Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification, 62585-62589 [2018-26295]
Download as PDF
<![CDATA[
62585
Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR section
FDA form No.
807.22(b)(2) 3—Other Updates of Registration .................................................
807.22(b)(3) 3—Annual Update of Listing
Information ............................................
807.26(e) 3—Labeling and Advertisement
Submitted at FDA Request ..................
807.34(a) 2—Initial Registration and Listing when Electronic Filing Waiver
Granted .................................................
807.34(a) 3—Annual Registration and
Listing when Electronic Filing Waiver
Granted .................................................
807.40(b)(2) 3—Annual Update of US
Agent Information .................................
807.40(b)(3) 3—US Agent Responses to
FDA Requests for Information .............
807.41(a) 3—Identification of Initial Importers by Foreign Establishments ......
807.41(b) 3—Identification of Other Parties that Facilitate Import by Foreign
Establishments .....................................
Annual
frequency
per response
Number of
respondents
Total annual
responses
Hours per
response
Total hours
3673
2,687
1
2,687
0.5
1,344
3673
22,607
1
22,607
0.5
11,304
........................
71
1
71
1
71
........................
1
1
1
1
1
........................
1
1
1
1
1
3673
1,615
1
1,615
0.5
808
3673
1,535
1
1,535
0.25
384
3673
12,983
1
12,983
0.5
6,492
3673
12,983
1
12,983
0.5
6,492
Total One Time Burden ....................
........................
........................
........................
........................
........................
14,975
Total Recurring Burden .............
........................
........................
........................
........................
........................
39,173
1 Totals
are rounded to the nearest whole number.
Burden—Firm only provides initially.
Burden—Firm is required to review annually.
2 One-Time
3 Recurring
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Number of
respondents
21 CFR section
Annual
frequency per
recordkeeper
Total annual
records
Hours per
record
Total hours
807.25(d) 2—List of Officers, Directors, and Partners .........
22,338
1
22,338
.25
(15 minutes)
5,585
807.26 2—Labeling and Advertisements Available for Review ..................................................................................
17,032
4
68,128
.5
(30 minutes)
34,064
Total ..............................................................................
........................
........................
........................
........................
39,649
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
burden—Firm is required to keep records.
2 Recurring
The following adjustments and
program changes resulted in a 5,672hour decrease to the overall total hour
burden estimate for this information
collection request.
• We adjusted the number of
respondents based on updated
registration and listing data.
• In the reporting burden table, we
corrected the table footnotes to
accurately indicate whether the
information collection (IC) is a one-time
or reoccurring burden.
• We also adjusted some of the IC
descriptions in the table for increased
clarity.
• We updated our estimate of Hours
per Response for ‘‘807.22(a) Initial
Registration and Listing’’ (+ 0.5 hours),
‘‘807.22(b)(1) Annual Registration’’
(¥ 0.25 hours), and ‘‘807.22(b)(3)
VerDate Sep<11>2014
19:26 Dec 03, 2018
Jkt 247001
Annual Update of Listing Information’’
(¥ 0.25 hours). Based on our review of
the program, we believe these changes
to the burden estimate will more
accurately reflect the current
preparation time for these ICs.
Dated: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26303 Filed 12–3–18; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0609]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Drug Supply Chain
Security Act Implementation:
Identification of Suspect Product and
Notification
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
Frm 00026
Fmt 4703
Sfmt 4703
E:\FR\FM\04DEN1.SGM
04DEN1
62586
Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
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 January 3,
2019.
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 0910–0806. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, 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.
Guidance for Industry: Drug Supply
Chain Security Act Implementation:
Identification of Suspect Product and
Notification
OMB Control Number 0910–0806—
Extension
This information collection supports
the previously captioned Agency
guidance and associated Form FDA
3911. The Drug Supply Chain Security
Act (DSCSA) (Title II of Pub. L. 113–54)
added new section 582(h)(2) to the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360eee–1(h)(2)),
requiring FDA to issue guidance to aid
trading partners in identifying a suspect
product and terminating a notification
regarding an illegitimate product and,
for a manufacturer, a product with a
high risk of illegitimacy. Suspect
product is defined in section 581(21) of
the FD&C Act (21 U.S.C. 360eee(21)), as
a product for which there is reason to
believe it: (1) Is potentially counterfeit,
diverted, or stolen; (2) is potentially
intentionally adulterated such that the
product would result in serious adverse
health consequences or death to
humans; (3) is potentially the subject of
a fraudulent transaction; or (4) appears
otherwise unfit for distribution such
that the product would result in serious
adverse health consequences or death to
humans.
VerDate Sep<11>2014
17:36 Dec 03, 2018
Jkt 247001
Beginning January 1, 2015, section
582 of the FD&C Act requires certain
trading partners, upon determining that
a product in their possession or control
is a suspect product, to quarantine the
product while they promptly conduct
an investigation to determine whether
the product is an illegitimate product.
