Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements, 58808-58810 [2017-26933]
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58808
Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
requirements conducted or sponsored
by the Board. Board-approved
collections of information are
incorporated into the official OMB
inventory of currently approved
collections of information. Copies of the
Paperwork Reduction Act Submission,
supporting statements and approved
collection of information instrument(s)
are placed into OMB’s public docket
files. The Federal Reserve may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Final Approval Under OMB Delegated
Authority of the Extension for Three
Years, Without Revision, of the
Following Report
Report title: Reporting Requirements
Associated with Regulation XX
Concentration Limit; Financial
Company (as defined) Report of
Consolidated Liabilities.
Agency form number: FR XX; FR XX–
1.
OMB control number: 7100–0363.
Frequency: Event-generated; annual.
Respondents: Insured depository
institutions, bank holding companies,
foreign banking organizations, savings
and loan holding companies, companies
that control insured depository
institutions, and nonbank financial
companies supervised by the Board;
U.S. and foreign financial companies
that do not otherwise report
consolidated financial information to
the Board or other appropriate Federal
banking agency.
Estimated number of respondents: FR
XX (Section 251.4(b)): 1; FR XX (Section
251.4(c)): 1; FR XX–1: 43.
Estimated average hours per response:
FR XX (Section 251.4(b)): 10, FR XX
(Section 251.4(c)): 10; FR XX–1: 2.
Estimated annual burden hours: FR
XX (Section 251.4(b)): 10; FR XX
(Section 251.4(c)): 10; FR XX–1: 86 (106
total).
General description of report: The
Board adopted Regulation XX to
implement section 14 of the Bank
Holding Company Act of 1956 (BHC
Act), which was added by section 622
of the Dodd-Frank Wall Street Reform
and Consumer Protection Act (DoddFrank Act). Section 14 established a
financial sector concentration limit that
generally prohibits a financial company
from merging or consolidating with, or
otherwise acquiring, another company if
the resulting company’s liabilities upon
consummation would exceed 10 percent
of the aggregate liabilities of all financial
companies. Regulation XX established
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21:28 Dec 13, 2017
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certain reporting requirements for
financial companies. The Board created
the FR XX–1 reporting form to collect
information required to be submitted by
Regulation XX.
Legal authorization and
confidentiality: This information
collection is authorized by section 14 of
the Bank Holding Company Act (12
U.S.C. 1852(d)) and Regulation XX (12
CFR part 251). The obligation of
financial companies to comply with the
consolidated liabilities reporting
requirement is mandatory. Compliance
by financial companies with the
transactional reporting requirements is
required in order to obtain the benefit of
Board consent to consummation of the
transactions.
Section 251.6 and FR XX–1. As noted,
the required reporting of calendar yearend liabilities under section 251.6 of
Regulation XX can be satisfied by many
financial companies through their
continued reporting of consolidated
financial information to the Board or
other appropriate Federal banking
agency though the various reports listed
above. The information collected on
those forms has been the subject of
separate authorization and
confidentiality determinations. With
regard to the collection of the specific
information at issue, calendar year-end
liabilities (including as collected on the
FR XX–1), such information generally is
not considered confidential, but some
information, depending on the
circumstances, may be the type of
confidential commercial and financial
information that may be withheld under
exemption 4 of the Freedom of
Information Act (FOIA) (5 U.S.C
552(b)(4)). As required information, it
may be withheld under exemption 4 on
a case-by-case basis only if public
disclosure could result in substantial
competitive harm to the submitting
institution. Any request from a
submitter for confidential treatment
should be accompanied by a detailed
justification for confidentiality.
Section 251.4. The information
collected under section 251.4 (under
both its prior written consent provision
for individual transactions and the
general consent authority) consists of (1)
a description of the acquisition and (2)
the change in and resultant aggregate
amount of financial company liabilities.
The reported liabilities information, in
like fashion to the liabilities information
reported under section 251.6, generally
is not considered confidential but,
depending on the circumstances, may
be the type of confidential commercial
and financial information that may be
withheld under exemption 4 of FOIA.
