
[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Pages 60501-60503]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25117]


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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 (the PRA).

DATES: Fax written comments on the collection of information by October 
31, 2011.

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 e-mailed 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: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
juanmanuel.vilela@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 Number 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) (Pub. L. 100-293). 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 reporting and 
recordkeeping requirements:

                     Table 1--Reporting Requirements
------------------------------------------------------------------------
        21 CFR Section                        Requirement
------------------------------------------------------------------------
203.11.......................  Applications for reimportation 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.

[[Page 60502]]

 
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.
------------------------------------------------------------------------

    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; (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 June 6, 2011 (76 FR 32362), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received one comment. The comment did not 
pertain to the information collection discussed in the June 2011 
Federal Register notice, but commended the use of electronic and 
automated health information solutions to reduce costs and improve 
health care efficiency.
    FDA Response: There were no issues raised in the comment to be 
resolved.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 3--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                                                       Average
                                       Number of       Number of     Total annual    burden  per
          21 CFR Section              respondents    responses per    respondents   response  (in   Total hours
                                                      respondent                        hours)
----------------------------------------------------------------------------------------------------------------
203.11............................               1               1               1            .5              .5
203.30(a)(1) and (b)..............          61,961              12         743,532            .06       44,612
203.30(a)(3), (a)(4), and (c).....          61,961              12         743,532            .06       44,612
203.31(a)(1) and (b)..............         232,355             135      31,367,925            .04    1,254,717
203.31(a)(3), (a)(4), and (c).....         232,355             135      31,367,925            .03      941,038
203.37(a).........................              50               4             200            .25           50
203.37(b).........................              50              40           2,000            .25          500
203.37(c).........................               1               1               1           1               1
203.37(d).........................              50               1              50            .08            4
203.39(g).........................               1               1               1           1               1
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    Total.........................  ..............  ..............  ..............  .............    2,285,535.5
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\1\ There are no operating and maintenance costs or capital costs associated with this collection of
  information.


                                 Table 4--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                                                  Average burden
                                     Number of       Number of     Total annual         per
         21 CFR Section            recordkeepers    records per       records      recordkeeping    Total hours
                                                   recordkeeper                     (in hours)
----------------------------------------------------------------------------------------------------------------
203.23(a) and (b)...............          31,676               5         158,380             .25          39,595
203.23(c).......................          31,676               5         158,380             .08          12,670
203.30(a)(2) and 203.31(a)(2)...           2,208             100         220,800             .50         110,400

[[Page 60503]]

 
203.31(d)(1) and (d)(2).........           2,208               1           2,208              40          88,320
203.31(d)(4)....................             442               1             442              24          10,608
203.31(e).......................           2,208               1           2,208               1           2,208
203.34..........................              90               1              90              40           3,600
203.37(a).......................              50               4             200               6           1,200
203.37(b).......................              50              40            2000               6           1,200
203.39(d).......................              65               1              65               1              65
203.39(e).......................           3,221               1           3,221             .50           1,610
203.39(f).......................           3,221               1           3,221               8          25,768
203.39(g).......................           3,221               1           3,221               8          25,768
203.50(a).......................             125             100          12,500             .17           2,125
203.50(b).......................             125             100          12,500             .50           6,250
203.50(d).......................             691               1             691               2           1,382
    Total.......................  ..............  ..............  ..............  ..............         332,769
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\1\ There are no operating and maintenance costs or capital costs associated with this collection of
  information.


    Dated: September 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25117 Filed 9-28-11; 8:45 am]
BILLING CODE 4160-01-P


