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, 104188-104191 [2024-30355]
Download as PDF
<![CDATA[
104188
Federal Register / Vol. 89, No. 245 / Friday, December 20, 2024 / Notices
620 and the average burden hours per
response increased from 0.17 to 0.33.
• Key Personnel Minimum
Qualifications Checklist and Attestation
(Form A–14)
Æ Revise the introductory text to the
form to remove repetition and improve
readability.
Æ Revise Section D: Candidate
Minimum Qualifications to:
■ Reorganize how the minimum
qualifications for each position are
displayed to make it easier for the
respondent to understand the
requirements.
■ Change the ‘‘Candidate does not
meet minimum qualification’’ checkbox
into a question that asks ‘‘Does the
candidate meet the minimum
qualification?’’ with yes/no options so
that the respondent may more clearly
communicate whether the candidate
meets minimum qualifications.
■ Update the qualifications for each
position and add two new positions
(Background Check Specialist and Lead
Medical Coordinator) to reflect revisions
that are under consideration for ORR’s
residential services cooperative
agreement.
Æ Revise the burden estimate to
account for an increase in the number
of care provider facilities, a decrease in
the number of forms submitted, and
more accurately reflect how long it takes
to complete the form. The annual
number of respondents increased from
235 to 300, the annual number of
responses per respondent decreased
from nine to six, and the average burden
hours per response increased from 0.17
to 0.42.
• ORR Waiver Request (Form A–15)
Æ Add a burden statement at the top
of the form.
Æ Break the form into several sections
to make it more digestible for
respondents.
Æ Rephrase several field labels for
clarity and succinctness.
Æ Add a field for the respondent to
specify whether they are a care provider
facility or a home study or post-release
service provider.
Æ Change the ‘‘Type of Facility/
Provider’’ field label to ‘‘Level of Care’’
and update the related checkbox options
to better reflect care provider facility
levels of care.
Annual
number of
respondents
ddrumheller on DSK120RN23PROD with NOTICES1
Form
Æ Add a place where respondents can
upload a supervision or training plan
when applicable for their request.
Æ Revise the burden estimate to
account for an increase in the number
of care provider facilities. The annual
number of respondents increased from
235 to 300.
Revisions to Burden Estimates Only for
Existing Forms
• Authorization for Release of
Records (Form A–5)
Æ Revise the burden estimate to
account for an increase in the number
records requests submitted and more
accurately reflect how long it takes to
complete the form. The annual number
of respondents increased from 4,000 to
9,620 and the average burden hours per
response increased from 0.25 to 0.5.
Respondents: ORR grantee and
contractor staff; advocacy groups, faithbased organizations, researchers, and
government officials; attorneys, legal
service providers, child advocates, and
government agencies; and other
stakeholders.
Annual Burden Estimates:
Number of
responses per
respondent
Average
burden hours
per response
Annual total
burden hours
Care Provider Facility Tour Request (Form A–1A) .........................................
Notice to Unaccompanied Children for Flores Visits (Forms A–4 and A–4s)
Authorization for Release of Records (Form A–5) ..........................................
Key Personnel Minimum Qualifications Checklist and Attestation (Form A–
14) ................................................................................................................
ORR Waiver Request (Form A–15) .................................................................
620
20
9,620
1
1
1
0.33
0.25
0.50
205
5
4,810
300
300
6
2
0.42
0.33
756
198
Estimated Annual Burden Hours Total: ....................................................
........................
........................
........................
5,974
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 6 U.S.C. 279; 8 U.S.C.
1232; 45 CFR 410; Flores v. Reno
Settlement Agreement, No. CV85–4544–
RJK (C.D. Cal. 1996)
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–30384 Filed 12–19–24; 8:45 am]
BILLING CODE 4184–45–P
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.
VerDate Sep<11>2014
20:12 Dec 19, 2024
Jkt 265001
PO 00000
Frm 00117
Fmt 4703
Sfmt 4703
ACTION:
Notice.
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
SUMMARY:
E:\FR\FM\20DEN1.SGM
20DEN1
Federal Register / Vol. 89, No. 245 / Friday, December 20, 2024 / Notices
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Registration of Producers of Drugs and
Listing of Drugs in Commercial
Distribution and Related Collections of
Information
ddrumheller on DSK120RN23PROD with NOTICES1
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/regulatoryinformation/search-fda-guidancedocuments. Because FDA relies on
establishment registration and drug
listing information for several of its
programs, complete, accurate, and upto-date information is essential to FDA’s
role in ensuring public health.
