[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]


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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.

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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, 
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.
     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\
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                                                    Number of
   21 CFR citation; activity        Number of     responses per   Total annual    Average burden    Total hours
                                   respondents     respondent       responses      per response
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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
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\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\
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                                                    Number of
                                    Number of      records per    Total annual    Average burden
    Activity; 21 CFR section      recordkeepers   recordkeeper       records           per          Total hours
                                                       \2\                        recordkeeping
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                                          Subpart C: Sales Restrictions
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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.
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                                               Subpart D: Samples
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203.30-203.39; documentation                140             202          28,280  ~.07-.08 (~4-5            2,121
 regarding sample distributions.                                                  minutes).
                                --------------------------------------------------------------------------------
    Total......................  ..............  ..............         345,040  ...............          54,386
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\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


