Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under the Federal Food, Drug, and Cosmetic Act; Notice; Request for Information and Comments; Reopening of the Comment Period, 49884-49885 [2024-12857]
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Federal Register / Vol. 89, No. 114 / Wednesday, June 12, 2024 / Notices
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
disclosures
per respondent
Number of
respondents
Recommended activity; guidance section
Total annual
disclosures
Average burden
per disclosure
Total hours
3
12
Radiopharmaceutical Compounding and Repackaging by Outsourcing Facilities Guidance
Biannual product reports identifying drug products repackaged by the outsourcing facility during the previous 6-month period (section III.B of the Radiopharmaceutical Compounding and Repackaging Guidance by Outsourcing
Facilities) ............................................................................................................
2
2
4
Repackaging Guidance
Biannual product reports identifying drug products repackaged by the outsourcing facility during the previous 6-month period (section III.A of the Repackaging Guidance) ................................................................................................
6
2
12
3
36
Total ...............................................................................................................
8
..........................
16
..........................
48
ddrumheller on DSK120RN23PROD with NOTICES1
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
For purposes of our analysis, we
characterize the burden associated with
the time and effort expended on the
information collection
recommendations discussed in the
respective guidance documents as either
recordkeeping, reporting, or third-party
disclosure activities. We reconfigured
the original table by splitting it into
three tables to better differentiate
between the estimated annual
recordkeeping burden, the estimated
annual reporting burden, and the
estimated annual third-party disclosure
burden. At the same time, our findings
show that compliance with
recordkeeping requirements applicable
to compounded and repackaged drug
products is standard practice in the
compounding and selling of these drug
products under States’ pharmacy laws
and other State laws governing
recordkeeping by healthcare
professionals and healthcare facilities.
Therefore, we excluded from our
estimate recordkeeping practices
discussed in the respective guidance
documents we consider usual and
customary. We invite comment on this
assumption.
For the Repackaging Guidance, to
correct a clerical error, we have adjusted
the number of disclosures per
respondent from 21 to 36 because each
respondent is estimated to average 6
different products and average 6
different strengths, which requires 36 (6
× 6) unique labels per respondent. The
initial narrative reflected that each
product would come in 6 different
strengths and thus require 6 unique
labels, but due to a clerical error, this
information was not correctly included
in the table. We also adjusted the
number of respondents to 6 to match the
number of respondents designing,
testing, and producing labels. In
addition, we adjusted the total number
VerDate Sep<11>2014
17:43 Jun 11, 2024
Jkt 262001
of disclosures per respondent to 2 given
the biannual reporting requirement.
For the Radiopharmaceutical
Compounding and Repackaging by
Outsourcing Facilities Guidance, a row
for biannual product reporting was
added to capture product reporting that
was inadvertently omitted.
Our estimated burden for the
information collection reflects constant
respondent numbers. The original
numbers were based on the information
the program received from product
reporting data. We do not have a
mechanism in place to determine
whether or not these numbers have
fluctuated upward or downward;
however, based on analogous
observations of industry through
program experience (some product
reports), we believe these numbers are
constant. Repackagers who are also
registered as outsourcing facilities (OF)
are not entity types that are individually
regulated as repackagers. They are
subsumed in the OF entity type and not
easily distinguishable. They may or may
not report their repackaging operations.
We are updating the information
collection to include burden attendant
to reporting and disclosure
recommendations found in the Agency
guidance documents that was
inadvertently omitted in the original
information collection due to clerical
errors. The burden estimate is adjusted
to reflect a resulting increase of 114
hours and 94 responses annually.
Dated: June 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–12783 Filed 6–11–24; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4806]
Implementing Interoperable Systems
and Processes for Enhanced Drug
Distribution Security Requirements
Under the Federal Food, Drug, and
Cosmetic Act; Notice; Request for
Information and Comments;
Reopening of the Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for information
and comments; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
publishing this request for information
to better understand the status of trading
partners’ interoperable systems and
processes for enhanced drug
distribution security as required by the
Food, Drug and Cosmetic Act (FD&C
Act). FDA is reopening the comment
period for the notice, published in the
Federal Register of November 20, 2023,
establishing a public docket and
requesting information and comments,
to allow interested persons additional
time to comment.
DATES: FDA is reopening the comment
period on the notice published
November 20, 2023 (88 FR 80726).
Either electronic or written comments
must be submitted by September 12,
2024.
SUMMARY:
You may submit
information and comments at any time
as follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
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Federal Register / Vol. 89, No. 114 / Wednesday, June 12, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
• 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.
