Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements, 10697-10699 [2015-04131]
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10697
Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–04138 Filed 2–26–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Annual Report on Households
Assisted by the Low Income Home
Energy Assistance (LIHEAP).
OMB No. 0970–0060.
Description: This report is an annual
activity required by statute (42 U.S.C.
8629) and Federal regulations (45 CFR
96.92) for the Low Income Home Energy
Assistance Program (LIHEAP).
Submission of the completed report is
one requirement for LIHEAP grantees
applying for Federal LIHEAP block
grant funds.
States, the District of Columbia, and
the Commonwealth of Puerto Rico are
required to report statistics for the
previous Federal fiscal year on:
• Assisted and applicant households,
by type of LIHEAP assistance;
• Assisted and applicant households,
by type of LIHEAP assistance and
poverty level;
• Assisted households receiving only
utility payment assistance;
• Assisted households, regardless of
the type(s) of LIHEAAP assistance;
• Assisted households, by type of
LIHEAP assistance, having at least one
vulnerable member broken out; by a
person at least 60 years or younger,
disabled person, or a child five years
older of younger;
• Assisted households, by type of
LIHEAP assistance, with least one
member age 2 years or under;
• Assisted households, by type of
LIHEAP assistance, with at least one
member ages 3 years through 5 years;
and
• Assisted households, regardless of
the type(s) of LIHEAP assistance, having
at least one member 60 years or older,
disabled, or five years old or younger.
Insular areas (other than the
Commonwealth of Puerto Rico) and
Indian Tribal Grantees are required to
submit data only on the number of
households receiving heating, cooling,
energy crisis, and/or weatherization
benefits.
The information is being collected for
the Department’s annual LIHEAP Report
to Congress. The data also provides
information about the need for LIHEAP
funds. Finally, the data are used in the
calculation of LIHEAP performance
measures under the Government
Performance and Results Act of 1993.
The data elements will allow the
accuracy of measuring LIHEAP targeting
performance and LIHEAP cost
efficiency.
Respondents: State Governments,
Tribal Governments, Insular Areas, the
District of Columbia, and the
Commonwealth of Puerto Rico.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
52
155
52
1
1
1
25
1
13
1,300
155
676
Estimated Total Annual Burden Hours .....................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Assisted Household Report-Long Form ..........................................................
Assisted Household Report-Short Form ..........................................................
Applicant Household Report ............................................................................
........................
........................
........................
2,131
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
VerDate Sep<11>2014
18:05 Feb 26, 2015
Jkt 235001
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0279]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prescription Drug
Marketing Act of 1987; Administrative
Procedures, Policies, and
Requirements
[FR Doc. 2015–04141 Filed 2–26–15; 8:45 am]
AGENCY:
BILLING CODE 4184–01–P
HHS.
PO 00000
ACTION:
Food and Drug Administration,
Notice.
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.
DATES: Fax written comments on the
collection of information by March 30,
2015.
SUMMARY:
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10698
Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices
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:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0435. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Prescription Drug Marketing Act of
1987; Administrative Procedures,
Policies, and Requirements—21 CFR
Part 203—(OMB Control No. 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
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) ...................
mstockstill on DSK4VPTVN1PROD with NOTICES
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) .........................................
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27FEN1
Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / 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; and
(7) to require unauthorized wholesale
10699
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.
In the Federal Register of November
14, 2014 (79 FR 68273), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total annual
respondents
Average burden
per response
Total hours
203.11 Re-importation .................................................
203.30(a)(1) and (b) Drug sample requests ...............
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 ...................................
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
.50 (30 minutes) .....
.06 (4 minutes) ......
.06 (4 minutes) .......
.04 (2 minutes) .......
.03 (2 minutes) .......
.25 (15 minutes) .....
.25 (15 minutes) .....
1 .............................
.08 (5 minutes) ......
1 .............................
1
44,612
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
recordkeeping
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
2,208
5
5
100
1
158,380
158,380
220,800
2,208
.25 (15 minutes) .....
.08 (5 minutes) ......
.50 (30 minutes) .....
40 ...........................
39,595
12,670
110,400
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
2,000
65
3,221
3,221
3,221
1 .............................
40 ...........................
6 .............................
6 .............................
1 .............................
.50 (30 minutes) .....
8 .............................
8 .............................
2,208
3,600
1,200
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
mstockstill on DSK4VPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: February 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–04131 Filed 2–26–15; 8:45 am]
BILLING CODE 4164–01–P
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PO 00000
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]]>Agencies
[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)]
[Notices]
[Pages 10697-10699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-04131]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0279]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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.
DATES: Fax written comments on the collection of information by March
30, 2015.
[[Page 10698]]
ADDRESSES: 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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0435.
Also include the FDA 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: 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 No. 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 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.
------------------------------------------------------------------------
[[Page 10699]]
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.
In the Federal Register of November 14, 2014 (79 FR 68273), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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
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 2,000 .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
----------------------------------------------------------------------------------------------------------
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
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
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........................................ 1,200
records.
203.37(b) Loss or theft of drug samples...... 50 40 2,000 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: February 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-04131 Filed 2-26-15; 8:45 am]
BILLING CODE 4164-01-P
