Notice2024-30355
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Related Collections of Information
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Published
December 20, 2024
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 89 Issue 245 (Friday, December 20, 2024)</title>
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[Federal Register Volume 89, Number 245 (Friday, December 20, 2024)]
[Notices]
[Pages 104188-104191]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-30355]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3902]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Registration of
Producers of Drugs and Listing of Drugs in Commercial Distribution and
Related Collections of Information
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 January 21, 2025.
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 0910-0045. Also include the FDA docket
number found in
[[Page 104189]]
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#1f4f4d5e4c6b7e79795f797b7e3177776c31787069"><span class="__cf_email__" data-cfemail="da8a889b89aebbbcbc9abcbebbf4b2b2a9f4bdb5ac">[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.
Registration of Producers of Drugs and Listing of Drugs in Commercial
Distribution and Related Collections of Information
OMB Control Number 0910-0045--Revision
This information collection supports implementation of requirements
related to drug establishment registration and listing governed by
section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360), including registrant reporting under section 510(j)(3) of
the FD&C Act with respect to listed drugs. The information collection
also supports implementation of section 510(j)(3)(B) of the FD&C Act,
which authorizes the Secretary of Health and Human Services (the
Secretary), by order, to exempt from some or all of the section
510(j)(3) reporting requirements certain biological products or
categories of biological products regulated under section 351 of the
Public Health Service (PHS) Act if the Secretary determines that such
reporting is not necessary to protect the public health. Agency
regulations implementing drug establishment and registration provisions
are found in part 207 (21 CFR part 207) and include reporting and
recordkeeping requirements.
The information collection utilizes guidance documents intended to
facilitate reporting and recordkeeping provided for by section 510 of
the FD&C Act. All Agency guidance documents are issued consistent with
our good guidance practice regulations in 21 CFR 10.115, which provide
for public comment at any time. To search available FDA guidance
documents, visit the FDA guidance web page at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. Because FDA
relies on establishment registration and drug listing information for
several of its programs, complete, accurate, and up-to-date information
is essential to FDA's role in ensuring public health.
Respondents to the collection of information are domestic
establishments that manufacture, repack, relabel, or salvage a drug, or
an animal feed bearing or containing a new animal drug, and foreign
establishments that manufacture, repack, relabel, or salvage a drug, or
an animal feed bearing or containing a new animal drug, that is
imported or offered for import into the United States. As set forth in
the applicable regulations, when operations are conducted at more than
one establishment and common ownership and control among all the
establishments exists, the parent, subsidiary, or affiliate company may
submit registration information for all establishments. Establishment
registration information helps FDA identify who is manufacturing,
repacking, relabeling, and salvaging drugs and where those operations
are performed.
Consistent with provisions in Sec. 207.61 (21 CFR 207.61), except
as provided in Sec. 207.65 (21 CFR 207.65), all registration and
listing information must be transmitted to FDA using FDA's electronic
drug registration and listing system in an electronic format that we
can process, review, and archive. For more information regarding FDA's
Electronic Drug Registration and Listing System (eDRLS), including
``Latest News'' updates, we encourage respondents to visit our website
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/electronic-drug-registration-and-listing-system-edrls">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/electronic-drug-registration-and-listing-system-edrls</a>.
Updated daily, a registration database we also maintain that includes a
publication of currently registered establishments is on our website at
<a href="https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site">https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site</a>.
Since our last evaluation of the information collection, we have
made the following modifications as a result of the Coronavirus Aid,
Relief, and Economic Security (CARES) Act (Pub. L. 116-136):
<bullet> The scope of activity for the information collection now
reflects exemptions from reporting under section 510(j)(3) of the FD&C
Act applicable to: (1) blood and blood components for transfusion and
(2) cell and gene therapy products, where one lot treats a single
patient, as announced in the Federal Register of April 13, 2023 (88 FR
22454) (April 2023 final order).
<bullet> We have added recommendations from the guidance document
entitled ``Planning for the Effects of High Absenteeism to Ensure
Availability of Medically Necessary Drug Products'' (March 2011)
(available at <a href="https://www.fda.gov/media/120092/download">https://www.fda.gov/media/120092/download</a>), to the scope
of activity included in the collection of information. The guidance
document is intended to encourage manufacturers of drug and therapeutic
biological products, and any raw materials and components used in those
products, to develop a written Emergency Plan (Plan) for maintaining an
adequate supply of medically necessary drug products during an
emergency that results in high employee absenteeism. The guidance
document discusses the elements that should be covered by such a Plan
and recommends notifications to FDA's Center for Drug Evaluation and
Research (CDER) when activating or deactivating a Plan.
