[Federal Register Volume 76, Number 108 (Monday, June 6, 2011)]
[Notices]
[Pages 32362-32364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13442]
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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;
Reports and Records Under 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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 the reporting and
recordkeeping requirements contained in the regulations implementing
the Prescription Drug Marketing Act of 1987 (PDMA).
DATES: Submit either electronic or written comments on the collection
of information by August 5, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
P150-400B, Rockville, MD 20850, 301-796-3792,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 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.
[[Page 32363]]
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 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), and Drug sample receipts (receipts for
(c). drug 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), and Drug sample receipts (drug samples
(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.
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Table 2--Recordkeeping Requirements
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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.
21 CFR 203.30(a)(2) and Verification that a practitioner
203.31(a)(2). requesting a drug sample is
licensed or authorized by the
appropriate State authority to
prescribe the product.
21 CFR 203.31(d)(1) and (d)(2).... Contents of the inventory record and
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.
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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; (7) to require unauthorized wholesale distributors to
provide, prior to the wholesale distribution of a prescription drug to
another wholesale distributor or
[[Page 32364]]
retail pharmacy, a statement identifying each prior sale, purchase, or
trade of the drug.
FDA estimates the burden of this collection of information as
follows:
Table 3--Estimated Annual Reporting Burden\1\
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Number of Average burden
21 CFR section Number of responses per Total annual per response Total hours
respondents respondent responses (in hours) \2\
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203.11........................... 1 1 1 30/60 .50
203.30(a)(1) and (b)............. 61,961 12 743,532 4/60 44,612
203.30(a)(3), (a)(4), and (c).... 61,961 12 743,532 4/60 44,612
203.31(a)(1) and (b)............. 232,355 135 31,367,925 2/60 1,254,717
203.31(a)(3), (a)(4), and (c).... 232,355 135 31,367,925 2/60 941,038
203.37(a)........................ 50 4 200 15/60 50
203.37(b)........................ 50 40 2,000 15/60 500
203.37(c)........................ 1 1 1 1 1
203.37(d)........................ 50 1 50 5/60 4
203.39(g)........................ 1 1 1 1 1
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Total........................ .............. .............. .............. .............. 2,285,535.50
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
minutes per response]/60''.
Table 4--Estimated Annual Recordkeeping Burden\1\
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Average burden
Number of Number of Total annual per
21 CFR section recordkeepers records per records recordkeeping Total hours
recordkeeper (in hours) \2\
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203.23(a) and (b)............... 31,676 5 158,380 15/60 39,595
203.23(c)....................... 31,676 5 158,380 5/60 12,670
203.30(a)(2) and 203.31(a)(2)... 2,208 100 220,800 30/60 110,400
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 2,000 6 1,200
203.39(d)....................... 65 1 65 1 65
203.39(e)....................... 3,221 1 3,221 30/60 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 10/60 2,125
203.50(b)....................... 125 100 12,500 30/60 6,250
203.50(d)....................... 691 1 691 2 1,382
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Total....................... .............. .............. .............. .............. 332,769
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\1\ There are capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
minutes per response]/60''.
Dated: May 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13442 Filed 6-3-11; 8:45 am]
BILLING CODE 4160-01-P