• 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–
2023–N–4806 for ‘‘Implementing
Interoperable Systems and Processes for
Enhanced Drug Distribution Security
Requirements Under Section 582(g)(1)
of the Federal Food, Drug, and Cosmetic
Act.’’ Received comments 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
VerDate Sep<11>2014
17:43 Jun 11, 2024
Jkt 262001
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-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:
Sarah Venti, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 4258, Silver Spring,
MD 20993, 301–796–3130,
drugtrackandtrace@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of November 20, 2023
(88 FR 80726), FDA established a public
docket to solicit comments on
‘‘Implementing Interoperable Systems
and Processes for Enhanced Drug
Distribution Security Requirements
Under Section 582(g)(1) of the Federal
Food, Drug, and Cosmetic Act.’’ The
request for information highlights areas
for consideration and policy
development identified by the Center
for Drug Evaluation and Research
(CDER). The notice includes a series of
questions to stimulate feedback from the
public, including CDER and the Center
for Biologics Evaluation and Research
stakeholders.
Interested persons were originally
given until February 20, 2024, to
comment on the docket.
Following publication of the
November 20, 2023, notice, and in
consideration of the joint public
PO 00000
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49885
meeting organized by FDA and
Partnership for DSCSA Governance
(PDG): ‘‘PDG–FDA Joint Public Meeting:
DSCSA Stabilization Period Midway
Checkpoint’’ scheduled for June 17–18,
2024 (https://www.fda.gov/news-events/
partnership-dscsa-governance-pdgfdajoint-public-meeting-dscsa-stabilizationperiod-midway), FDA has decided to
reopen the public docket to allow
interested persons additional time to
comment.
Dated: June 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–12857 Filed 6–11–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Development of Public Health Vaccine
and Prevention Educational
Campaigns Involving Community
Health Workers
Office of Minority Health, U.S.
Department of Health and Human
Services (HHS).
ACTION: Request for information.
AGENCY:
The U.S. Department of
Health and Human Services (HHS)
Office of Minority Health (OMH) seeks
input on involving community health
workers (CHWs) to increase ‘‘cultural
competency in educational campaigns
on public health vaccines and
prevention, including but not limited to
influenza and COVID–19.’’
DATES: Written comments must be
received electronically at the email
address provided below, no later than
11:59 p.m. on July 11, 2024.
ADDRESSES: OMH invites the
submission of the requested information
through one of the following methods:
• Preferred method: Submit
information through the Federal
eRulemaking Portal at https://
www.regulations.gov. Follow the online
instructions for submissions.
• Email: Send comments to
MinorityHealthInfo@hhs.gov with the
subject line ‘‘OMH RFI: Development of
Public Health Vaccine and Prevention
Educational Campaigns Involving
Community Health Workers.’’
Submissions received after the
deadline will not be reviewed. Respond
concisely and in plain language. You
may use any structure or layout that
presents your information well. You
may respond to some or all of our
questions, and you can suggest other
factors or relevant questions. You may
also include links to online material or
SUMMARY:
E:\FR\FM\12JNN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 114 (Wednesday, June 12, 2024)]
[Notices]
[Pages 49884-49885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12857]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4806]
Implementing Interoperable Systems and Processes for Enhanced
Drug Distribution Security Requirements Under the Federal Food, Drug,
and Cosmetic Act; Notice; Request for Information and Comments;
Reopening of the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for
information and comments; reopening of the comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing
this request for information to better understand the status of trading
partners' interoperable systems and processes for enhanced drug
distribution security as required by the Food, Drug and Cosmetic Act
(FD&C Act). FDA is reopening the comment period for the notice,
published in the Federal Register of November 20, 2023, establishing a
public docket and requesting information and comments, to allow
interested persons additional time to comment.
DATES: FDA is reopening the comment period on the notice published
November 20, 2023 (88 FR 80726). Either electronic or written comments
must be submitted by September 12, 2024.
ADDRESSES: You may submit information and comments at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
[[Page 49885]]
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.
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-2023-N-4806 for ``Implementing Interoperable Systems and Processes
for Enhanced Drug Distribution Security Requirements Under Section
582(g)(1) of the Federal Food, Drug, and Cosmetic Act.'' Received
comments 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: Sarah Venti, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4258, Silver Spring, MD 20993, 301-796-
3130, [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of November 20, 2023
(88 FR 80726), FDA established a public docket to solicit comments on
``Implementing Interoperable Systems and Processes for Enhanced Drug
Distribution Security Requirements Under Section 582(g)(1) of the
Federal Food, Drug, and Cosmetic Act.'' The request for information
highlights areas for consideration and policy development identified by
the Center for Drug Evaluation and Research (CDER). The notice includes
a series of questions to stimulate feedback from the public, including
CDER and the Center for Biologics Evaluation and Research stakeholders.
Interested persons were originally given until February 20, 2024,
to comment on the docket.
Following publication of the November 20, 2023, notice, and in
consideration of the joint public meeting organized by FDA and
Partnership for DSCSA Governance (PDG): ``PDG-FDA Joint Public Meeting:
DSCSA Stabilization Period Midway Checkpoint'' scheduled for June 17-
18, 2024 (https://www.fda.gov/news-events/partnership-dscsa-governance-pdgfda-joint-public-meeting-dscsa-stabilization-period-midway), FDA has
decided to reopen the public docket to allow interested persons
additional time to comment.
Dated: June 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12857 Filed 6-11-24; 8:45 am]
BILLING CODE 4164-01-P