<bullet> Section 510(j)(3) of the FD&C Act requires that
registrants annually report the amount of each listed drug that they
manufacture, prepare, propagate, compound, or process (hereinafter
manufacture) for commercial distribution. Section 510(j)(3) of the FD&C
Act also authorizes the Secretary to require that the information be
reported in an electronic format as determined by the Secretary, and
that it be reported at the time a public health emergency is declared.
To provide instruction in this regard, we issued the guidance document
entitled ``Reporting Amount of Listed Drugs and Biological Products
Under Section 510(j)(3) of the FD&C Act'' (February 2024) (available at
<a href="https://www.fda.gov/media/175933/download">https://www.fda.gov/media/175933/download</a>). In addition to supporting
FDA's response to drug shortages, the guidance document is also
intended to facilitate FDA's access to information useful in making
decisions regarding the appropriate level of drug facility
surveillance.
<bullet> As we continue to receive similar information regarding
animal drug shortages, we developed and issued the guidance document
``Reporting and Mitigating Animal Drug Shortages'' (Center for
Veterinary Medicine GFI #271) (May 2023) (available at <a href="https://www.fda.gov/media/137722/download">https://www.fda.gov/media/137722/download</a>). The guidance document is intended
to assist respondents in notifying FDA about changes in the production
of animal drugs that will, in turn, help the Agency in its efforts to
prevent or mitigate shortages of animal drugs.
In the Federal Register of September 5, 2024 (89 FR 72403), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. On our own
initiative however, we are noting some clarifications and modifications
with regard to the information collection and
[[Page 104190]]
are therefore recharacterizing this action as a revision rather than an
extension.
First, we have removed the information collection element
exclusively attributable to the development of standard operating
procedures for providing regulatory submissions in an electronic
format. The requirement to submit registration and listing information
to FDA electronically has been in effect for more than 10 years and is
now standard business practice. We assume that most, if not all,
respondents to the information collection now implement and utilize
electronic data systems compatible with FDA and invite comment on our
assumption. FDA uses a structured product labeling (SPL) standard to
support submissions through our electronic submission gateway (ESG). On
our website at <a href="https://www.fda.gov/industry/fda-data-standards-advisory-board/structured-product-labeling-resources">https://www.fda.gov/industry/fda-data-standards-advisory-board/structured-product-labeling-resources</a>, we provide
informational resources regarding the SPL format standard, including
Agency guidance, intended to assist respondents with technological
considerations in submitting regulatory information to FDA.
Additionally, CDER continues to develop and refine submission tools
that utilize interactive data submission technology for a number of its
programs. We believe most, if not all, respondents to the collection of
information use these platforms to submit required drug registration
and listing information and invite comment on our assumption.
We are also clarifying that submission of the unique facility
identifier (UFI) and the accompanying data elements referenced in
section 510(b), (c), and (i) of the FD&C Act is included among the
scope of activity covered by the information collection. The procedural
guidance document entitled ``Specification of the Unique Facility
Identifier (UFI) System for Drug Establishment Registration,''
(November 2014), explains that FDA's currently preferred UFI for a drug
establishment is the Data Universal Numbering System D-U-N-S (DUNS)
number, assigned and managed by Dun and Bradstreet. FDA has been using
the DUNS number as a registration number for drug establishments since
its implementation of electronic drug registration and listing. The
guidance document is available for download from our website at <a href="https://www.fda.gov/media/89926/download">https://www.fda.gov/media/89926/download</a>.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Collection activity; authority to collect Number of responses per Total annual Average burden per response Total hours
information respondents respondent responses
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Initial establishment registration; Sec. 593 2 1,186 1........................................ 1,186
Sec. 207.17, 207.21, and 207.25.
Annual review and update of registration 10,480 3 31,440 0.5 (30 minutes)......................... 15,720
information (including expedited updates);
Sec. 207.29.
Initial listing (including National Drug Code 3,040 7.28 22,130 1.5...................................... 33,197
(NDC)); Sec. Sec. 207.33, 207.41, 207.45,
207.49, 207.53, 207.54, and 207.55.
