Agency Information Collection Activities: Proposed Collection; Reports and Records Under Prescription Drug Marketing Act of 1987, 32362-32364 [2011-13442]
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Federal Register / Vol. 76, No. 108 / Monday, June 6, 2011 / Notices
Enforcement) 101 Market Street, San
Francisco, California 94105–1579:
1. Castle Creek Capital Partners IV,
LP, Castle Creek Advisors IV, LLC,
Castle Creek Capital IV, LLC, John T.
Pietrzak, Pietrzak Advisory Corp., John
M. Eggemeyer, JME Advisory Corp.,
William J. Ruh, Ruh Advisory Corp.,
Mark G. Merlo, Legions IV Advisory
Corp., Joseph Mikesell Thomas, and
Mikesell Advisory Corp., all of Rancho
Santa Fe, California as a group acting in
concert, to acquire control of
Intermountain Community Bancorp,
and thereby indirectly acquire control of
Panhandle State Bank, both of
Sandpoint, Idaho.
Board of Governors of the Federal Reserve
System, June 1, 2011.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. 2011–13883 Filed 6–3–11; 8:45 am]
BILLING CODE 6210–01–P
FEDERAL RESERVE SYSTEM
jlentini on DSK4TPTVN1PROD with NOTICES
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The application also will be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than July 1, 2011.
A. Federal Reserve Bank of Richmond
(Adam M. Drimer, Assistant Vice
VerDate Mar<15>2010
16:06 Jun 03, 2011
Jkt 223001
President), 701 East Byrd Street,
Richmond, Virginia 23261–4528:
1. ASB Bancorp, Inc., Asheville,
North Carolina, to become a bank
holding company upon the conversion
of Asheville Savings Bank, S.S.B.,
Asheville, North Carolina, from a
mutual to stock form of ownership.
Board of Governors of the Federal Reserve
System, June 1, 2011.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. 2011–13882 Filed 6–3–11; 8:45 am]
BILLING CODE 6210–01–P
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.
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 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:
Elizabeth Berbakos, Office of
SUMMARY:
PO 00000
Frm 00008
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Sfmt 4703
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
P150–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
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.
SUPPLEMENTARY INFORMATION:
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.
E:\FR\FM\06JNN1.SGM
06JNN1
Federal Register / Vol. 76, No. 108 / Monday, June 6, 2011 / Notices
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
32363
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 203.11 ...................................................................
21 CFR 203.30(a)(1) and (b) .............................................
21 CFR 203.30(a)(3), (a)(4), and (c) .................................
21 CFR 203.31(a)(1) and (b) .............................................
21 CFR 203.31(a)(3), (a)(4), and (c) .................................
21 CFR 203.37(a) ..............................................................
21 CFR 203.37(b) ..............................................................
21 CFR 203.37(c) ..............................................................
21 CFR 203.37(d) ..............................................................
21 CFR 203.39(g) ..............................................................
Applications for reimportation 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 203.23(a) and (b) .................................................
21 CFR 203.23(c) ..............................................................
21 CFR 203.30(a)(2) and 203.31(a)(2) ..............................
21 CFR 203.31(d)(1) and (d)(2) .........................................
21 CFR 203.31(d)(4) ..........................................................
CFR
CFR
CFR
CFR
CFR
203.31(e) ..............................................................
203.34 ...................................................................
203.37(a) ..............................................................
203.37(b) ..............................................................
203.38(b) ..............................................................
21
21
21
21
21
21
21
jlentini on DSK4TPTVN1PROD with NOTICES
21
21
21
21
21
CFR
CFR
CFR
CFR
CFR
CFR
CFR
203.39(d) ..............................................................
203.39(e) ..............................................................
203.39(f) ...............................................................
203.39(g) ..............................................................
203.50(a) ..............................................................
203.50(b) ..............................................................
203.50(d) ..............................................................
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
VerDate Mar<15>2010
16:06 Jun 03, 2011
Jkt 223001
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.