VerDate Sep<11>2014
20:12 Dec 19, 2024
Jkt 265001
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 § 207.61
(21 CFR 207.61), except as provided in
§ 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/guidancecompliance-regulatory-information/
electronic-drug-registration-and-listingsystem-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/drugestablishments-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://
PO 00000
Frm 00118
Fmt 4703
Sfmt 4703
104189
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
E:\FR\FM\20DEN1.SGM
20DEN1
104190
Federal Register / Vol. 89, No. 245 / Friday, December 20, 2024 / Notices
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-advisoryboard/structured-product-labelingresources, 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
Collection activity; authority to collect information
Initial establishment registration; §§ 207.17, 207.21,
and 207.25.
Annual review and update of registration information (including expedited updates); § 207.29.
Initial listing (including National Drug Code (NDC));
§§ 207.33, 207.41, 207.45, 207.49, 207.53,
207.54, and 207.55.
June and December review and update (or certification) of listing; §§ 207.35 and 207.57.
Waiver requests; § 207.65 .........................................
Public disclosure exemption request; § 207.81(c) ....
Manufacturing amount information; FD&C Act section 510(j)(3).
Maintenance of, and notifications associated with,
plans to ensure availability of medically necessary drug products during emergency; FDA
topic-specific guidance, section III.F.
Reporting and Mitigating Animal Drug Shortages;
FDA topic-specific Guidance, section III.
Total ...................................................................
ddrumheller on DSK120RN23PROD with NOTICES1
1 There
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average burden per
response
Total hours
593
2
1,186
1 ...............................
1,186
10,480
3
31,440
0.5 (30 minutes) .......
15,720
3,040
7.28
22,130
1.5 ............................
33,197
5,153
20
103,060
0.75 (45 minutes) .....
77,295
1
30
8,700
1
1
22.5
1
30
195,750
0.5 (30 minutes) .......
1 ...............................
1 ...............................
1
30
195,750
2
1
2
16 .............................
32
30
2
60
1 ...............................
60
........................
........................
353,659
..................................
323,271
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
VerDate Sep<11>2014
20:12 Dec 19, 2024
Jkt 265001
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.
PO 00000
Frm 00119
Fmt 4703
Sfmt 4703
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
§ 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 § 207.81
from 100 to 30 to reflect a decrease of
activity.
E:\FR\FM\20DEN1.SGM
20DEN1
ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 245 / Friday, December 20, 2024 / Notices
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
VerDate Sep<11>2014
20:12 Dec 19, 2024
Jkt 265001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
Program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 8W–25A,
Rockville, Maryland 20857; (301) 443–
6593, or visit our website at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
SUMMARY:
The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the United States Court of Federal
Claims and to serve a copy of the
petition to the Secretary of HHS, who is
named as the respondent in each
proceeding. The Secretary has delegated
this responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00120
Fmt 4703
Sfmt 4703
104191
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
manifested outside the time periods
specified in the Table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111 the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
October 1, 2024, through October 31,
2024. This list provides the name of the
petitioner, city, and State of vaccination
(if unknown then the city and State of
the person or attorney filing the claim),
and case number. In cases where the
Court has redacted the name of a
petitioner and/or the case number, the
list reflects such redaction.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
submit relevant, written information’’
relating to the following:
1. The existence of evidence ‘‘that
there is not a preponderance of the
evidence that the illness, disability,
injury, condition, or death described in
the petition is due to factors unrelated
to the administration of the vaccine
described in the petition,’’ and
2. Any allegation in a petition that the
petitioner either:
a. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition not set forth in the
Vaccine Injury Table but which was
caused by’’ one of the vaccines referred
to in the Table, or
b. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition set forth in the
Vaccine Injury Table the first symptom
or manifestation of the onset or
significant aggravation of which did not
occur within the time period set forth in
the Table but which was caused by a
vaccine’’ referred to in the Table.
E:\FR\FM\20DEN1.SGM
20DEN1
]]>Agencies
[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
