[Federal Register: June 2, 2006 (Volume 71, Number 106)]
[Notices]
[Page 32097-32099]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jn06-85]
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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
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21 CFR Section Reporting Requirements
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21 CFR 203.11 Applications for reimportation to provide
emergency medical care.
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21 CFR 203.30(a)(1) and (b) Drug sample requests (drug samples
distributed by mail or common carrier).
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21 CFR 203.30(a)(3), (a)(4), Drug sample receipts (receipts for drug
and (c) samples distributed by mail or common
carrier).
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21 CFR 203.31(a)(1) and (b) Drug sample requests (drug samples
distributed by means other than the mail
or a common carrier).
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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).
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21 CFR 203.37(a) Investigation of falsification of drug
sample records.
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21 CFR 203.37(b) Investigation of a significant loss or
known theft of drug samples.
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21 CFR 203.37(c) Notification that a representative has
been convicted of certain offenses
involving drug samples.
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21 CFR 203.37(d) Notification of the individual responsible
for responding to a request for
information about drug samples.
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21 CFR 203.39(g) Preparation by a charitable institution of
a reconciliation report for donated drug
samples.
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Table 2.--Recordkeeping Requirements
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21 CFR Section Recordkeeping Requirements
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21 CFR 203.23(a) and (b) Credit memo for returned drugs.
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21 CFR 203.23(c) Documentation of proper storage, handling,
and shipping conditions for returned
drugs.
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[[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.
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21 CFR 203.31(d)(1) and Contents of the inventory record and
(d)(2) reconciliation report required for drug
samples distributed by representatives.
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21 CFR 203.31(d)(4) Investigation of apparent discrepancies
and significant losses revealed through
the reconciliation report.
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21 CFR 203.31(e) Lists of manufacturers' and distributors'
representatives.
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21 CFR 203.34 Written policies and procedures describing
administrative systems.
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21 CFR 203.37(a) Report of investigation of falsification
of drug sample records.
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21 CFR 203.37(b) Report of investigation of significant
loss or known theft of drug samples.
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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).
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21 CFR 203.39(d) Records of drug samples destroyed or
returned by a charitable institution.
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21 CFR 203.39(e) Record of drug samples donated to a
charitable institution.
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21 CFR 203.39(f) Records of donation and distribution or
other disposition of donated drug
samples.
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21 CFR 203.39(g) Inventory and reconciliation of drug
samples donated to charitable
institutions.
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21 CFR 203.50(a) Drug origin statement.
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21 CFR 203.50(b) Retention of drug origin statement for 3
years.
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21 CFR 203.50(d) List of authorized distributors of record.
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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
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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
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203.37(b) 200 1 200 6.00 1,200
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203.37(c) 50 1 50 1.00 50
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203.37(d) 2,208 1 2,208 .08 177
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203.39(g) 3,221 1 3,221 2.00 6,442
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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
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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