[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

[[Page 72407]]

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