Notice2023-03508
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications Procedures and Requirements
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Published
February 21, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 88 Issue 34 (Tuesday, February 21, 2023)</title>
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[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Pages 10520-10522]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03508]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2440]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by March 23, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0338. Also include the FDA docket
number found in brackets in the heading of this document.
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#b5e5e7f4e6c1d4d3d3f5d3d1d49bddddc69bd2dac3"><span class="__cf_email__" data-cfemail="86d6d4c7d5f2e7e0e0c6e0e2e7a8eeeef5a8e1e9f0">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Biologics License Applications (BLAs) 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 (Sec. 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. 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 Sec. 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 Public Health Service (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 Sec. 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
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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.
In the Federal Register of November 1, 2022 (87 FR 65776) we
published a 60-day notice soliciting comment on the proposed collection
of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section or other citation; Form FDA No. Number of responses per Total annual Average burden per response Total hours
activity 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 NA 1 1 1 0.33 (20 minutes)............... 1
with copy of notification to selling
agents and distributors upon
suspension of its license.
601.12(a)(5); Requirement to inform NA 327 10.263 3,356 1............................... 3,356
FDA of changes to an approved
application.
601.12(b)(1), (b)(3), and (e); 356h 195 5.795 1,130 80.............................. 90,400
Requirement 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 356h 73 2.740 200 50.............................. 10,000
FDA of 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 2253 64 2.75 176 40.............................. 7,040
FDA of changes to an approved
application.
601.12(f)(2); Requirement to inform 2253 66 1.758 116 20.............................. 2,320
FDA of changes to an approved
application.
601.12(f)(4) and 601.45; Requirement 2253 173 340.416 58,892 10.............................. 588,920
to inform FDA of changes to an
approved application.
601.27(b); Request for deferred NA 9 1.778 16 24.............................. 384
submission 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 NA 9 1 9 2............................... 18
update a license file with the list
of source materials and the suppliers
of the materials.
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680.1(b)(3)(iv); Requirement to notify NA 1 1 1 2............................... 2
FDA 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 disclosures Total hours
respondents per respondent disclosures \2\
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601.6(a); Requirement to notify selling agents 1 20 20 0.33 (20 minutes)....................... 7
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.
Our estimated burden for the information collection reflects an
overall increase of 467,907 hours and a corresponding increase in
responses. Most of our adjustment reflects an increase in the number of
annual submissions that we have received under Sec. Sec. 601.12(b)(1)
and (3), (e), and (f)(4), and 601.45 over the last few years. We
attribute the remaining increase (358 hours) to submissions of Form FDA
3674.
Dated: February 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03508 Filed 2-17-23; 8:45 am]
BILLING CODE 4164-01-P
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