Illegitimate product is defined in
section 581(8) of the FD&C Act as a
product for which credible evidence
shows that it: (1) Is counterfeit, diverted,
or stolen; (2) is intentionally adulterated
such that the product would result in
serious adverse health consequences or
death to humans; (3) is the subject of a
fraudulent transaction; or (4) appears
otherwise unfit for distribution such
that the product would be reasonably
likely to result in serious adverse health
consequences or death to humans. Also
beginning January 1, 2015, trading
partners must, upon determining that a
product in their possession or control is
illegitimate, notify FDA and all
immediate trading partners that they
have reason to believe they may have
received the illegitimate product not
later than 24 hours after making the
determination. Under section
582(b)(4)(B)(ii)(II) of the FD&C Act,
manufacturers are additionally required
to notify FDA and any immediate
trading partners that they believe may
possess a product manufactured by or
purportedly manufactured by the
manufacturer not later than 24 hours
after the determination is made or being
notified by FDA or a trading partner that
the product has a high risk of
illegitimacy.
Under section 202 of the DSCSA,
manufacturers, repackagers, wholesale
distributors, and dispensers (e.g.,
pharmacies) must: (1) Notify FDA when
they have determined that a product in
their possession or control is
illegitimate (and, for manufacturers,
when they have determined or been
notified by FDA or a trading partner that
a product has a high risk of
illegitimacy); (2) notify certain
immediate trading partners about an
illegitimate product that they may have
received (and, for manufacturers, that a
product has a high risk of illegitimacy);
(3) terminate notifications regarding
illegitimate products (and, for
manufacturers, a product with a high
risk of illegitimacy), in consultation
with FDA, when the notifications are no
longer necessary; and (4) notify
immediate trading partners when the
notifications are terminated. Trading
partners should use Form FDA 3911 to
submit notifications and requests for
terminations of notifications to FDA.
Form FDA 3911 is available on FDA’s
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
web page (https://
www.accessdata.fda.gov/scripts/cder/
email/drugnotification.cfm).
A. Notifications to FDA
Under section 582(b)(4)(B)(ii)(I),
(c)(4)(B)(ii), (d)(4)(B)(ii), and (e)(4)(B)(ii)
of the FD&C Act, as amended by the
DSCSA, and beginning not later than
January 1, 2015, a manufacturer,
repackager, wholesale distributor, or
dispenser who determines that a
product in its possession or control is
illegitimate must notify FDA of that
determination not later than 24 hours
after the determination is made. In
addition, section 582(b)(4)(B)(ii)(II) of
the FD&C Act requires manufacturers to
notify FDA when a manufacturer
determines that a product poses a high
risk of illegitimacy.
We originally estimated that all
manufacturers, repackagers, wholesale
distributors, and dispensers would
collectively submit 5,000 notifications
per year. This estimate included the
notifications by trading partners that
have determined that illegitimate
product is in their possession or control,
as well as notifications by
manufacturers that have determined a
product poses a high risk of
illegitimacy. As discussed in our
Federal Register notice of June 11, 2014
(79 FR 33564), the estimate was based
on our experience with field alert
reports (Form FDA 3331) that holders of
approved drug applications are required
to submit for certain drug quality issues
(21 CFR 314.81(b)(1)) and with reports
of the falsification of drug sample
records, diversion, loss, and known
theft of prescription drug samples as
currently required under § 203.37 (21
CFR 203.37). Upon evaluation of the
number of notifications we received for
fiscal years 2016 and 2017, however, we
are lowering our estimate to 150
notifications.
We are also combining the estimates
for manufacturers and repackagers
because FDA’s establishment and drug
product listing database indicates that
many companies perform activities of
both manufacturers and repackagers.
Although the DSCSA specifically
defines dispensers, for estimation
purposes, we are using estimates for
pharmacies in general terms based on
those that must comply with the new
requirements under section 582(d) of
the FD&C Act.
Because manufacturers, repackagers,
and wholesale distributors are
collectively responsible for prescription
drugs from the point of manufacturing
through distribution in the drug supply
chain, we assume that most
notifications of illegitimate products are
E:\FR\FM\04DEN1.SGM
04DEN1
Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
submitted by these three trading
partners. The total number of
respondents is comprised of 80 percent
manufacturers (120), 15 percent
wholesale distributors (22), and 5
percent pharmacies (8).
