Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements, 14128-14130 [2021-05214]
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Federal Register / Vol. 86, No. 47 / Friday, March 12, 2021 / Notices
currently available data and
information, the Agency believes that
the potential problems associated with
bacitracin for injection are sufficiently
serious that the drug should be removed
from the market.
In separate letters dated February 5,
2020, Akorn and Mylan requested that
FDA withdraw approval of ANDAs
206719 and 090211 under § 314.150(d).
Akorn and Mylan each waived their
opportunity for a hearing. Additionally,
in separate letters dated February 7,
2020, Pfizer, X–GEN, and Fresenius
requested that FDA withdraw approval
of ANDAs 060733, 064153, and 065116,
respectively, under § 314.150(d). Pfizer,
X–GEN, and Fresenius also waived their
opportunity for a hearing. Additionally,
Akorn stated that it has never launched
this product since its approval; X–GEN
stated that it no longer manufactures
bacitracin for injection under ANDA
064153; and Mylan stated that its
product has not been in commercial
distribution since 2012.
Therefore, for the reasons discussed
above, which the applicants do not
dispute in their letters requesting
withdrawal of approval under
§ 314.150(d), FDA’s approval of ANDAs
206719, 090211, 060733, 064153,
065116, and all amendments and
supplements thereto, is withdrawn (see
DATES). Distribution of Akorn’s
bacitracin for injection (50,000 units/
vial), Mylan’s bacitracin for injection
(50,000 units/vial), Pfizer’s bacitracin
for injection (10,000 units/vial and
50,000 units/vial), X–GEN’s bacitracin
for injection (50,000 units/vial), or
Fresenius’s bacitracin for injection
(50,000 units/vial) into interstate
commerce without an approved
application is illegal and subject to
regulatory action (see sections 505(a)
and 301(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(a) and
331(d))).
Dated: March 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05105 Filed 3–11–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0279]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prescription Drug
Marketing; Administrative Procedures,
Policies, and Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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 information
collection associated with prescription
drug marketing under the Prescription
Drug Marketing Act of 1987 and the
Prescription Drug Amendments of 1992.
DATES: Submit either electronic or
written comments on the collection of
information by May 11, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 11, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 11, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
SUMMARY:
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,
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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–
2011–N–0279 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Prescription Drug Marketing;
Administrative Procedures, Policies,
and Requirements.’’ 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
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Federal Register / Vol. 86, No. 47 / Friday, March 12, 2021 / Notices
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:
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.
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.
Prescription Drug Marketing—21 CFR
Part 203
OMB Control Number 0910–0435—
Extension
This information collection supports
FDA regulations codified at part 203 (21
CFR part 203) implementing the
Prescription Drug Marketing Act of 1987
(PDMA) and the Prescription Drug
Amendments of 1992. The Federal
Food, Drug, and Cosmetic Act (FD&C
Act), as amended by the PDMA,
establishes requirements for the
following:
• Reimportation of prescription
drugs.
• The sale, purchase, or trade of or
the offer to sell, purchase, or trade,
prescription drugs that were purchased
by hospitals or health care entities or
donated to charitable organizations.
• The distribution of prescription
drug samples by mail, common carrier,
or another means of distribution.
• Applications for reimportation to
provide emergency medical care.
14129
• An appeal from an adverse decision
by the district office.
• Drug sample storage and handling.
• Fulfillment houses, shipping and
mailing services, comarketing
agreements, and third-party
recordkeeping.
• Donation of drug samples to
charitable institutions.
The PDMA was enacted, in part,
because insufficient safeguards existed
over the drug distribution system to
prevent the introduction and retail sale
of substandard, ineffective, or
counterfeit drugs. The PDMA is
intended to ensure that drug products
purchased by consumers are safe and
effective, and to avoid an unacceptable
risk that counterfeit, adulterated,
misbranded, subpotent, or expired drugs
are sold.
The applicable regulations in part 203
include reporting and recordkeeping
requirements intended to help achieve
the following goals: (1) To ban the
reimportation of prescription drugs
produced in the United States, except
when reimported by the manufacturer
or under FDA authorization for
emergency medical care; (2) to ban the
sale, purchase, or trade, or the offer to
sell, purchase, or trade, of any
prescription drug sample; (3) to limit
the distribution of drug samples to
practitioners licensed or authorized to
prescribe such drugs or to pharmacies of
hospitals or other healthcare entities at
the request of a licensed or authorized
practitioner; (4) to require licensed or
authorized practitioners to request
prescription drug samples in writing; (5)
to mandate storage, handling, and
recordkeeping requirements for
prescription drug samples; and (6) to
prohibit, with certain exceptions, the
sale, purchase, or trade, or the offer to
sell, purchase, or trade, of prescription
drugs that were purchased by hospitals
or other healthcare entities or that were
donated or supplied at a reduced price
to a charitable organization.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR citation; activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
203.11; reimportation applications ..................................
