form FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics.
These forms are intended for applicants that are required by statute or
regulation, or that have agreed in writing, to conduct postmarketing
studies or clinical trials concerning the clinical safety, clinical
efficacy, clinical pharmacology, or nonclinical toxicology of a human
drug or biological product as PMRs or PMCs. Applicants are required to
submit ASRs on PMCs and PMRs under section 506B of the FD&C Act and its
implementing regulations at Sec. Sec. 314.81(b)(2)(vii) and 601.70,
and this information collection is approved under OMB control numbers
0910-0001 and 0910-0338, respectively. For this reason, these existing
control numbers will be updated to account for Forms FDA 3988 and FDA
3989.
Form FDA 3988 would include the following information:
Applicant's name, Center that approved or licensed the
application (Center for Drug Evaluation and Research or Center for
Biologics Evaluation and Research), application type (new drug
application (NDA), biologics license application (BLA), abbreviated new
drug application (ANDA), or investigational new drug application
(IND)), and submission date.
Six-digit application number and supplement number(s) as
applicable.
Drug or biologic product's established name (e.g., proper
name, U.S. Pharmacopeia/U.S. Adopted Name) and proprietary (trade)
name(s), if any.
Information for all PMRs and PMCs addressed in the
submission, including type (PMR or PMC), PMR or PMC number,
establishment date, and National Clinical Trial (NCT) number (if
applicable).
PMR/PMC submission type, including draft protocol, final
protocol, interim report, final report, general correspondence,
Pediatric Research
[[Page 66998]]
Equity Act PMR deferral extension request, response to information
request, request for revised milestones, and ``other,'' and a brief
description of the submission's content or rationale.
Name and title of the applicant's Responsible Official,
and (as applicable) telephone and facsimile numbers, and email and
mailing addresses.
Signature of the applicant's Responsible Official or other
Authorized Official, countersignature of the Authorized U.S. Agent, and
date that the form is signed.
Form FDA 3989 would include the following information:
Applicant's name, Center that approved or licensed the
application, application type, and submission date.
Six-digit application number and date of U.S. approval.
Drug or biologic product's established name (e.g., proper
name, U.S. Pharmacopeia/U.S. Adopted Name) and proprietary (trade)
name(s), if any.
Alternate annual status report due date (i.e., a date
other than the approval date that FDA has allowed the applicant to use
for annual reporting).
Period covered by the report.
PMR/PMC update for each ``Open'' PMR/PMC. Information
includes PMR/PMC number, establishment date, supplement number as
applicable, description, study or clinical trial title as applicable,
current and expected enrollment of studies and clinical trials as
applicable, study or clinical trial status, explanation of status, and
milestone information (e.g., milestone type, original date, revised
date as applicable, the reason for the revision).
Name and title of the applicant's Responsible Official,
and (as applicable) telephone and facsimile numbers, and email and
mailing addresses.
Signature of the applicant's Responsible Official or other
Authorized Official, countersignature of the Authorized U.S. Agent, and
date that the form is signed.
Forms FDA 3988 and FDA 3989 are fillable forms supporting
electronic signatures. Based on the number of applicants required by
statute or regulation, or that have agreed in writing, to conduct
postmarketing studies or clinical trials as PMRs or PMCs, and based on
the number of PMR/PMC-related submissions that we currently receive
annually, we estimate receiving approximately 1,908 Forms FDA 3988 and
636 Forms FDA 3989, annually, in accordance with the description in the
draft guidance. We estimate that approximately 318 \5\ applicants will
submit these forms, and that each form, as described in the draft
guidance, will take approximately 1 hour to prepare and electronically
submit to FDA.
---------------------------------------------------------------------------
\5\ This number is based on information from ``The Food and Drug
Administration Report on the Performance of Drugs and Biologics
Firms in Conducting Postmarketing Requirements and Commitments.
Fiscal Year 2018'' available at https://www.fda.gov/media/129657/download.
---------------------------------------------------------------------------
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Reporting Burden \1\ \2\ \3\
----------------------------------------------------------------------------------------------------------------
Number of
Sec. 314.81 Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Form FDA 3988................... 226 6 1,356 1 1,356
Form FDA 3989................... 226 2 452 1 452
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,808
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Total hours for Form FDA 3989 in this table includes and replaces the burden that applicants currently incur
to complete the ASR on PMRs and PMCs that is currently submitted as part of the annual report under Sec.
314.81(b)(2).
\3\ Burden associated with OMB Control No. 0910-0001: Applications for FDA Approval to Market a New Drug.
Table 2--Estimated Reporting Burden \1\ \2\ \3\
----------------------------------------------------------------------------------------------------------------
Number of
Sec. 601.70 Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Form FDA 3988................... 92 6 552 1 552
Form FDA 3989................... 92 2 184 1 184
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 736
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Total hours for Form FDA 3989 in this table includes and replaces the burden that applicants currently incur
to complete the ASR on PMRs and PMCs that is currently submitted pursuant to Sec. 601.70.
\3\ Burden associated with OMB Control No. 0910-0338: General Licensing Provisions: Biologics License
Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies
Status Reports, and Form FDA 356h (21 CFR part 601).
[[Page 66999]]
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, or
https://www.regulations.gov.
Dated: October 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23290 Filed 10-20-20; 8:45 am]
BILLING CODE 4164-01-P
