Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements, 68273-68275 [2014-26917]
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Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices
beneficiaries and to educate
beneficiaries about the process. If a prior
authorization request is not affirmed,
and the claim is still submitted by the
provider/supplier, the claim will be
denied in full, but beneficiaries will
continue to have all applicable
administrative appeal rights.
Only one prior authorization request
per beneficiary per designated time
period can be provisionally affirmed. If
the initial provider/supplier cannot
complete the total number of prior
authorized transports (for example, the
initial ambulance company closes or no
longer services that area), the initial
request is cancelled. In this situation, a
subsequent prior authorization request
may be submitted for the same
beneficiary and must include the
required documentation in the
submission. If multiple ambulance
providers/suppliers are providing
transports to the beneficiary during the
same or overlapping time period, the
prior authorization decision will only
cover the provider/supplier indicated in
the provisionally affirmed prior
authorization request. Any provider/
supplier submitting claims for repetitive
scheduled nonemergent ambulance
transports for which no prior
authorization request is recorded will be
subject to 100 percent prepayment
medical review of those claims.
Additional information is available on
the CMS Web site at https://go.cms.gov/
PAAmbulance.
III. Collection of Information
Requirements
Section 1115A(d)(3) of the Act, as
added by section 3021 of the Affordable
Care Act, states that chapter 35 of title
44, United States Code (the Paperwork
Reduction Act of 1995), shall not apply
to the testing and evaluation of models
or expansion of such models under this
section. Consequently, this document
need not be reviewed by the Office of
Management and Budget under the
authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 35).
mstockstill on DSK4VPTVN1PROD with NOTICES
Authority: Section 1115A of the Social
Security Act.
Dated: October 8, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2014–26987 Filed 11–13–14; 8:45 am]
BILLING CODE 4120–01–P
VerDate Sep<11>2014
17:37 Nov 13, 2014
Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0279]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prescription Drug
Marketing Act of 1987; Administrative
Procedures, Policies, and
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 information collection in the
regulations on the Prescription Drug
Marketing Act of 1987; Administrative
Procedures, Policies, and Requirements.
DATES: Submit either electronic or
written comments on the collection of
information by January 13, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://
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: 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: 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.
SUMMARY:
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Fmt 4703
Sfmt 4703
68273
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). 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
E:\FR\FM\14NON1.SGM
14NON1
68274
Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices
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 .............................................
203.30(a)(1) and (b) ........................
203.30(a)(3), (a)(4), and (c) ............
203.31(a)(1) and (b) ........................
203.31(a)(3), (a)(4), and (c) ............
203.37(a) .........................................
203.37(b) .........................................
203.37(c) .........................................
203.37(d) .........................................
203.39(g) .........................................
Applications for re-importation to provide emergency medical care.
Drug sample requests (drug samples distributed by mail or common carrier).
Drug sample receipts (receipts for drug samples distributed by mail or common carrier).
Drug sample requests (drug samples distributed by means other than the mail or a common carrier).
Drug sample receipts (drug samples distributed by means other than the mail or a common carrier).
Investigation of falsification of drug sample records.
Investigation of a significant loss or known theft of drug samples.
Notification that a representative has been convicted of certain offenses involving drug samples.
Notification of the individual responsible for responding to a request for information about drug samples.
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) ............................
203.23(c) .........................................
203.30(a)(2) and 203.31(a)(2) ........
Credit memo for returned drugs.
Documentation of proper storage, handling, and shipping conditions for returned drugs.
Verification that a practitioner requesting a drug sample is licensed or authorized by the appropriate State
authority to prescribe the product.
Contents of the inventory record and reconciliation report required for drug samples distributed by representatives.
Investigation of apparent discrepancies and significant losses revealed through the reconciliation report.
Lists of manufacturers’ and distributors’ representatives.
Written policies and procedures describing administrative systems.
Report of investigation of falsification of drug sample records.
Report of investigation of significant loss or known theft of drug samples.
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).
Records of drug samples destroyed or returned by a charitable institution.
Record of drug samples donated to a charitable institution.
Records of donation and distribution or other disposition of donated drug samples.
Inventory and reconciliation of drug samples donated to charitable institutions.
Drug origin statement.
Retention of drug origin statement for 3 years.
List of authorized distributors of record.
203.31(d)(1) and (d)(2) ...................
203.31(d)(4) ....................................
203.31(e) .........................................
203.34 .............................................
203.37(a) .........................................
203.37(b) .........................................
203.38(b) .........................................
203.39(d) .........................................
203.39(e) .........................................
203.39(f) ..........................................
203.39(g) .........................................
203.50(a) .........................................
203.50(b) .........................................
203.50(d) .........................................
mstockstill on DSK4VPTVN1PROD with NOTICES
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
203.11 Re-importation .............................................
203.30(a)(1) and (b) Drug sample requests ............
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Number of
responses
per
respondent
1
61,961
Frm 00066
Fmt 4703
Total annual
respondents
1
12
Sfmt 4703
1
743,532
E:\FR\FM\14NON1.SGM
Average burden
per response
.50 (30 minutes) ........