June and December review and update (or 5,153 20 103,060 0.75 (45 minutes)........................ 77,295
certification) of listing; Sec. Sec.
207.35 and 207.57.
Waiver requests; Sec. 207.65............... 1 1 1 0.5 (30 minutes)......................... 1
Public disclosure exemption request; Sec. 30 1 30 1........................................ 30
207.81(c).
Manufacturing amount information; FD&C Act 8,700 22.5 195,750 1........................................ 195,750
section 510(j)(3).
Maintenance of, and notifications associated 2 1 2 16....................................... 32
with, plans to ensure availability of
medically necessary drug products during
emergency; FDA topic-specific guidance,
section III.F.
Reporting and Mitigating Animal Drug 30 2 60 1........................................ 60
Shortages; FDA topic-specific Guidance,
section III.
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Total.................................... .............. .............. 353,659 ......................................... 323,271
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Although we denote that table 1 reflects reporting activity, we
include the retention and maintenance of corresponding records in our
calculation and assessment of burden. While there are 10,480
establishments currently registered with FDA, registration and listing
data is subject to frequent fluctuation as a result of the volume of
activity.
Based on our experience with the information collection, we
estimate 593 respondents will submit 1,186 new establishment
registrations annually using the CDER Direct submission platform. We
assume an average of 1 hour is necessary for this activity. Similarly,
we estimate that 10,480 registrants will provide 31,440 annual reviews
and updates of registration information (including expedited updates)
or reviews and certifications that no changes have occurred. Our
estimate includes the registration of establishments for both domestic
and foreign manufacturers, repackers, relabelers, and drug product
salvagers, and registration information submitted by anyone acting as
an authorized agent for an establishment that manufactures, repacks,
relabels, or salvages drugs. The estimate also includes an additional
80 positron emission tomography drug producers who are not exempt from
registration and approximately 30 manufacturers of plasma derivatives.
We assume 30 minutes is necessary for each annual review and update of
registration information (including any expedited updates) or each
review and certification that no changes have occurred.
Although we have not received a request for waiver as provided for
in Sec. 207.65, we retain a placeholder of 1 for such activity and
assume 30 minutes is necessary to prepare and make the submission.
Relatedly, we reduced our estimate of requests for exemption from
public disclosure the information submitted in accordance with Sec.
207.81 from 100 to 30 to reflect a decrease of activity.
[[Page 104191]]
The reporting of manufacturing amount information under section
510(j)(3) of the FD&C Act is a new element to the information
collection. We assume it takes 1 hour to prepare and submit the
necessary reporting information and estimate an average of 22.5 reports
will be submitted annually from 8,700 registrants. We exclude 1,780
respondents from the 10,480 registrants, (accounting for both
biological product and drug product registrants) to reflect the
reporting exemptions implemented under section 510(j)(3)(B). Also,
based on informal communications, we have increased the estimate of
burden we attribute to preparing and submitting the requisite
information from 15 minutes to 1 hour.
Similarly, intending to ensure the availability of medically
necessary drug products during emergencies that might result in high
absenteeism at production facilities, we account for burden associated
with the development of a manufacturing contingency plan as recommended
in Agency guidance ``Planning for the Effects of High Absenteeism to
Ensure Availability of Medically Necessary Drug Products,'' (March
2011), referenced above. We assume that most respondents have already
developed a Plan as recommended by the guidance document as a usual and
customary business practice, and limit therefore, our current burden
estimate to updates, maintenance, and the reporting to FDA of the
activation and deactivation of the Plan. We assume two notifications
(for purposes of this analysis, we consider an activation and a
deactivation notification to equal one notification) will be submitted
to CDER annually, and estimate each notification requires an average of
16 hours to prepare and submit.
Finally, animal drug shortage information is also a new element to
the information collection. Although not statutorily required, we
estimate that 30 respondents will provide 2 notifications annually and
that it will take 1 hour to prepare and submit each notification as
recommended in the guidance document entitled ``Reporting and
Mitigating Animal Drug Shortages,'' referenced above.
Cumulatively, these adjustments and modifications result in a
decrease of 67,004 responses and an increase of 87,413 burden hours,
annually. We have removed burden we attributed to developing and
implementing electronic data systems as we now regard this activity as
usual and customary, however we have increased our estimate of the time
needed for some of the activities to account for corresponding record
maintenance.
Dated: December 16, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-30355 Filed 12-19-24; 8:45 am]
BILLING CODE 4164-01-P
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