Agency Information Collection Activities; Proposed Collection; Comment Request; Importation of Prescription Drugs, 37549-37551 [2023-12258]
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Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Notices
Authority for the Antimicrobial
Drugs Advisory Committee will expire
on October 7, 2024, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: SheChia Chen, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 240–402–5343,
AMDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Antimicrobial Drugs
Advisory Committee (the Committee).
The Committee is a discretionary
Federal advisory committee established
to provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of infectious
diseases and disorders and makes
appropriate recommendations to the
Commissioner.
The Committee shall consist of a core
of 13 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of infectious
disease, internal medicine,
microbiology, pediatrics, epidemiology
or statistics, and related specialties.
Members will be invited to serve for
overlapping terms of up to 4 years. NonFederal members of this committee will
serve as Special Government
Employees, representatives or Ex-Officio
members. Federal members will serve as
Regular Government Employees or ExOfficios. The core of voting members
may include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting representative
member who is identified with industry
interests. There may also be an alternate
industry representative.
Further information regarding the
most recent charter and other
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DATES:
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information can be found at https://
www.fda.gov/advisory-committees/
antimicrobial-drugs-advisorycommittee-formerly-known-antiinfective-drugs-advisory-committee/
antimicrobial-drugs-advisorycommittee-formerly-known-antiinfective-drugs-advisory-committee or
by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: June 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–12288 Filed 6–7–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1189]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Importation of
Prescription Drugs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, 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
collection provisions related to FDA’s
regulation on importation of
prescription drugs.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
August 7, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
SUMMARY:
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37549
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
August 7, 2023. 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.
• 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–1189 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Importation of Prescription Drugs.’’
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
E:\FR\FM\08JNN1.SGM
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37550
Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Notices
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-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:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, 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:
when appropriate, and other forms of
information technology.
Importation of Prescription Drugs—21
CFR Part 251
OMB Control Number 0910–0888—
Extension
This information collection supports
implementation of section 804 of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 384), and
applicable regulations in part 251 (21
CFR part 251). The purpose of section
804 of the FD&C Act is to reduce the
cost of covered products to American
consumers without imposing additional
risk to public health and safety. The
regulations in part 251 set forth
procedures Section 804 Importation
Program sponsors (SIP Sponsors) must
follow when submitting plans to
implement time-limited programs to
begin importation of drugs from Canada.
The regulations also establish criteria
for FDA review and authorization of a
SIP proposal or supplemental proposal.
Additionally, the regulations set forth
requirements for eligible prescription
drugs and requirements for entities that
engage in importation of eligible
prescription drugs. Finally, the
regulations provide for exempt eligible
prescription drugs that meet certain
requirements from section 502(f)(1) of
the FD&C Act (21 U.S.C. 352(f)(1)).
Description of Respondents:
Respondents to the collection of
information are SIP Sponsors (States or
Indian Tribes, or in certain future
circumstances, pharmacists or
wholesale distributors, and any
cosponsor(s)), importers (pharmacists or
wholesaler distributors), and
manufacturers of eligible prescription
drugs.
We estimate the burden of the
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
ddrumheller on DSK120RN23PROD with NOTICES1
21 CFR section 251; information collection activity
Number of
respondents
Number of
records per
recordkeeper
Total annual
records
Average
burden per
record
Total hours
Subpart B; SIP proposals and pre-import requests ............
Subpart C; Certain requirements for importation programs
40
40
1.5
1
60
40
72
43
4,320
1,720
Total ..............................................................................
........................
........................
100
........................
6,040
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We have established a web page at
https://www.fda.gov/about-fda/reports/
importation-drugs-originally-intendedforeign-markets to communicate news
and information about FDA efforts to
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implement the Section 804 Importation
Program. To date, however, no SIP
proposals have been authorized since
publication of the final rule on October
1, 2020 (85 FR 62094). We have
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therefore retained figures based on our
original impact analysis estimating that
40 SIP sponsors will each submit a SIP
proposal or pre-import request. We
assume burden attributable to the
E:\FR\FM\08JNN1.SGM
08JNN1
Federal Register / Vol. 88, No. 110 / Thursday, June 8, 2023 / Notices
required retention and disclosure of
records pertaining to these information
collection activities will be distributed
among respondents for an average of
100 responses and 6,040 hours
annually.
