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, 60501-60503 [2011-25117]
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Federal Register / Vol. 76, No. 189 / Thursday, September 29, 2011 / Notices
Dated: September 21, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
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 e-mailed 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:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@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.
[FR Doc. 2011–25012 Filed 9–28–11; 8:45 am]
BILLING CODE 4160–18–P
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:
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) (Pub. L. 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,
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
(the PRA).
DATES: Fax written comments on the
collection of information by October 31,
2011.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
60501
misbranded, subpotent, or expired drugs
are sold.
PDMA was enacted by Congress
because there were insufficient
safeguards in the drug distribution
system to prevent the introduction and
retail sale of substandard, ineffective, or
counterfeit drugs, and that a wholesale
drug diversion submarket had
developed that prevented effective
control over the true sources of drugs.
Congress found that large amounts of
drugs had been reimported into the
United States as U.S. goods returned
causing a health and safety risk to U.S.
consumers because the drugs may
become subpotent or adulterated during
foreign handling and shipping. Congress
also found that a ready market for
prescription drug reimports had been
the catalyst for a continuing series of
frauds against U.S. manufacturers and
had provided the cover for the
importation of foreign counterfeit drugs.
Congress also determined that the
system of providing drug samples to
physicians through manufacturers’
representatives had resulted in the sale
to consumers of misbranded, expired,
and adulterated pharmaceuticals.
The bulk resale of below-wholesale
priced prescription drugs by health care
entities for ultimate sale at retail also
helped to fuel the diversion market and
was an unfair form of competition to
wholesalers and retailers who had to
pay otherwise prevailing market prices.
FDA is requesting OMB approval for
the following reporting and
recordkeeping requirements:
TABLE 1—REPORTING REQUIREMENTS
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) ...........................................
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.
203.31(a)(3), (a)(4), and (c) ................................
203.37(a) .............................................................
203.37(b) .............................................................
203.37(c) .............................................................
203.37(d) .............................................................
203.39(g) .............................................................
tkelley on DSKG8SOYB1PROD with NOTICES
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.
203.31(d)(1) and (d)(2) .......................................
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29SEN1
60502
Federal Register / Vol. 76, No. 189 / Thursday, September 29, 2011 / Notices
TABLE 2—RECORDKEEPING REQUIREMENTS—Continued
21 CFR Section
Requirement
203.31(d)(4) ........................................................
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(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) .............................................................
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.
In the Federal Register of June 6, 2011
(76 FR 32362), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
We received one comment. The
comment did not pertain to the
information collection discussed in the
June 2011 Federal Register notice, but
commended the use of electronic and
automated health information solutions
to reduce costs and improve health care
efficiency.
FDA Response: There were no issues
raised in the comment to be resolved.
FDA estimates the burden of this
collection of information as follows:
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
respondents
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
Total ..............................................................................
........................
........................
........................
1 There
Average
burden
per
response
(in hours)
.5
.06
.06
.04
.03
.25
.25
Total hours
.08
1
.5
44,612
44,612
1,254,717
941,038
50
500
1
4
1
........................
2,285,535.5
1
are no operating and maintenance costs or capital costs associated with this collection of information.
tkelley on DSKG8SOYB1PROD with NOTICES
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN
Number of
recordkeepers
21 CFR Section
203.23(a) and (b) .................................................................
203.23(c) ..............................................................................
203.30(a)(2) and 203.31(a)(2) .............................................
VerDate Mar<15>2010
15:29 Sep 28, 2011
Jkt 223001
PO 00000
Frm 00056
Number of
records per
recordkeeper
31,676
31,676
2,208
Fmt 4703
Sfmt 4703
5
5
100
Total annual
records
158,380
158,380
220,800
E:\FR\FM\29SEN1.SGM
29SEN1
Average
burden per
recordkeeping
(in hours)
.25
.08
.50
Total hours
39,595
12,670
110,400
Federal Register / Vol. 76, No. 189 / Thursday, September 29, 2011 / Notices
60503
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN—Continued
21 CFR Section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
(in hours)
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) ..............................................................................
Total ..............................................................................
2,208
442
2,208
90
50
50
65
3,221
3,221
3,221
125
125
691
........................
1
1
1
1
4
40
1
1
1
1
100
100
1
........................
2,208
442
2,208
90
200
2000
65
3,221
3,221
3,221
12,500
12,500
691
........................
40
24
1
40
6
6
1
.50
8
8
.17
.50
2
........................
1 There
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0023]
Guidance for Industry on Target
Animal Safety and Effectiveness
Protocol Development and
Submission; Availability
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
(#215) entitled ‘‘Target Animal Safety
and Effectiveness Protocol Development
and Submission.’’ The purpose of this
document is to provide sponsors
guidance in preparation of study
protocols for review by the Center for
Veterinary Medicine, Office of New
Animal Drug Evaluation. The
recommendations included in this
guidance are intended to reduce the
time to protocol concurrence.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Communications Staff (HFV–12), Center
for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
tkelley on DSKG8SOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:29 Sep 28, 2011
Jkt 223001
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Angela Clarke, Center for Veterinary
Medicine (HFV–112), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8318;
e-mail: angela.clarke@fda.gov.