203.37(a); falsification of records ...................................
203.37(b); loss or theft of samples .................................
203.37(c); conviction of representatives .........................
203.37(d); contact person ..............................................
1
140
140
1
20
1
21.4
178.57
1
1
1
3,000
25,000
1
20
.5 (30 minutes) ...
.25 (15 minutes)
.25 (15 minutes)
1 ..........................
.25 (15 minutes)
21
750
6,250
1
5
Total .........................................................................
........................
........................
28,022
.............................
7,007
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
to the nearest whole number.
2 Rounded
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Federal Register / Vol. 86, No. 47 / Friday, March 12, 2021 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity; 21 CFR section
Number of
records per
recordkeeper 2
Average
burden per
recordkeeping
Total annual
records
Total hours
Subpart C: Sales Restrictions
203.23(a) and (b); returns ..............................................
203.23(c); documentation of storage of returns .............
2,200
2,200
71.9909
71.9909
158,380
158,380
.25 (15 minutes)
.08 (6 minutes) ...
39,595
12,670
Subpart D: Samples
203.30–203.39; documentation regarding sample distributions.
140
202
28,280
Total .........................................................................
........................
........................
345,040
1 There
∼.07–.08 (∼4–5
minutes).
.............................
2,121
54,386
are no capital costs or operating and maintenance costs associated with this collection of information.
to the nearest whole number.
2 Rounded
Based on a review of Agency data, we
assume 2,200 respondents may incur
burden resulting from the information
collection activity associated with the
requirements in § 203.23(a) through (c).
One hundred and forty pharmaceutical
companies have submitted information
to the Agency on drug sample
distribution under part 203. Those same
respondents also have recordkeeping
requirements under part 203. Our
estimate of the burden of the average
burden per recordkeeping reflects a
cumulative average to cover all
applicable requirements. Since our last
request for OMB approval, we have
adjusted our estimate of the overall
burden downward to reflect a decrease
of 2,567,713 hours and 64,432,232
records annually. We attribute this
adjustment to a more accurate reflection
of the number of respondents to the
information collection and clarification
that burden attributable to requirements
of the Drug Quality and Security Act are
not included in this information
collection.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05214 Filed 3–11–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that AMONDYS 45
(casimersen), manufactured by Sarepta
Therapeutics Inc., meets the criteria for
a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9856,
email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that AMONDYS 45
(casimersen) manufactured by Sarepta
Therapeutics Inc., meets the criteria for
a priority review voucher. AMONDYS
45 (casimersen) is indicated for the
treatment of Duchenne Muscular
Dystrophy (DMD) in patients who have
a confirmed mutation of the DMD gene
that is amenable to exon 45 skipping.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
SUMMARY:
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DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about AMONDYS
45 (casimersen), go to the ‘‘Drugs@FDA’’
website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05208 Filed 3–11–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2197]
VistaPharm, Inc., et.al.; Withdrawal of
Approval of 10 Abbreviated New Drug
Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on December 11, 2020. The
document announced the withdrawal of
approval (as of January 11, 2021) of 10
abbreviated new drug applications
(ANDAs) from multiple applicants. The
document indicated that FDA was
withdrawing approval of the following
two ANDAs after receiving a withdrawal
request from VistaPharm, Inc., 7265
Ulmerton Rd., Largo, FL 33771: ANDA
040323, Prednisolone Syrup, 15
milligrams (mg)/5 milliliters (mL); and
ANDA 075782, Valproic Acid Syrup,
250 mg/5 mL. Before FDA withdrew the
approval of these ANDAs, VistaPharm,
Inc., informed FDA that it did not want
SUMMARY:
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]]>Agencies
[Federal Register Volume 86, Number 47 (Friday, March 12, 2021)]
[Notices]
[Pages 14128-14130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05214]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0279]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prescription Drug Marketing; Administrative
Procedures, Policies, and Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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 information collection associated with
prescription drug marketing under the Prescription Drug Marketing Act
of 1987 and the Prescription Drug Amendments of 1992.
DATES: Submit either electronic or written comments on the collection
of information by May 11, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 11, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 11, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is 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-2011-N-0279 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Prescription Drug Marketing;
Administrative Procedures, Policies, and Requirements.'' 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
[[Page 14129]]
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.
