```

[Federal Register Volume 89, Number 245 (Friday, December 20, 2024)]
[Notices]
[Pages 104188-104191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30355]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/electronic-drug-registration-and-listing-system-edrls. 
Updated daily, a registration database we also maintain that includes a 
publication of currently registered establishments is on our website at 
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site.
    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):
     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).
     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 https://www.fda.gov/media/120092/download), 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.
     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 
https://www.fda.gov/media/175933/download). 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.
     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). 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 https://www.fda.gov/industry/fda-data-standards-advisory-board/structured-product-labeling-resources, 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 https://www.fda.gov/media/89926/download.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
  Collection activity; authority to collect       Number of     responses per   Total annual          Average burden per response           Total hours
                 information                     respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............         353,659  .........................................         323,271
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
```