Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements, 24127-24128 [2018-11113]
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Federal Register / Vol. 83, No. 101 / Thursday, May 24, 2018 / Notices
24127
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
21 CFR section; activity
507.7(e)(1); change labels on products with labels .....................
507.7(e)(2); change address on labeling (sales documents) for
qualified facilities.
507.25(a)(2); animal food, including raw materials, other ingredients, and rework, is accurately identified.
507.28(b); holding and distribution of human food byproducts for
use as animal food.
Total .......................................................................................
1
Average
burden per
response
Total annual
responses
1,526
1,329
4
1
6,104
1,329
330
312
40,798
....................
Total hours
1 ............................
1 ............................
6,104
1,329
102,960
0.01 (36 seconds)
1,030
2
81,596
0.25 (15 minutes)
20,399
....................
....................
...............................
29,687
There are no capital costs or operating and maintenance costs associated with this collection of information.
These figures are based on our
regulatory impact analysis in support of
the final rule on Preventive Controls for
Food for Animals, which published in
the Federal Register of September 17,
2015 (80 FR 56170). Using Agency data
we estimated the number of animal food
facilities that we believe are subject to
the regulations. We base our estimate of
the time necessary for the individual
reporting, recordkeeping, and thirdparty disclosure activities on our
experience with similar information
collections.
Dated: May 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–11114 Filed 5–23–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prescription Drug
Marketing; Administrative Procedures,
Policies, and Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 June 25,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
VerDate Sep<11>2014
18:10 May 23, 2018
Jkt 244001
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:
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: 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
[Docket No. FDA–2011–N–0279]
sradovich on DSK3GMQ082PROD with NOTICES
Number of
responses
per
respondent
OMB Control Number 0910–0435—
Extension
This information collection supports
FDA regulations codified at part 203 (21
CFR part 203) implementing 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
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
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 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 Federal Register of December
14, 2017 (82 FR 58808), we published a
notice soliciting public comment of the
information collection. One caller
responded to the notice asking about the
impact the Drug Supply Chain Security
Act (DSCSA) (Title II of the Drug
Quality Security Act of 2013) has on the
information collection. We note that the
Agency is currently proposing to amend
its regulations at part 203 to reflect
changes resulting from enactment of the
DSCSA (RIN 0910–AH56). While we
expect these changes will result in a
reduction of burden associated with the
information collection, current
regulations and associated information
collection requirements remain in effect.
Upon finalization of rulemaking, we
will revise the information collection
accordingly.
We therefore estimate the burden for
the information collection as follows:
E:\FR\FM\24MYN1.SGM
24MYN1
24128
Federal Register / Vol. 83, No. 101 / Thursday, May 24, 2018 / Notices
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
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 (30 minutes)
0.06 (4 minutes)
0.06 (4 minutes)
0.04 (2.5 minutes)
0.03 (2 minutes)
0.25 (15 minutes)
0.25 (15 minutes)
1 ..........................
0.08 (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/Activity
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 (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
0.25 (15 minutes)
0.08 (5 minutes)
0.5 (30 minutes)
40 ........................
39,595
12,670
110,400
88,320
442
2,208
90
50
50
65
3,221
3,221
3,221
1
1
1
4
40
1
1
1
1
442
2,208
90
200
2,000
65
3,221
3,221
3,221
24 ........................
1 ..........................
40 ........................
6 ..........................
6 ..........................
1 ..........................
0.5 (30 minutes)
8 ..........................
8 ..........................
10,608
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
0.17 (10 minutes)
0.5 (30 minutes)
2 ..........................
2,125
6,250
1,382
Total .........................................................................
........................
........................
........................
.............................
343,570
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of Agency data, we
retain the currently approved burden
estimate for the information collection,
as reflected in tables 1 and 2 above.
Dated: May 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–11113 Filed 5–23–18; 8:45 am]
BILLING CODE 4164–01–P
sradovich on DSK3GMQ082PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
18:10 May 23, 2018
Jkt 244001
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled ‘‘Anthrax:
Developing Drugs for Prophylaxis of
Inhalational Anthrax.’’ The purpose of
this guidance is to assist sponsors in the
development of new drugs for the
prophylaxis of inhalational anthrax.
This guidance finalizes the draft
guidance of the same name issued on
February 16, 2016.