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
PO 00000
Frm 00009
Fmt 4703
Sfmt 4703
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
E:\FR\FM\06JNN1.SGM
06JNN1
32364
Federal Register / Vol. 76, No. 108 / Monday, June 6, 2011 / Notices
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 BURDEN1
Number of
respondents
21 CFR section
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
(in hours) 2
Total hours
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) ..............................................................................
1
61,961
61,961
232,355
232,355
50
50
1
50
1
1
12
12
135
135
4
40
1
1
1
1
743,532
743,532
31,367,925
31,367,925
200
2,000
1
50
1
30/60
4/60
4/60
2/60
2/60
15/60
15/60
1
5/60
1
.50
44,612
44,612
1,254,717
941,038
50
500
1
4
1
Total ..............................................................................
........................
........................
........................
........................
2,285,535.50
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
2 Burden
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
(in hours) 2
Total hours
203.23(a) and (b) .................................................................
203.23(c) ..............................................................................
203.30(a)(2) and 203.31(a)(2) .............................................
203.31(d)(1) and (d)(2) ........................................................
203.31(d)(4) .........................................................................
203.31(e) ..............................................................................
203.34 ..................................................................................
203.37(a) ..............................................................................
203.37(b) ..............................................................................
203.39(d) ..............................................................................
203.39(e) ..............................................................................
203.39(f) ...............................................................................
203.39(g) ..............................................................................
203.50(a) ..............................................................................
203.50(b) ..............................................................................
203.50(d) ..............................................................................
31,676
31,676
2,208
2,208
442
2,208
90
50
50
65
3,221
3,221
3,221
125
125
691
5
5
100
1
1
1
1
4
40
1
1
1
1
100
100
1
158,380
158,380
220,800
2,208
442
2,208
90
200
2,000
65
3,221
3,221
3,221
12,500
12,500
691
15/60
5/60
30/60
40
24
1
40
6
6
1
30/60
8
8
10/60
30/60
2
39,595
12,670
110,400
88,320
10,608
2,208
3,600
1,200
1,200
65
1,610
25,768
25,768
2,125
6,250
1,382
Total ..............................................................................
........................
........................
........................
........................
332,769
1 There
are capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
2 Burden
Dated: May 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13442 Filed 6–3–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0375]
BILLING CODE 4160–01–P
jlentini on DSK4TPTVN1PROD with NOTICES
Collaboration in Regulatory Science
and Capacity To Advance Global
Access to Safe Vaccines and
Biologicals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces its
intention to accept and consider a single
SUMMARY:
VerDate Mar<15>2010
16:06 Jun 03, 2011
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source application for award of a
cooperative agreement to the World
Health Organization (WHO) in support
of collaboration in regulatory science
and capacity of National Regulatory
Authorities (NRAs) to advance global
access to safe and effective vaccines and
other biologicals that meet international
standards. The goal of FDA’s Center for
Biologics Evaluation and Research
(FDA/CBER) is to enhance technical
collaboration and cooperation between
FDA, WHO, and its Member States.
DATES: Important dates are as follows:
1. The application due date is July 8,
2011.
2. The anticipated start date is August
15, 2011.
E:\FR\FM\06JNN1.SGM
06JNN1
]]>Agencies
[Federal Register Volume 76, Number 108 (Monday, June 6, 2011)]
[Notices]
[Pages 32362-32364]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13442]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
P150-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.Berbakos@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) (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
------------------------------------------------------------------------
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
Table 2--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.
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.
------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of responses per Total annual per response Total hours
respondents respondent responses (in hours) \2\
----------------------------------------------------------------------------------------------------------------
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
------------------------------------------------------------------------------
Total........................ .............. .............. .............. .............. 2,285,535.50
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per
21 CFR section recordkeepers records per records recordkeeping Total hours
recordkeeper (in hours) \2\
----------------------------------------------------------------------------------------------------------------
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
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 332,769
----------------------------------------------------------------------------------------------------------------
\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