The description of the individual
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acquisitions provided under the prior
written consent provisions generally
would not be deemed confidential, but
that some such information may be of
the type that could be withheld under
exemption 4 on a case-by-case basis,
under the standards enumerated above.
Current actions: On August 16, 2017,
the Board published a notice in the
Federal Register (82 FR 38906)
requesting public comment for 60 days
on the extension, without revision, of
the FR XX and FR XX–1. The comment
period for this notice expired on
October 16, 2017. The Board did not
receive any comments. The information
collection will be extended as proposed.
Board of Governors of the Federal Reserve
System, December 11, 2017.
Ann E. Misback,
Secretary of the Board.
[FR Doc. 2017–26962 Filed 12–13–17; 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;
Comment Request; Prescription Drug
Marketing Act of 1987; Administrative
Procedures, Policies, and
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection in the regulations on the
Prescription Drug Marketing Act of
1987; Administrative Procedures,
Policies, and Requirements.
DATES: Submit either electronic or
written comments on the collection of
information by February 12, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
SUMMARY:
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Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices
be submitted on or before February 12,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of February 12, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
sradovich on DSK3GMQ082PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0279 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Prescription Drug Marketing Act of
1987; Administrative Procedures,
Policies, and Requirements.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
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Jkt 244001
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
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58809
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
OMB Control Number 0910–0435—
Extension
This information collection supports
FDA regulations. Specifically,
regulations codified at 21 CFR part 203
implement the Prescription Drug
Marketing Act of 1987 (PDMA). The
PDMA was intended to ensure safe and
effective drug products and to avoid an
unacceptable risk that counterfeit,
adulterated, misbranded, subpotent, or
expired drugs are sold to consumers.
The reporting and recordkeeping
requirements found in the regulations
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
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hospitals or other healthcare 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, or the offer to
sell, purchase, or trade, of prescription
drugs that were purchased by hospitals
or other healthcare entities or that 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 tables below we have listed
specific regulatory provisions that
include information collection.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section/activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
203.11—Reimportation ........................................................
203.30(a)(1) and (b)—Drug sample requests .....................
203.30(a)(3), (a)(4), and (c)—Drug sample receipts ...........
203.31(a)(1) and (b)—Drug sample requests .....................
203.31(a)(3), (a)(4), and (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
0.5
0.06
0.06
0.04
0.03
0.25
0.25
1
0.08
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/activity
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
(in hours)
Total hours
203.23(a) and (b)—Returned drugs ....................................
203.23(c)—Returned drugs documentation .........................
203.30(a)(2) and 203.31(a)(2)—Practitioner verification .....
203.31(d)(1) and (d)(2)—Inventory record and reconciliation report .......................................................................
203.31(d)(4)—Investigation of discrepancies and losses ....
203.31(e)—Representatives lists .........................................
203.34—Administrative systems ..........................................
203.37(a)—Falsification of drug sample records .................
203.37(b)—Loss or theft of drug samples ...........................
203.39(d)—Destroyed or returned drug samples ................
203.39(e)—Donated drug samples ......................................
203.39(f)—Distribution of donated drug samples ................
203.39(g)—Drug samples donated to charitable institutions
203.50(a)—Drug origin statement .......................................
203.50(b)—Drug origin statement retention ........................
203.50(d)—Authorized distributors of record .......................
31,676
31,676
2,208
5
5
100
158,380
158,380
220,800
0.25
0.08
0.5
39,595
12,670
110,400
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
2,000
65
3,221
3,221
3,221
12,500
12,500
691
40
24
1
40
6
6
1
0.5
8
8
0.17
0.5
2
88,320
10,608
2,208
3,600
1,200
12,000
65
1,611
25,768
25,768
2,125
6,250
1,382
Total ..............................................................................
........................
........................
........................
........................
343,570
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection, we have retained the
currently approved estimated burden.