Dated: June 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–12258 Filed 6–7–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–1275]
Demonstrating Bioequivalence for
Type A Medicated Articles Containing
Active Pharmaceutical Ingredient(s)
Considered To Be Poorly Soluble in
Aqueous Media, That Exhibit Little to
No Systemic Bioavailability, and Are
Locally Acting; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry (GFI) #279
entitled ‘‘Demonstrating Bioequivalence
for Type A Medicated Articles
Containing Active Pharmaceutical
Ingredient(s) Considered To Be Poorly
Soluble in Aqueous Media, That Exhibit
Little to No Systemic Bioavailability,
and Are Locally Acting; Draft Guidance
for Industry.’’ This draft guidance
describes an approach to satisfy the
requirements for the completion of the
Bioequivalence technical section for
generic Type A medicated articles
(TAMAs) containing poorly soluble,
locally acting, active pharmaceutical
ingredients (APIs) that have little to no
systemic absorption, and for which
blood level studies are not considered
appropriate to demonstrate product
bioequivalence. The suggested approach
described in this draft guidance uses a
combination of in vitro and in vivo data
to support a determination of
bioequivalence to address the unique
challenges associated with
demonstrating bioequivalence of
TAMAs containing poorly soluble,
locally acting APIs that have little to no
systemic absorption.
DATES: Submit either electronic or
written comments on the draft guidance
by August 7, 2023 to ensure that the
Agency considers your comment on this
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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16:15 Jun 07, 2023
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draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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.
• 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–D–1275 for ‘‘Demonstrating
Bioequivalence for Type A Medicated
Articles Containing Active
Pharmaceutical Ingredient(s)
Considered To Be Poorly Soluble in
Aqueous Media, That Exhibit Little to
No Systemic Bioavailability, and Are
Locally Acting.’’ 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.
PO 00000
Frm 00047
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37551
• 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-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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
Ian
Hendricks, Center for Veterinary
Medicine (HFV–172), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0853,
Ian.Hendricks@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\08JNN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 110 (Thursday, June 8, 2023)]
[Notices]
[Pages 37549-37551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12258]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1189]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Importation of Prescription Drugs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, 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 collection
provisions related to FDA's regulation on importation of prescription
drugs.
DATES: Either electronic or written comments on the collection of
information must be submitted by August 7, 2023.
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 August 7, 2023. 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.
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-1189 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Importation of Prescription
Drugs.'' 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
[[Page 37550]]
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: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[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.
Importation of Prescription Drugs--21 CFR Part 251
OMB Control Number 0910-0888--Extension
This information collection supports implementation of section 804
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384),
and applicable regulations in part 251 (21 CFR part 251). The purpose
of section 804 of the FD&C Act is to reduce the cost of covered
products to American consumers without imposing additional risk to
public health and safety. The regulations in part 251 set forth
procedures Section 804 Importation Program sponsors (SIP Sponsors) must
follow when submitting plans to implement time-limited programs to
begin importation of drugs from Canada. The regulations also establish
criteria for FDA review and authorization of a SIP proposal or
supplemental proposal. Additionally, the regulations set forth
requirements for eligible prescription drugs and requirements for
entities that engage in importation of eligible prescription drugs.
Finally, the regulations provide for exempt eligible prescription drugs
that meet certain requirements from section 502(f)(1) of the FD&C Act
(21 U.S.C. 352(f)(1)).
Description of Respondents: Respondents to the collection of
information are SIP Sponsors (States or Indian Tribes, or in certain
future circumstances, pharmacists or wholesale distributors, and any
cosponsor(s)), importers (pharmacists or wholesaler distributors), and
manufacturers of eligible prescription drugs.
We estimate the burden of the collection of information as follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section 251; information Number of records per Total annual Average burden Total hours
collection activity respondents recordkeeper records per record
----------------------------------------------------------------------------------------------------------------
Subpart B; SIP proposals and pre- 40 1.5 60 72 4,320
import requests................
Subpart C; Certain requirements 40 1 40 43 1,720
for importation programs.......
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Total....................... .............. .............. 100 .............. 6,040
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We have established a web page at https://www.fda.gov/about-fda/reports/importation-drugs-originally-intended-foreign-markets to
communicate news and information about FDA efforts to implement the
Section 804 Importation Program. To date, however, no SIP proposals
have been authorized since publication of the final rule on October 1,
2020 (85 FR 62094). We have therefore retained figures based on our
original impact analysis estimating that 40 SIP sponsors will each
submit a SIP proposal or pre-import request. We assume burden
attributable to the
[[Page 37551]]
required retention and disclosure of records pertaining to these
information collection activities will be distributed among respondents
for an average of 100 responses and 6,040 hours annually.
Dated: June 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12258 Filed 6-7-23; 8:45 am]
BILLING CODE 4164-01-P
