[Federal Register Volume 89, Number 172 (Thursday, September 5, 2024)]
[Notices]
[Pages 72403-72407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19862]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3902]
Agency Information Collection Activities; Proposed Collection;
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, the 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 information collections
related to requirements for drug establishment registration and drug
listing, including registrant reporting under the Federal Food, Drug,
and Cosmetic Act (FD&C Act) with respect to listed drugs and certain
guidances.
DATES: Either electronic or written comments on the collection of
information must be submitted by November 4, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 4, 2024. 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:
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.
[[Page 72404]]
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-2024-N-3902 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Registration of Producers of
Drugs and Listing of Drugs in Commercial Distribution, and Related
Collections of Information.'' 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, 240-402-7500.
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, 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,
[email protected].
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 of automated collection techniques, when
appropriate, and other forms of information technology.
Registration of Producers of Drugs and Listing of Drugs in Commercial
Distribution and Related Collections of Information
OMB Control Number 0910-0045--Extension
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. Agency regulations
implementing drug establishment and registration provisions are found
in part 207 (21 CFR part 207) and include reporting and recordkeeping
requirements. Agency guidance addressing reporting and recordkeeping
provided for by section 510 of the FD&C Act is also addressed in this
information collection. 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
https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
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 regulations governing drug establishment registration and listing,
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. Drug listing
information gives FDA a current inventory of drugs manufactured,
repacked, relabeled, or salvaged for commercial distribution. Data
reported by registrants under section 510(j)(3) of the FD&C Act on the
number of listed drugs they annually manufacture, prepare, propagate,
[[Page 72405]]
compound or process provide FDA with a more comprehensive picture of
the drug supply chain, which can inform operational decisions and
support the Agency's efforts to reduce drug shortage risk. All these
types of information facilitate implementation and enforcement of the
FDC Act and are used for many important public health purposes.
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. Consistent with provisions in
Sec. 207.61, except as provided in Sec. 207.65, all information
submitted under part 207 must be transmitted to FDA in an electronic
format by using our electronic drug registration and listing system, in
a form 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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/electronic-drug-registration-and-listing-system-edrls. To assist respondents in complying with electronic submission
requirements related to drug establishment registration and drug
listing under section 510 of the FD&C Act, we issued the guidance
document entitled ``Providing Regulatory Submissions in Electronic
Format--Drug Establishment Registration and Drug Listing'' (June 2009)
(available at https://www.fda.gov/media/71146/download). Updated daily,
we also maintain a registration database that includes a publication of
currently registered establishments on our website at https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site.
Since our last evaluation of the collection of information, there
have been modifications to certain reporting and recordkeeping
requirements under section 510 of the FD&C Act resulting from
amendments made by the Coronavirus Aid, Relief, and Economic Security
(CARES) Act (Pub. L. 116-136). Relevant to the information collection
described herein, section 510(j) of the FD&C Act was amended to include
the following information collection activities:
Section 510(j)(3) of the FD&C Act, as added by the CARES
Act, requires that registrants under section 510 of the FD&C Act must
annually report the amount of each listed drug that they manufactured,
prepared, propagated, compounded, or processed (hereinafter
manufactured) for commercial distribution. Section 510(j)(3) of the
FD&C Act also authorizes FDA to require that registrants report this
information electronically, and to require that registrants report this
information at the time a public health emergency is declared. To
provide guidance on the submission of the reporting required under
section 510(j)(3) of the FD&C Act, 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
https://www.fda.gov/media/175933/download). In addition to supporting
FDA's response to drug shortages, this guidance on reporting under
section 510(j)(3) also facilitates FDA's access to information useful
in making decisions regarding the appropriate level of drug facility
surveillance.
The guidance document entitled ``Planning for the Effects
of High Absenteeism to Ensure Availability of Medically Necessary Drug
Products'' (March 2011) (available at https://www.fda.gov/media/120092/download) 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; that
guidance discusses the elements that should be covered by such a Plan.
The guidance also recommends respondents notify FDA's Center for Drug
Evaluation and Research (CDER) when activating or deactivating a Plan.
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 https://www.fda.gov/media/137722/download) 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.
The Secretary may issue an order under section
510(j)(3)(B) of the FD&C Act to exempt certain biological products or
categories of biological products regulated under section 351 of the
Public Health Service Act (42 U.S.C. 242) from some or all of the
reporting requirements established in section 510(j)(3)(A) of the FD&C
Act, if the Secretary determines that applying such reporting
requirements to those products (or product categories) is not necessary
to protect the public health, We most recently revised the information
collection to reflect reporting exemptions via such an order pertaining
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).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Activity; 21 CFR section; Number of
statutory citation; guidance Number of responses per Total annual Average burden Total hours
section respondents respondent responses per response
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Initial establishment 593 2 1,186 1 1,186
registration; Sec. Sec.
207.17, 207.21, and 207.25.....
Annual review and update of 10,480 3 31,440 0.5 15,720
registration information (30 minutes)
(including expedited updates);
Sec. 207.29..................
Initial listing (including 3,040 ~7.28 22,130 1.5 33,197
National Drug Code (NDC)); Sec.
Sec. 207.33, 207.41, 207.45,
207.49, 207.53, 207.54, and
207.55.........................
June and December review and 5,153 20 103,060 0.75 77,295
update (or certification) of (45 minutes)
listing; Sec. Sec. 207.35
and 207.57.....................
Waiver requests; Sec. 207.65.. 1 1 1 0.5 1
(30 minutes)
[[Page 72406]]
Public disclosure exemption 30 1 30 1 30
request; Sec. 207.81(c)......
