
[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)]
[Notices]
[Pages 10697-10699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-04131]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0279]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Prescription Drug 
Marketing Act of 1987; Administrative Procedures, Policies, and 
Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March 
30, 2015.

[[Page 10698]]


ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0435. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Prescription Drug Marketing Act of 1987; Administrative Procedures, 
Policies, and Requirements--21 CFR Part 203--(OMB Control No. 0910-
0435)--(Extension)

    FDA is requesting OMB approval under the PRA (44 U.S.C. 3501-3520) 
for the reporting and recordkeeping requirements contained in the 
regulations implementing the Prescription Drug Marketing Act of 1987 
(PDMA). PDMA was 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.
    PDMA was enacted by Congress because there were insufficient 
safeguards in the drug distribution system to prevent the introduction 
and retail sale of substandard, ineffective, or counterfeit drugs, and 
that a wholesale drug diversion submarket had developed that prevented 
effective control over the true sources of drugs.
    Congress found that large amounts of drugs had been reimported into 
the United States as U.S. goods returned causing a health and safety 
risk to U.S. consumers because the drugs may become subpotent or 
adulterated during foreign handling and shipping. Congress also found 
that a ready market for prescription drug reimports had been the 
catalyst for a continuing series of frauds against U.S. manufacturers 
and had provided the cover for the importation of foreign counterfeit 
drugs.
    Congress also determined that the system of providing drug samples 
to physicians through manufacturers' representatives had resulted in 
the sale to consumers of misbranded, expired, and adulterated 
pharmaceuticals.
    The bulk resale of below-wholesale priced prescription drugs by 
health care entities for ultimate sale at retail also helped to fuel 
the diversion market and was an unfair form of competition to 
wholesalers and retailers who had to pay otherwise prevailing market 
prices.
    FDA is requesting OMB approval for the following existing reporting 
and recordkeeping requirements:

                     Table 1--Reporting Requirements
------------------------------------------------------------------------
          21 CFR section                         Requirement
------------------------------------------------------------------------
203.11............................  Applications for re-importation to
                                     provide emergency medical care.
203.30(a)(1) and (b)..............  Drug sample requests (drug samples
                                     distributed by mail or common
                                     carrier).
203.30(a)(3), (a)(4), and (c).....  Drug sample receipts (receipts for
                                     drug samples distributed by mail or
                                     common carrier).
203.31(a)(1) and (b)..............  Drug sample requests (drug samples
                                     distributed by means other than the
                                     mail or a common carrier).
203.31(a)(3), (a)(4), and (c).....  Drug sample receipts (drug samples
                                     distributed by means other than the
                                     mail or a common carrier).
203.37(a).........................  Investigation of falsification of
                                     drug sample records.
203.37(b).........................  Investigation of a significant loss
                                     or known theft of drug samples.
203.37(c).........................  Notification that a representative
                                     has been convicted of certain
                                     offenses involving drug samples.
203.37(d).........................  Notification of the individual
                                     responsible for responding to a
                                     request for information about drug
                                     samples.
203.39(g).........................  Preparation by a charitable
                                     institution of a reconciliation
                                     report for donated drug samples.
------------------------------------------------------------------------


                   Table 2--Recordkeeping Requirements
------------------------------------------------------------------------
          21 CFR section                         Requirement
------------------------------------------------------------------------
203.23(a) and (b).................  Credit memo for returned drugs.
203.23(c).........................  Documentation of proper storage,
                                     handling, and shipping conditions
                                     for returned drugs.
203.30(a)(2) and 203.31(a)(2).....  Verification that a practitioner
                                     requesting a drug sample is
                                     licensed or authorized by the
                                     appropriate State authority to
                                     prescribe the product.
203.31(d)(1) and (d)(2)...........  Contents of the inventory record and
                                     reconciliation report required for
                                     drug samples distributed by
                                     representatives.
203.31(d)(4)......................  Investigation of apparent
                                     discrepancies and significant
                                     losses revealed through the
                                     reconciliation report.
203.31(e).........................  Lists of manufacturers' and
                                     distributors' representatives.
203.34............................  Written policies and procedures
                                     describing administrative systems.
203.37(a).........................  Report of investigation of
                                     falsification of drug sample
                                     records.
203.37(b).........................  Report of investigation of
                                     significant loss or known theft of
                                     drug samples.
203.38(b).........................  Records of drug sample distribution
                                     identifying lot or control numbers
                                     of samples distributed. (The
                                     information collection in 21 CFR
                                     203.38(b) is already approved under
                                     OMB control number 0910-0139).
203.39(d).........................  Records of drug samples destroyed or
                                     returned by a charitable
                                     institution.
203.39(e).........................  Record of drug samples donated to a
                                     charitable institution.
203.39(f).........................  Records of donation and distribution
                                     or other disposition of donated
                                     drug samples.
203.39(g).........................  Inventory and reconciliation of drug
                                     samples donated to charitable
                                     institutions.
203.50(a).........................  Drug origin statement.
203.50(b).........................  Retention of drug origin statement
                                     for 3 years.
203.50(d).........................  List of authorized distributors of
                                     record.
------------------------------------------------------------------------