Dated: December 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
sradovich on DSK3GMQ082PROD with NOTICES
[FR Doc. 2017–26933 Filed 12–13–17; 8:45 am]
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]]>Agencies
[Federal Register Volume 82, Number 239 (Thursday, December 14, 2017)]
[Notices]
[Pages 58808-58810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26933]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0279]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prescription Drug Marketing Act of 1987;
Administrative Procedures, Policies, and Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection in the
regulations on the Prescription Drug Marketing Act of 1987;
Administrative Procedures, Policies, and Requirements.
DATES: Submit either electronic or written comments on the collection
of information by February 12, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must
[[Page 58809]]
be submitted on or before February 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 12, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-N-0279 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Prescription Drug Marketing Act
of 1987; Administrative Procedures, Policies, and Requirements.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Prescription Drug Marketing Act of 1987--Administrative Procedures,
Policies, and Requirements
OMB Control Number 0910-0435--Extension
This information collection supports FDA regulations. Specifically,
regulations codified at 21 CFR part 203 implement the Prescription Drug
Marketing Act of 1987 (PDMA). The PDMA was intended to ensure safe and
effective drug products and to avoid an unacceptable risk that
counterfeit, adulterated, misbranded, subpotent, or expired drugs are
sold to consumers. The reporting and recordkeeping requirements found
in the regulations 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
[[Page 58810]]
hospitals or other healthcare 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, or the offer to sell, purchase, or trade,
of prescription drugs that were purchased by hospitals or other
healthcare entities or that 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 tables below we have listed specific regulatory provisions
that include information collection.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
21 CFR section/activity respondents responses per responses response (in Total hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
203.11--Reimportation........... 1 1 1 0.5 1
203.30(a)(1) and (b)--Drug 61,961 12 743,532 0.06 44,612
sample requests................
203.30(a)(3), (a)(4), and (c)-- 61,961 12 743,532 0.06 44,612
Drug sample receipts...........
203.31(a)(1) and (b)--Drug 232,355 135 31,367,925 0.04 1,254,717
sample requests................
203.31(a)(3), (a)(4), and (c)-- 232,355 135 31,367,925 0.03 941,038
Drug sample receipts...........
203.37(a)--Falsification of 50 4 200 0.25 50
records........................
203.37(b)--Loss or theft of 50 40 2,000 0.25 500
samples........................
203.37(c)--Convictions.......... 1 1 1 1 1
203.37(d)--Contact person....... 50 1 50 0.08 4
203.39(g)--Reconciliation report 1 1 1 1 1
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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\
----------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per
21 CFR section/activity recordkeepers records per records recordkeeping Total hours
recordkeeper (in hours)
----------------------------------------------------------------------------------------------------------------
203.23(a) and (b)--Returned 31,676 5 158,380 0.25 39,595
drugs..........................
203.23(c)--Returned drugs 31,676 5 158,380 0.08 12,670
documentation..................
203.30(a)(2) and 203.31(a)(2)-- 2,208 100 220,800 0.5 110,400
Practitioner verification......
203.31(d)(1) and (d)(2)-- 2,208 1 2,208 40 88,320
Inventory record and
reconciliation report..........
203.31(d)(4)--Investigation of 442 1 442 24 10,608
discrepancies 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 50 4 200 6 1,200
sample records.................
203.37(b)--Loss or theft of drug 50 40 2,000 6 12,000
samples........................
203.39(d)--Destroyed or returned 65 1 65 1 65
drug samples...................
203.39(e)--Donated drug samples. 3,221 1 3,221 0.5 1,611
203.39(f)--Distribution of 3,221 1 3,221 8 25,768
donated drug samples...........
203.39(g)--Drug samples donated 3,221 1 3,221 8 25,768
to charitable institutions.....
203.50(a)--Drug origin statement 125 100 12,500 0.17 2,125
203.50(b)--Drug origin statement 125 100 12,500 0.5 6,250
retention......................
203.50(d)--Authorized 691 1 691 2 1,382
distributors of record.........
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Total....................... .............. .............. .............. .............. 343,570
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection, we have retained
the currently approved estimated burden.
Dated: December 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26933 Filed 12-13-17; 8:45 am]
BILLING CODE 4164-01-P