Manufacturing amount 8,700 22.5 195,750 1 195,750
information; section 510(j)(3)
of the FD&C Act................
Notify FDA of changes in the 30 2 60 1 60
production of animal drugs;
``Reporting and Mitigating
Animal Drug Shortages,''
section III....................
Notify CDER when activating/ 2 1 2 16 32
deactivating Plan; ``Planning
for the Effects of High
Absenteeism to Ensure
Availability of Medically
Necessary Drug Products,''
section III.F..................
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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.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Activity; guidance section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Preparing Standard Operating 1,000 1 1,000 40 40,000
Procedures for Creating and
Uploading the Structured
Product Labeling File..........
Develop initial Plan; ``Planning 70 1 70 250 17,500
for the Effects of High
Absenteeism to Ensure
Availability of Medically
Necessary Drug Products,''
section III....................
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Total....................... .............. .............. 1,070 .............. 57,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
According to internal data, we estimate 593 respondents will submit
1,186 new establishment registrations annually. 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. The estimates include 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 estimates include an additional 80 positron
emission tomography drug producers who are not exempt from registration
and approximately 30 manufacturers of plasma derivatives.
We assume 1 hour is necessary for registrants to submit initial
registration information electronically for each new establishment. 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. Our estimate
reflects the average amount of time and effort necessary to register a
domestic or foreign establishment, and the average amount of time and
effort necessary to review and update registration information or
review registration information and certify no changes have occurred.
Based on the number of drugs listed annually over the last few
years, we estimate 3,040 registrants will report approximately 22,131
new listings annually (including the information submitted to obtain a
labeler code and to reserve an NDC for future use). Based on the number
of drugs in our listing database and the current number of changes to
listing information submitted, we estimate 5,153 registrants will each
report 20 reviews and updates (including the information submitted to
revise an NDC) for a total of 103,060 annually. The estimates for the
number of drug listings include both domestic and foreign listings,
listings submitted by registrants for products sold under their own
names as well as products intended for private label distribution, and
information submitted related to an NDC and to obtain a labeler code.
The estimate for the number of drugs subject to the listing
requirements includes positron emission tomography drugs and
approximately 30 plasma derivatives. The estimates for the number of
June and December reviews and updates of listing information include
the number of changes to drug characteristics pertaining to the drug
product code to obtain a new NDC and the reports of the withdrawal of
an approved drug from sale under Sec. 314.81(b)(3)(iii) (21 CFR
314.81(b)(3)(iii)).
Based on our experience with electronically listing submissions
over the last few years, we assume it takes 1 hour and 30 minutes to
submit information electronically for each drug listed for the first
time (for both foreign and domestic registrant listings). These
estimates are an average of the time it will take manufacturers,
repackers, relabelers, and drug product salvagers, with drug product
salvagers taking considerably less time than manufacturers. The
estimates include the time for submitting the content of labeling and
other labeling in an electronic format (for drugs subject to an
approved marketing application, the electronic submission of the
content of labeling under 21 CFR 314.50(l)(1)(i) is approved under OMB
control number 0910-0001). We assume it takes 45 minutes for each June
and December review and update. These estimates represent the average
amount of time to review and update listing information or to review
and certify that no changes have occurred. The estimates include the
time for submitting any labeling for each drug, changes to the drug's
characteristics submitted for a new NDC
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and reports of the withdrawal of an approved drug from sale under Sec.
314.81(b)(3)(iii).
We estimate 1,000 firms will expend 40 hours to prepare, review,
and approve a standard operating procedure (SOP), for a total of 40,000
hours annually. Although we expect most respondents will have already
prepared and implemented an SOP for the electronic submission of drug
establishment registration and drug listing information, we retain an
estimate for new firms that will do so, as recommended in the guidance
document.
Additionally, we assume 10,480 registrants, (accounting for both
biological product and drug product registrants) are subject to the
reporting provisions under section 510(j)(3) of the FD&C Act but
exclude 1,780 respondents to reflect the reporting exemptions
implemented under section 510(j)(3)(B) pertaining to: (1) blood and
blood components for transfusion and (2) cell and gene therapy
products, where one lot treats a single patient. Also, based on
informal communications, we have increased the estimated burden we
attribute to prepare and submit the requisite information for reporting
provisions under section 510(j)(3) of the FD&C Act from 15 minutes to 1
hour.
Regarding notifications to FDA of changes in the production of
animal drugs associated with the guidance document entitled ``Reporting
and Mitigating Animal Drug Shortages,'' we estimate that 30 respondents
will provide two notifications each year and that it will take 1 hour
to prepare and submit each notification.
Finally, regarding the information collection associated with the
guidance document entitled ``Planning for the Effects of High
Absenteeism to Ensure Availability of Medically Necessary Drug
Products,'' 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 16 hours to prepare and submit. As FDA issued the
guidance in 2011, we now assume that most respondents have developed
the recommended Plan, and therefore, we limit our current burden
estimate to updates and maintenance. Accordingly, we estimate 70
manufacturers will update or maintain the recommended Plan and those
changes would take approximately 250 hours per manufacturer.
Our estimated burden for the information collection reflects an
overall decrease of 65,934 responses/records but an overall increase of
144,913 hours annually. We attribute adjustments to our reevaluation of
the number of submissions we received over the last few years for the
provisions in part 207 and the increase in the estimated burden per
response to 1 hour to prepare and submit the requisite information for
the reporting provisions under section 510(j)(3) of the FD&C Act.
Dated: August 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19862 Filed 9-4-24; 8:45 am]
BILLING CODE 4164-01-P