[[Page 10699]]

    The reporting and recordkeeping requirements are 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 health care 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; 
(6) to prohibit, with certain exceptions, the sale, purchase, or trade 
of, or the offer to sell, purchase, or trade, prescription drugs that 
were purchased by hospitals or other health care entities, or which 
were donated or supplied at a reduced price to a charitable 
organization; and (7) to require unauthorized wholesale distributors to 
provide, prior to the wholesale distribution of a prescription drug to 
another wholesale distributor or retail pharmacy, a statement 
identifying each prior sale, purchase, or trade of the drug.
    In the Federal Register of November 14, 2014 (79 FR 68273), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                21 CFR section                    Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent      respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
203.11 Re-importation........................               1               1               1  .50 (30 minutes).........................               1
203.30(a)(1) and (b) Drug sample requests....          61,961              12         743,532  .06 (4 minutes)..........................          44,612
203.30(a)(3), (a)(4), (c) Drug sample                  61,961              12         743,532  .06 (4 minutes)..........................          44,612
 receipts.
203.31(a)(1) and (b) Drug sample requests....         232,355             135      31,367,925  .04 (2 minutes)..........................       1,254,717
203.31(a)(3), (a)(4), (c) Drug sample                 232,355             135      31,367,925  .03 (2 minutes)..........................         941,038
 receipts.
203.37(a) Falsification of records...........              50               4             200  .25 (15 minutes).........................              50
203.37(b) Loss or theft of samples...........              50              40           2,000  .25 (15 minutes).........................             500
203.37(c) Convictions........................               1               1               1  1........................................               1
203.37(d) Contact person.....................              50               1              50  .08 (5 minutes)..........................               4
203.39(g) Reconciliation report..............               1               1               1  1........................................               1
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................       2,285,536
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                21 CFR section                    Number of      records per    Total annual        Average burden per recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
203.23(a) and (b) Returned drugs.............          31,676               5         158,380  .25 (15 minutes).........................          39,595
203.23(c) Returned drugs documentation.......          31,676               5         158,380  .08 (5 minutes)..........................          12,670
203.30(a)(2) and 203.31(a)(2) Practitioner              2,208             100         220,800  .50 (30 minutes).........................         110,400
 verification.
203.31(d)(1) and (d)(2) Inventory record and            2,208               1           2,208  40.......................................          88,320
 reconciliation report.
203.31(d)(4) Investigation of discrepancies               442               1             442  24.......................................          10,608
 and losses.
203.31(e) Representatives lists..............           2,208               1           2,208  1........................................           2,208
203.34 Administrative systems................              90               1              90  40.......................................           3,600
203.37(a) Falsification of drug sample                     50               4             200  6........................................           1,200
 records.
203.37(b) Loss or theft of drug samples......              50              40           2,000  6........................................          12,000
203.39(d) Destroyed or returned drug samples.              65               1              65  1........................................              65
203.39(e) Donated drug samples...............           3,221               1           3,221  .50 (30 minutes).........................           1,611
203.39(f) Distribution of donated drug                  3,221               1           3,221  8........................................          25,768
 samples.
203.39(g) Drug samples donated to charitable            3,221               1           3,221  8........................................          25,768
 institutions.
203.50(a) Drug origin statement..............             125             100          12,500  .17 (10 minutes).........................           2,125
203.50(b) Drug origin statement retention....             125             100          12,500  .50 (30 minutes).........................           6,250
203.50(d) Authorized distributors of record..             691               1             691  2........................................           1,382
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................         343,570
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: February 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-04131 Filed 2-26-15; 8:45 am]
BILLING CODE 4164-01-P


