Notice2022-23728
Agency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications Procedures and Requirements
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Published
November 1, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency or we) 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 collection of information associated with biologics license application (BLA) procedures and requirements.
Full Text
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<title>Federal Register, Volume 87 Issue 210 (Tuesday, November 1, 2022)</title>
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[Federal Register Volume 87, Number 210 (Tuesday, November 1, 2022)]
[Notices]
[Pages 65776-65779]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23728]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2440]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Biologics License Applications Procedures and
Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency or we) 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 collection of information
associated with biologics license application (BLA) procedures and
requirements.
DATES: Either electronic or written comments on the collection of
information must be submitted by January 3, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 3, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2022-N-2440 for ``Biologics License Applications Procedures and
Requirements.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
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,
<a href="/cdn-cgi/l/email-protection#1d4d4f5c4e697c7b7b5d7b797c3375756e337a726b"><span class="__cf_email__" data-cfemail="49191b081a3d282f2f092f2d286721213a672e263f">[email protected]</span></a>.
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 Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing 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
[[Page 65777]]
of automated collection techniques, when appropriate, and other forms
of information technology.
Biologics License Applications Procedures and Requirements
OMB Control Number 0910-0338--Extension
This information collection supports Agency regulations and
recommendations found in associated guidance pertaining to BLA
procedures and requirements. A BLA is a request for permission to
introduce, or deliver for introduction, a biological product into
interstate commerce (601.2 (21 CFR 601.2)). BLAs are regulated under
parts 600 through 680 (21 CFR parts 600 through 680). A BLA is
submitted by any legal person or entity who is engaged in manufacture
or an applicant for a license who takes responsibility for compliance
with product and establishment standards. Interested persons may visit
<a href="https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber">https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-applications-bla-process-cber</a> for
additional information, including available Agency resources.
Regulations in part 601 set forth applicable procedures for the
submission of license application information, including content and
format elements. The regulations also explain requirements for
suspension, revocation, and reissuance of BLAs and communicate
procedures for requesting a hearing. Additionally, the information
collection includes the submission of manufacturing change information
governed by section 506A of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 356a), as well as postmarketing reports for
approved human drugs and licensed biological products governed by
section 506B of the FD&C Act (21 U.S.C. 356b). Finally, regulations in
parts 610 through 680 establish both general and specific biological
product standards.
To implement these provisions, we have developed the following
collection instruments:
1. Forms
Form FDA 356h, Application to Market a New or Abbreviated New Drug
or Biologic for Human Use, provides a uniform format for submitting
BLAs. Form FDA 356h is a fillable PDF form that may be submitted
through our Electronic Submission Gateway (ESG), for which respondents
must create and maintain a user account. Utilizing Form FDA 356h helps
to ensure that an application is complete and contains all the
necessary information, so that delays due to lack of information may be
avoided. In addition, the form provides key information to FDA for
efficient handling and distribution to the appropriate staff for
review. We have recently made minor updates to Form FDA 356h resulting
from the October 3, 2022, reauthorization of the Prescription Drug User
Fee Act (PDUFA). In this collection we account for BLAs submitted using
Form FDA 356h.
Form FDA 2252, Transmittal of Annual Report for Drugs and Biologics
for Human Use, is used by an applicant of a licensed biological product
to submit annual reports required by Sec. 601.70(b) (21 CFR
601.70(b)). Form FDA 2252 is also a fillable PDF form and approved in
OMB control number 0910-0001; however, in this information collection
we account for submissions pertaining to biological products.
Form FDA 2253, Transmittal of Advertisements and Promotional
Labeling for Drugs and Biologics for Human Use, was developed for use
by respondents to transmit specimens of advertisements and promotional
labeling (e.g., circulars, package labels, container labels, etc.), as
well as labeling changes. The submission of this information is
required by 601.12 (21 CFR 601.12) for biological products and by 21
CFR 314.81 for drug products. Form FDA 2253 is a fillable PDF form and
is approved for use in OMB control number 0910-0001; however, in this
information collection we account for submissions pertaining to
biological products.
Form FDA 3674, Certificate of Compliance Under 42 U.S.C.
282(j)(5)(B), with Requirements of <a href="http://ClinicalTrials.gov">ClinicalTrials.gov</a> Data Bank, was
developed for use by respondents to certify submissions as required by
section 402(j)(5)(B) of the PHS Act and is submitted through our ESG.
Form FDA 3674 is a fillable PDF form and is approved for use in OMB
control number 0910-0616; however, in this information collection we
account for submissions pertaining to biological products.
2. Cover Sheets
As provided for under part 601.2(a), we also utilize cover sheets,
so denoted for purposes of identifying specific content information
within a given application.