SUMMARY:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
Food and Drug Administration,
VerDate Sep<11>2014
Electronic Submissions
The announcement of the
guidance is published in the Federal
Register on May 24, 2018.
Anthrax: Developing Drugs for
Prophylaxis of Inhalational Anthrax;
Guidance for Industry; Availability
HHS.
Notice of availability.
DATES:
[Docket No. FDA–2016–D–0412]
AGENCY:
ACTION:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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
E:\FR\FM\24MYN1.SGM
24MYN1
]]>Agencies
[Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)]
[Notices]
[Pages 24127-24128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11113]
-----------------------------------------------------------------------
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; 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 June
25, 2018.
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 [email protected]. 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: 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: 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
OMB Control Number 0910-0435--Extension
This information collection supports FDA regulations codified at
part 203 (21 CFR part 203) implementing 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 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 Federal Register of December 14, 2017 (82 FR 58808), we
published a notice soliciting public comment of the information
collection. One caller responded to the notice asking about the impact
the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug
Quality Security Act of 2013) has on the information collection. We
note that the Agency is currently proposing to amend its regulations at
part 203 to reflect changes resulting from enactment of the DSCSA (RIN
0910-AH56). While we expect these changes will result in a reduction of
burden associated with the information collection, current regulations
and associated information collection requirements remain in effect.
Upon finalization of rulemaking, we will revise the information
collection accordingly.
We therefore estimate the burden for the information collection as
follows:
[[Page 24128]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/a ctivity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
203.11--Reimportation.......... 1 1 1 0.5 (30 1
minutes).
203.30(a)(1) and (b)--Drug 61,961 12 743,532 0.06 (4 44,612
sample requests. minutes).
203.30(a)(3), (a)(4), and (c)-- 61,961 12 743,532 0.06 (4 44,612
Drug sample receipts. minutes).
203.31(a)(1) and (b)--Drug 232,355 135 31,367,925 0.04 (2.5 1,254,717
sample requests. minutes).
203.31(a)(3), (a)(4), and (c)-- 232,355 135 31,367,925 0.03 (2 941,038
Drug sample receipts. minutes).
203.37(a)--Falsification of 50 4 200 0.25 (15 50
records. minutes).
203.37(b)--Loss or theft of 50 40 2,000 0.25 (15 500
samples. minutes).
203.37(c)--Convictions......... 1 1 1 1.............. 1
203.37(d)--Contact person...... 50 1 50 0.08 (5 4
minutes).
203.39(g)--Reconciliation 1 1 1 1.............. 1
report.
--------------------------------------------------------------------------------
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 Average burden
21 CFR Section/Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
203.23(a) and (b)--Returned 31,676 5 158,380 0.25 (15 39,595
drugs. minutes).
203.23(c)--Returned drugs 31,676 5 158,380 0.08 (5 12,670
documentation. minutes).
203.30(a)(2) and 203.31(a)(2)-- 2,208 100 220,800 0.5 (30 110,400
Practitioner verification. minutes).
203.31(d)(1) and (2)--Inventory 2,208 1 2,208 40............. 88,320
record and reconciliation
report.
203.31(d)(4)--Investigation of 442 1 442 24............. 10,608
discrepancies and losses.
203.31(e)--Representatives 2,208 1 2,208 1.............. 2,208
lists.
203.34--Administrative systems. 90 1 90 40............. 3,600
203.37(a)--Falsification of 50 4 200 6.............. 1,200
drug sample records.
203.37(b)--Loss or theft of 50 40 2,000 6.............. 12,000
drug samples.
203.39(d)--Destroyed or 65 1 65 1.............. 65
returned drug samples.
203.39(e)--Donated drug samples 3,221 1 3,221 0.5 (30 1,611
minutes).
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 125 100 12,500 0.17 (10 2,125
statement. minutes).
203.50(b)--Drug origin 125 100 12,500 0.5 (30 6,250
statement retention. minutes).
203.50(d)--Authorized 691 1 691 2.............. 1,382
distributors of record.
--------------------------------------------------------------------------------
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 Agency data, we retain the currently approved
burden estimate for the information collection, as reflected in tables
1 and 2 above.
Dated: May 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11113 Filed 5-23-18; 8:45 am]
BILLING CODE 4164-01-P