Prescription Drug Marketing--21 CFR Part 203
OMB Control Number 0910-0435--Extension
This information collection supports FDA regulations codified at
part 203 (21 CFR part 203) implementing the Prescription Drug Marketing
Act of 1987 (PDMA) and the Prescription Drug Amendments of 1992. The
Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the
PDMA, establishes requirements for the following:
Reimportation of prescription drugs.
The sale, purchase, or trade of or the offer to sell,
purchase, or trade, prescription drugs that were purchased by hospitals
or health care entities or donated to charitable organizations.
The distribution of prescription drug samples by mail,
common carrier, or another means of distribution.
Applications for reimportation to provide emergency
medical care.
An appeal from an adverse decision by the district office.
Drug sample storage and handling.
Fulfillment houses, shipping and mailing services,
comarketing agreements, and third-party recordkeeping.
Donation of drug samples to charitable institutions.
The PDMA was enacted, in part, because insufficient safeguards
existed over the drug distribution system to prevent the introduction
and retail sale of substandard, ineffective, or counterfeit drugs. The
PDMA is intended to ensure that drug products purchased by consumers
are safe and effective, and to avoid an unacceptable risk that
counterfeit, adulterated, misbranded, subpotent, or expired drugs are
sold.
The applicable regulations in part 203 include reporting and
recordkeeping requirements intended to help achieve the following
goals: (1) To ban the reimportation of prescription drugs produced in
the United States, except when reimported by the manufacturer or under
FDA authorization for emergency medical care; (2) to ban the sale,
purchase, or trade, or the offer to sell, purchase, or trade, of any
prescription drug sample; (3) to limit the distribution of drug samples
to practitioners licensed or authorized to prescribe such drugs or to
pharmacies of hospitals or other healthcare entities at the request of
a licensed or authorized practitioner; (4) to require licensed or
authorized practitioners to request prescription drug samples in
writing; (5) to mandate storage, handling, and recordkeeping
requirements for prescription drug samples; and (6) to prohibit, with
certain exceptions, the sale, purchase, or trade, or the offer to sell,
purchase, or trade, of prescription drugs that were purchased by
hospitals or other healthcare entities or that were donated or supplied
at a reduced price to a charitable organization.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR citation; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
203.11; reimportation 1 1 1 .5 (30 minutes) \2\ 1
applications.
203.37(a); falsification of 140 21.4 3,000 .25 (15 750
records. minutes).
203.37(b); loss or theft of 140 178.57 25,000 .25 (15 6,250
samples. minutes).
203.37(c); conviction of 1 1 1 1.............. 1
representatives.
203.37(d); contact person...... 20 1 20 .25 (15 5
minutes).
--------------------------------------------------------------------------------
Total...................... .............. .............. 28,022 ............... 7,007
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Rounded to the nearest whole number.
[[Page 14130]]
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of records per Total annual Average burden
Activity; 21 CFR section recordkeepers recordkeeper records per Total hours
\2\ recordkeeping
----------------------------------------------------------------------------------------------------------------
Subpart C: Sales Restrictions
----------------------------------------------------------------------------------------------------------------
203.23(a) and (b); returns..... 2,200 71.9909 158,380 .25 (15 39,595
minutes).
203.23(c); documentation of 2,200 71.9909 158,380 .08 (6 minutes) 12,670
storage of returns.
----------------------------------------------------------------------------------------------------------------
Subpart D: Samples
----------------------------------------------------------------------------------------------------------------
203.30-203.39; documentation 140 202 28,280 ~.07-.08 (~4-5 2,121
regarding sample distributions. minutes).
--------------------------------------------------------------------------------
Total...................... .............. .............. 345,040 ............... 54,386
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Rounded to the nearest whole number.
Based on a review of Agency data, we assume 2,200 respondents may
incur burden resulting from the information collection activity
associated with the requirements in Sec. 203.23(a) through (c). One
hundred and forty pharmaceutical companies have submitted information
to the Agency on drug sample distribution under part 203. Those same
respondents also have recordkeeping requirements under part 203. Our
estimate of the burden of the average burden per recordkeeping reflects
a cumulative average to cover all applicable requirements. Since our
last request for OMB approval, we have adjusted our estimate of the
overall burden downward to reflect a decrease of 2,567,713 hours and
64,432,232 records annually. We attribute this adjustment to a more
accurate reflection of the number of respondents to the information
collection and clarification that burden attributable to requirements
of the Drug Quality and Security Act are not included in this
information collection.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05214 Filed 3-11-21; 8:45 am]
BILLING CODE 4164-01-P
