[Federal Register Volume 71, Number 106 (Friday, June 2, 2006)]
[Notices]
[Pages 32097-32099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8569]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0081]


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

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 July 3, 
2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

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


                  Table 2.--Recordkeeping Requirements
------------------------------------------------------------------------
       21 CFR Section                 Recordkeeping Requirements
------------------------------------------------------------------------
21 CFR 203.23(a) and (b)      Credit memo for returned drugs.
------------------------------------------------------------------------
21 CFR 203.23(c)              Documentation of proper storage, handling,
                               and shipping conditions for returned
                               drugs.
------------------------------------------------------------------------

[[Page 32098]]

 
21 CFR 203.30(a)(2) and 21    Verification that a practitioner
 CFR 203.31(a)(2)              requesting a drug sample is licensed or
                               authorized to prescribe the product.
------------------------------------------------------------------------
21 CFR 203.31(d)(1) and       Contents of the inventory record and
 (d)(2)                        reconciliation report required for drug
                               samples distributed by representatives.
------------------------------------------------------------------------
21 CFR 203.31(d)(4)           Investigation of apparent discrepancies
                               and significant losses revealed through
                               the reconciliation report.
------------------------------------------------------------------------
21 CFR 203.31(e)              Lists of manufacturers' and distributors'
                               representatives.
------------------------------------------------------------------------
21 CFR 203.34                 Written policies and procedures describing
                               administrative systems.
------------------------------------------------------------------------
21 CFR 203.37(a)              Report of investigation of falsification
                               of drug sample records.
------------------------------------------------------------------------
21 CFR 203.37(b)              Report of investigation of significant
                               loss or known theft of drug samples.
------------------------------------------------------------------------
21 CFR 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).
------------------------------------------------------------------------
21 CFR 203.39(d)              Records of drug samples destroyed or
                               returned by a charitable institution.
------------------------------------------------------------------------
21 CFR 203.39(e)              Record of drug samples donated to a
                               charitable institution.
------------------------------------------------------------------------
21 CFR 203.39(f)              Records of donation and distribution or
                               other disposition of donated drug
                               samples.
------------------------------------------------------------------------
21 CFR 203.39(g)              Inventory and reconciliation of drug
                               samples donated to charitable
                               institutions.
------------------------------------------------------------------------
21 CFR 203.50(a)              Drug origin statement.
------------------------------------------------------------------------
21 CFR 203.50(b)              Retention of drug origin statement for 3
                               years.
------------------------------------------------------------------------
21 CFR 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; 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.

                                                     Table 3.--Estimated Annual Reporting Burden \1\
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                                                              No. of         No. of Responses       Total Annual        Hours per
                    21 CFR Section                         Respondents        per Respondent         Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
203.11                                                                 12                     1                 12                 .5                  6
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203.30(a)(1) and (b)                                               61,961                    12            743,532                .06             44,612
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203.30(a)(3), (a)(4), and (c)                                      61,961                    12            743,532                .06             44,612
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203.31(a)(1) and (b)                                              232,355                   135         31,367,925                .04          1,254,717
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203.31(a)(3), (a)(4), and (c)                                     232,355                   135         31,367,925                .03            941,038
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203.37(a)                                                              25                     1                 25               6.00                150
--------------------------------------------------------------------------------------------------------------------------------------------------------
203.37(b)                                                             200                     1                200               6.00              1,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
203.37(c)                                                              50                     1                 50               1.00                 50
--------------------------------------------------------------------------------------------------------------------------------------------------------
203.37(d)                                                           2,208                     1              2,208                .08                177
--------------------------------------------------------------------------------------------------------------------------------------------------------
203.39(g)                                                           3,221                     1              3,221               2.00              6,442
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Reporting Burden Hours                                                                                                                   2,293,004
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 32099]]


                                                   Table 4.--Estimated Annual Recordkeeping Burden\1\
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                                                              No. of         No. of Responses       Total Annual        Hours per
                    21 CFR Section                         Respondents        per Respondent         Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
203.23(a) and (b)                                                  31,676                     5            158,380                .25             39,595
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203.23(c)                                                          31,676                     5            158,380                .08             12,670
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203.30(a)(2) and 203.31(a)(2)                                       2,208                   100            220,800                .50            110,400
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203.31(d)(1) and (d)(2)                                             2,208                     1              2,208              40.00             88,320
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203.31(d)(4)                                                          442                     1                442              24.00             10,608
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203.31(e)                                                           2,208                     1              2,208               1.00              2,208
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203.34                                                              2,208                     1              2,208              40.00             88,320
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203.37(a)                                                              25                     1                 25              18.00                450
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203.37(b)                                                             200                     1                200              18.00              3,600
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203.39(d)                                                              65                     1                 65               1.00                 65
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203.39(e)                                                           3,221                     1              3,221                .50              1,610
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203.39(f)                                                           3,221                     1              3,221               8.00             25,768
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203.39(g)                                                           3,221                     1              3,221               8.00             25,768
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203.50(a)                                                               0                     0                  0                  0                  0
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203.50(b)                                                               0                     0                  0                  0                  0
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203.50(d)                                                               0                     0                  0                  0                  0
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Total Recordkeeping Burden Hours                                                                                                                 409,409
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the Federal Register of March 16, 2006 (71 FR 13599), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

    Dated: May 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-8569 Filed 6-1-06; 8:45 am]
BILLING CODE 4160-01-S