3. Guidance Documents
The guidance document ``Cooperative Manufacturing Arrangements for
Licensed Biologics,'' (November 2008), available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cooperative-manufacturing-arrangements-licensed-biologics">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cooperative-manufacturing-arrangements-licensed-biologics</a>, discusses
strategies for meeting an increased need for flexible manufacturing
arrangements. Since cooperative manufacturing arrangements can take a
considerable amount of time to develop, the guidance is intended to be
useful for planning purposes in the early phases of product
development. Many companies that perform only limited aspects of
manufacturing processes are interested in sharing or contracting parts
of manufacturing to facilitate product development and manufacturing
flexibility. The guidance discusses recommended communication between
licensed manufacturers and contract manufacturers regarding changes to
production and facilities, results of tests and investigations
regarding the product, types of products manufactured in the contract
facility, and standard operating procedures. We believe that the
information collection provisions in the guidance do not create a new
burden for respondents. We believe the reporting and recordkeeping
provisions are part of usual and customary business practices.
All Agency guidance documents issued are consistent with our good
guidance practice regulations in 21 CFR 10.115, which provide for
public comment at any time. We maintain a searchable database of our
guidance documents at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>.
Respondents to this collection of information are licensed
manufacturers of biological products. Based on the number of 2021
fiscal year application submissions, we estimate there are 371 such
respondents. The total annual responses are based on the number of
submissions (i.e., license applications, labeling and other
supplements, protocols, advertising and promotional labeling,
notifications) for a particular product received annually by FDA. The
hours per response are based on informal communications with industry
and our experience with the information collection.
We estimate the burden of this collection of information as
follows:
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Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section or other citation; activity Form FDA No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \2\
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601.2(a) and 610.60 through 610.65; 356h 51 1.078 55 860......................... 47,300
Application for biologics license
(includes labeling).
601.5(a); Requirement to notify FDA of NA 17 1.0589 18 0.33 (20 minutes)........... 6
intention to discontinue manufacture of a
product or all products.
601.6(a); Requirement to provide FDA with NA 1 1 1 0.33 (20 minutes)........... 1
copy of notification to selling agents
and distributors upon suspension of its
license.
601.12(a)(5); Requirement to inform FDA of NA 327 10.263 3,356 1........................... 3,356
changes to an approved application.
601.12(b)(1), (b)(3), and (e); Requirement 356h 195 5.795 1,130 80.......................... 90,400
to inform FDA of changes to an approved
application.
601.12(c)(1) and (3); Requirement to 356h 153 4.6536 712 50.......................... 35,600
inform FDA of changes to an approved
application.
601.12(c)(5); Requirement to inform FDA of 356h 73 2.740 200 50.......................... 10,000
changes to an approved application.
601.12(d)(1), (d)(3), and (f)(3); 356h 279 3.398 948 24.......................... 22,752
Requirement to inform FDA of changes to
an approved application.
601.12(f)(1); Requirement to inform FDA of 2253 64 2.75 176 40.......................... 7,040
changes to an approved application.
601.12(f)(2); Requirement to inform FDA of 2253 66 1.758 116 20.......................... 2,320
changes to an approved application.
601.12(f)(4) and 601.45; Requirement to 2253 173 340.416 58,892 10.......................... 588,920
inform FDA of changes to an approved
application.
601.27(b); Request for deferred submission NA 9 1.778 16 24.......................... 384
of some or all safety and effectiveness
assessments.
601.27(c); Request for full or partial NA 8 1 8 8........................... 64
waiver of safety and effectiveness
assessments.
601.70(b) and (d), and 601.28; Annual 2252 101 1.84 186 24.......................... 4,464
progress reports of postmarketing studies.
610.15(d); Request for exceptions or NA 1 1 1 1........................... 1
alternatives to the regulation for
constituent materials.
680.1(c); Requirement to annually update a NA 9 1 9 2........................... 18
license file with the list of source
materials and the suppliers of the
materials.
680.1(b)(3)(iv); Requirement to notify FDA NA 1 1 1 2........................... 2
when certain diseases are detected in
source materials.
601.12; Amendments/Resubmissions.......... 356h 170 27.888 4741 20.......................... 94,820
Section 402(j)(5)(B) of the PHS Act; 3674 1,291 1 1,291 0.28 (17 minutes)........... 358
Certification to accompany biological
product applications.
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Total................................. .............. .............. .............. .............. ............................ 907,806
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The numbers in this column have been rounded to the nearest whole number.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
21 CFR section; activity Number of disclosures Total annual Average burden per Total
respondents per respondent disclosures disclosure hours \2\
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601.6(a); Requirement to notify 1 20 20 0.33 (20 minutes).. 7
selling agents and distributors
upon suspension of license.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ The number in this column has been rounded to the nearest whole number.
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Our estimated burden for the information collection reflects an
overall increase of 467,907 hours and a corresponding increase in
responses. We attribute part of this adjustment in the total hours to
an increase in the number of submissions that we have received under
601.12(b)(1) and (3), (e), and (f)(4), and 601.45 over the last few
years, which accounts for an increase of 467,549 hours. An additional
increase of 358 hours is associated with certifications on Form FDA
3674.
Dated: October 27, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23728 Filed 10-31-22; 8:45 am]
BILLING CODE 4164-01-P
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