SUPPLEMENTARY INFORMATION:
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
I. Background
[FR Doc. 2011–25117 Filed 9–28–11; 8:45 am]
ACTION:
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
332,769
are no operating and maintenance costs or capital costs associated with this collection of information.
Dated: September 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
AGENCY:
Total hours
IV. Comments
In the Federal Register of February 3,
2011 (76 FR 6143), FDA published the
notice of availability for a draft guidance
entitled ‘‘Target Animal Safety and
Effectiveness Protocol Development and
Submission,’’ giving interested persons
until April 19, 2011, to comment on the
draft guidance. FDA received one
comment on the draft guidance and that
comment was considered as the
guidance was finalized. Changes
include editorial revisions to improve
clarity regarding how and when data
collection forms and standard operating
procedures should be included with the
protocol submission. The guidance
announced in this notice finalizes the
draft guidance dated February 2, 2011.
II. Significance of Guidance
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on the topic. It does not
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
this guidance have been approved under
OMB control no. 0910–0032.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
V. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
E:\FR\FM\29SEN1.SGM
29SEN1
]]>Agencies
[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Pages 60501-60503]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25117]
-----------------------------------------------------------------------
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 (the PRA).
DATES: Fax written comments on the collection of information by October
31, 2011.
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 e-mailed 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: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
juanmanuel.vilela@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 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) (Pub. L. 100-293). PDMA was intended to ensure that drug
products purchased by consumers are safe and effective and to avoid an
unacceptable risk that counterfeit, adulterated, misbranded, subpotent,
or expired drugs are sold.
PDMA was enacted by Congress because there were insufficient
safeguards in the drug distribution system to prevent the introduction
and retail sale of substandard, ineffective, or counterfeit drugs, and
that a wholesale drug diversion submarket had developed that prevented
effective control over the true sources of drugs.
Congress found that large amounts of drugs had been reimported into
the United States as U.S. goods returned causing a health and safety
risk to U.S. consumers because the drugs may become subpotent or
adulterated during foreign handling and shipping. Congress also found
that a ready market for prescription drug reimports had been the
catalyst for a continuing series of frauds against U.S. manufacturers
and had provided the cover for the importation of foreign counterfeit
drugs.
Congress also determined that the system of providing drug samples
to physicians through manufacturers' representatives had resulted in
the sale to consumers of misbranded, expired, and adulterated
pharmaceuticals.
The bulk resale of below-wholesale priced prescription drugs by
health care entities for ultimate sale at retail also helped to fuel
the diversion market and was an unfair form of competition to
wholesalers and retailers who had to pay otherwise prevailing market
prices.
FDA is requesting OMB approval for the following reporting and
recordkeeping requirements:
Table 1--Reporting Requirements
------------------------------------------------------------------------
21 CFR Section Requirement
------------------------------------------------------------------------
203.11....................... Applications for reimportation 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.
[[Page 60502]]
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.
In the Federal Register of June 6, 2011 (76 FR 32362), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received one comment. The comment did not
pertain to the information collection discussed in the June 2011
Federal Register notice, but commended the use of electronic and
automated health information solutions to reduce costs and improve
health care efficiency.
FDA Response: There were no issues raised in the comment to be
resolved.
FDA estimates the burden of this collection of information as
follows:
Table 3--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
21 CFR Section respondents responses per respondents response (in Total hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
203.11............................ 1 1 1 .5 .5
203.30(a)(1) and (b).............. 61,961 12 743,532 .06 44,612
203.30(a)(3), (a)(4), and (c)..... 61,961 12 743,532 .06 44,612
203.31(a)(1) and (b).............. 232,355 135 31,367,925 .04 1,254,717
203.31(a)(3), (a)(4), and (c)..... 232,355 135 31,367,925 .03 941,038
203.37(a)......................... 50 4 200 .25 50
203.37(b)......................... 50 40 2,000 .25 500
203.37(c)......................... 1 1 1 1 1
203.37(d)......................... 50 1 50 .08 4
203.39(g)......................... 1 1 1 1 1
-----------------------------------------------------------------------------
Total......................... .............. .............. .............. ............. 2,285,535.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs or capital costs associated with this collection of
information.
Table 4--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per
21 CFR Section recordkeepers records per records recordkeeping Total hours
recordkeeper (in hours)
----------------------------------------------------------------------------------------------------------------
203.23(a) and (b)............... 31,676 5 158,380 .25 39,595
203.23(c)....................... 31,676 5 158,380 .08 12,670
203.30(a)(2) and 203.31(a)(2)... 2,208 100 220,800 .50 110,400
[[Page 60503]]
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 2000 6 1,200
203.39(d)....................... 65 1 65 1 65
203.39(e)....................... 3,221 1 3,221 .50 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 .17 2,125
203.50(b)....................... 125 100 12,500 .50 6,250
203.50(d)....................... 691 1 691 2 1,382
Total....................... .............. .............. .............. .............. 332,769
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\1\ There are no operating and maintenance costs or capital costs associated with this collection of
information.
Dated: September 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25117 Filed 9-28-11; 8:45 am]
BILLING CODE 4160-01-P
