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, 72403-72407 [2024-19862]
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Federal Register / Vol. 89, No. 172 / Thursday, September 5, 2024 / Notices
proposed revisions to the ACF–696T
will provide reporting instructions to
Tribal Lead Agencies who are approved
under a temporary opportunity to
retroactively request the use CCDF
funds, including most COVID-relief
funds, for construction and/or major
renovation with the intent of offsetting
increased costs of materials, labor, and
other related project costs.
DATES: Comments due within 14 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
above and below.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: ACF programs require
detailed financial information from their
grantees that allows ACF to monitor
various specialized cost categories
within each program, to closely manage
program activities, and to have
sufficient financial information to
enable periodic thorough and detailed
audits. Generic Clearance for Financial
Reports used for ACF Non-Discretionary
Grant Programs allows ACF programs to
efficiently develop and receive approval
for financial reports that are tailored to
specific funding recipients and the
associated needs of the program. For
more information about the umbrella
generic, see: https://www.reginfo.gov/
public/do/PRAViewDocument?ref_
nbr=202108-0970-002.
This specific GenIC collects financial
data for tribal CCDF programs. The
proposed revisions to the ACF–696T
will provide reporting instructions to
Tribal Lead Agencies who are approved
under a temporary opportunity to
retroactively request the use CCDF
funds, including most COVID-relief
funds, for construction and/or major
renovation with the intent of offsetting
increased costs of materials, labor, and
other related project costs.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Title of information collection
ACF–696T ............................................................................................................
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 14 days of this publication.
Authority: 42 U.S.C. 9857, 42 U.S.C.
618.
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–19916 Filed 9–4–24; 8:45 am]
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BILLING CODE 4184–25–P
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219
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.
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
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Hourly
burden per
response
1
Annual
hourly
burden
5
1,095
information must be submitted by
November 4, 2024.
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.
ADDRESSES:
Electronic Submissions
SUMMARY:
PO 00000
Annual
frequency of
responses
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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.
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• 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
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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-201509-18/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, PRAStaff@
fda.hhs.gov.
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,
SUPPLEMENTARY INFORMATION:
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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/regulatoryinformation/search-fda-guidancedocuments.
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,
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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 § 207.61, except as
provided in § 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/guidancecompliance-regulatory-information/
electronic-drug-registration-and-listingsystem-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/drugapprovals-and-databases/drugestablishments-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
Activity; 21 CFR section; statutory citation; guidance
section
Initial establishment registration; §§ 207.17, 207.21, and
207.25 ...............................................................................
Annual review and update of registration information (including expedited updates); § 207.29 ..............................
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Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
593
2
1,186
1
1,186
10,480
3
31,440
0.5
(30 minutes)
15,720
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 ...........................................
3,040
∼7.28
22,130
1.5
33,197
5,153
20
103,060
77,295
Waiver requests; § 207.65 ...................................................
1
1
1
0.75
(45 minutes)
0.5
(30 minutes)
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity; 21 CFR section; statutory citation; guidance
section
Public disclosure exemption request; § 207.81(c) ...............
Manufacturing amount information; section 510(j)(3) of the
FD&C Act .........................................................................
Notify FDA of changes in the production of animal drugs;
‘‘Reporting and Mitigating Animal Drug Shortages,’’ section III ................................................................................
Notify CDER when activating/deactivating Plan; ‘‘Planning
for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products,’’ section
III.F ...................................................................................
Total ..............................................................................
1 There
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
30
1
30
1
30
8,700
22.5
195,750
1
195,750
30
2
60
1
60
2
1
2
16
32
........................
........................
353,659
........................
323,271
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity; guidance section
Preparing Standard Operating Procedures for Creating
and Uploading the Structured Product Labeling File .......
Develop initial Plan; ‘‘Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary
Drug Products,’’ section III ...............................................
Total ..............................................................................
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1 There
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
1,000
1
1,000
40
40,000
70
1
70
250
17,500
........................
........................
1,070
........................
57,500
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
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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
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product code to obtain a new NDC and
the reports of the withdrawal of an
approved drug from sale under
§ 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
§ 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/
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1894]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Yale-Mayo Clinic
Centers of Excellence in Regulatory
Science and Innovation B12 Pediatric
Device Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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 October 7,
2024.
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 0910–0912. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
PO 00000
Frm 00044
Fmt 4703
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72407
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:
Yale-Mayo Clinic Centers of Excellence
in Regulatory Science and Innovation
(CERSI) B12 Pediatric Device Survey
OMB Control Number 0910–0912—
Reinstatement
Despite numerous legislative,
regulatory, and scientific efforts, there
has been little change in the number of
devices approved for use in pediatric
patients. This has often led to devices
being adapted for use in children
without an appropriate level of
evidence, exposing them to inconsistent
benefit risk profiles. This health
inequity highlights the need for devices
that are designed, evaluated, and
labeled for pediatric patients. To
address these challenges, this collection
is being done to survey industry and
other key stakeholders in the medical
device ecosystem to identify the barriers
that prevent product developers from
entering the pediatric device market as
well as the proper incentives that would
motivate them to innovate and sustain
within this market.
This survey is a followup to the
public meeting that FDA held in August
2018, entitled, ‘‘Pediatric Medical
Device Development.’’ As mandated by
section 502(d) of the FDA
Reauthorization Act of 2017 (Pub. L.
115–52) the meeting was convened to
address several topics, including
consideration of ways to: (1) increase
FDA assistance to medical device
manufacturers in developing devices for
pediatric populations that are approved
or cleared, and labeled, for their use and
(2) identify current barriers to pediatric
device development and incentives to
address such barriers.
Feedback from this meeting clarified
the need to better understand factors
influencing suboptimal engagement and
participation by diverse innovators in
the pediatric medical device space.
Information garnered from this survey
may help inform strategic plans to
optimize existing programs for the
needs of pediatric medical device
innovators and develop new programs
that will support sustained development
in this space.
In the Federal Register of May 22,
2024 (89 FR 44993), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
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]]>Agencies
[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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity; guidance section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
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