.06 (4 minutes) ..........
14NON1
Total hours
1
44,612
Federal Register / Vol. 79, No. 220 / Friday, November 14, 2014 / Notices
68275
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses
per
respondent
Number of
respondents
21 CFR section
Total annual
respondents
Average burden
per response
Total hours
203.30(a)(3), (a)(4), (c) Drug sample receipts ........
203.31(a)(1) and (b) Drug sample requests ............
203.31(a)(3), (a)(4),(c) Drug sample receipts ..........
203.37(a) Falsification of records ............................
203.37(b) Loss or theft of samples ..........................
203.37(c) Convictions ..............................................
203.37(d) Contact person ........................................
203.39(g) Reconciliation report ................................
61,961
232,355
232,355
50
50
1
50
1
12
135
135
4
40
1
1
1
743,532
31,367,925
31,367,925
200
2000
1
50
1
.06 (4 minutes) ..........
.04 (2 minutes) ..........
.03 (2 minutes) ..........
.25 (15 minutes) ........
.25 (15 minutes) ........
1 ................................
.08 (5 minutes) ..........
1 ................................
44,612
1,254,717
941,038
50
500
1
4
1
Total ..................................................................
........................
........................
........................
....................................
2,285,536
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
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average burden
per record-keeping
Total hours
203.23(a) and (b) Returned drugs ...........................
203.23(c) Returned drugs documentation ...............
203.30(a)(2)
and
203.31(a)(2)
Practitioner
verification.
203.31(d)(1) and (d)(2) Inventory record and reconciliation report.
203.31(d)(4) Investigation of discrepancies and
losses.
203.31(e) Representatives lists ...............................
203.34 Administrative systems ................................
203.37(a) Falsification of drug sample records .......
203.37(b) Loss or theft of drug samples .................
203.39(d) Destroyed or returned drug samples ......
203.39(e) Donated drug samples ............................
203.39(f) Distribution of donated drug samples ......
203.39(g) Drug samples donated to charitable institutions.
203.50(a) Drug origin statement ..............................
203.50(b) Drug origin statement retention ...............
203.50(d) Authorized distributors of record .............
31,676
31,676
2,208
5
5
100
158,380
158,380
220,800
.25 (15 minutes) ........
.08 (5 minutes) ..........
.50 (30 minutes) ........
39,595
12,670
110,400
2,208
1
2,208
40 ..............................
88,320
442
1
442
24 ..............................
10,608
2,208
90
50
50
65
3,221
3,221
3,221
1
1
4
40
1
1
1
1
2,208
90
200
2000
65
3,221
3,221
3,221
1 ................................
40 ..............................
6 ................................
6 ................................
1 ................................
.50 (30 minutes) ........
8 ................................
8 ................................
2,208
3,600
1200
12,000
65
1,611
25,768
25,768
125
125
691
100
100
1
12,500
12,500
691
.17 (10 minutes) ........
.50 (30 minutes) ........
2 ................................
2,125
6,250
1,382
Total ..................................................................
........................
........................
........................
....................................
343,570
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–26917 Filed 11–13–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2013–N–0878]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Premarket
Notification for a New Dietary
Ingredient
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
17:37 Nov 13, 2014
Jkt 235001
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 procedure by which a manufacturer
or distributor of a new dietary
ingredient or of a dietary supplement
containing a new dietary ingredient is to
submit to FDA information upon which
it has based its conclusion that a dietary
supplement containing the new dietary
ingredient will reasonably be expected
SUMMARY:
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
to be safe. The notice also invites
comments on two new forms FDA is
developing to allow manufacturers and
distributors to submit this information
electronically via FDA’s Unified
Registration and Listing System
(FURLS).
Submit either electronic or
written comments on the collection of
information by January 13, 2015.
DATES:
Submit electronic
comments on the collection of
information to https://
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
ADDRESSES:
E:\FR\FM\14NON1.SGM
14NON1
]]>Agencies
[Federal Register Volume 79, Number 220 (Friday, November 14, 2014)]
[Notices]
[Pages 68273-68275]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26917]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0279]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prescription Drug Marketing Act of 1987;
Administrative Procedures, Policies, and Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 information collection in
the regulations on the Prescription Drug Marketing Act of 1987;
Administrative Procedures, Policies, and Requirements.
DATES: Submit either electronic or written comments on the collection
of information by January 13, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to: https://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: 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: 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). 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
[[Page 68274]]
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.
------------------------------------------------------------------------
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.
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
[[Page 68275]]
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 2000 .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
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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
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Number of
21 CFR section Number of records per Total annual Average burden per record-keeping Total hours
recordkeepers recordkeeper records
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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......................................... 1200
records.
203.37(b) Loss or theft of drug samples..... 50 40 2000 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
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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: November 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26917 Filed 11-13-14; 8:45 am]
BILLING CODE 4164-01-P