We estimate that the number of
annual notifications will vary from 0 to
2 for manufacturers/repackagers, as well
as from pharmacies, with the vast
majority of companies making no
notifications. Although FDA’s
establishment and drug product listing
database currently contains registrations
for approximately 6,500 manufacturers
and repackagers, we estimate that
approximately 120 manufacturers/
repackagers will notify us of illegitimate
products an average of one time per
year. Although we estimate
approximately 69,000 pharmacy sites in
the United States, based on data from
the National Association of Chain Drug
Stores, the National Community
Pharmacists Association, and the
American Hospital Association, we
estimate that approximately 8
pharmacies will notify FDA of
illegitimate product an average of one
time per year. According to the
Healthcare Distribution Alliance
(formerly known as Healthcare
Distribution Management Association),
approximately 30 wholesale distributors
are responsible for over 90 percent of
drug distributions; based on sales and
because FDA is estimating that over
2,200 small wholesale distributors
might be responsible for the remaining
10 percent of drug sales, we estimate
that wholesale distributors will be
responsible for making about an average
of 1 notification per year to account for
the estimated 22 notifications that FDA
will receive regarding illegitimate
product. Each notification should
include information about the person or
entity initiating the notification, the
product determined to be illegitimate or
having a high risk of illegitimacy, and
a description of the circumstances
surrounding the event that prompted
the notification. We estimate that each
notification will take about 1 hour, as
reflected in table 1.
B. Notifications to Trading Partners of
an Illegitimate Product or Product With
a High Risk of Illegitimacy
Under section 582(b)(4)(B)(ii)(I),
(c)(4)(B)(ii), (d)(4)(B)(ii), and (e)(4)(B)(ii)
of the FD&C Act, a trading partner who
determines that a product in its
possession is illegitimate must also
notify all immediate trading partners
that they believe may have received
such illegitimate product not later than
24 hours after the determination is
made. In addition, under section
VerDate Sep<11>2014
17:36 Dec 03, 2018
Jkt 247001
582(b)(4)(B)(ii)(II) of the FD&C Act, a
manufacturer is required to notify all
immediate trading partners that the
manufacturer believes may possess a
product manufactured by or purported
to be manufactured by the manufacturer
not later than 24 hours after the
determination is made or being notified
by FDA or a trading partner that the
product has a high risk of illegitimacy.
Because the extent of distribution of
any illegitimate product is likely to vary
from one situation to another, we
assume a wide distribution of each
illegitimate product. We estimate that,
for each notification made by a
manufacturer or repackager to FDA,
approximately 30 trading partners
(based on the number of distributors)
will also be notified. This results in
approximately 3,600 notifications
annually to trading partners of
manufacturers/repackagers. This
estimate includes the notifications by
manufacturers and repackagers who
have determined that illegitimate
product is in their possession or control,
as well as notifications by
manufacturers that have determined
that a product poses a high risk of
illegitimacy.
We estimate that a large wholesale
distributor may have up to 4,500 trading
partners, but a small wholesale
distributor may have 200 trading
partners, for an average of
approximately 2,350. We originally
estimated that a wholesale distributor
would notify all 2,350 trading partners
for each of the illegitimate products
identified. However, we are lowering
our estimate as a result of our
experience with the collection and
informal feedback from industry to
reflect that 22 respondents will make
1,175 disclosures for a total of 25,850
disclosures annually; and that each
disclosure will require approximately
12 minutes, for a total of 5,170 hours
annually.
We estimate that a pharmacy
purchases prescription drugs from an
average of two wholesale distributors.
Therefore, a pharmacy would notify 2
trading partners for each of the 8
illegitimate products identified,
resulting in approximately 16
notifications annually to pharmacy
trading partners.
Manufacturers/repackagers, wholesale
distributors, and pharmacies may notify
their trading partners using existing
systems and processes used for similar
types of communications. Such
communications may include, but are
not limited to, posting notifications on
a company website, sending an email,
telephoning, or mailing or faxing a letter
or notification. The information
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
62587
contained in the notification to the
immediate trading partner should be the
same as or based on the notification that
was already submitted to FDA. We
estimate that, for all trading partners,
each notification of immediate trading
partners will take approximately 0.2
hour (12 minutes). The estimated total
burden hours that manufacturers/
repackagers, wholesale distributors, and
pharmacies will take to notify trading
partners is approximately 5,893 hours
annually, as reflected in table 2.
C. Consultations With FDA and
Termination of Notification
Section 582(b)(4)(B)(iv), (c)(4)(B)(iv),
(d)(4)(B)(iv), and (e)(4)(B)(iv) of the
FD&C Act requires that a trading partner
who determines, in consultation with
FDA, that a notification made under
section 582(b)(4)(B)(ii), (c)(4)(B)(ii),
(d)(4)(B)(ii), or (e)(4)(B)(ii) is no longer
necessary must terminate the
notification. The guidance for industry
sets forth the process by which trading
partners should consult with FDA to
terminate notifications that are no
longer necessary.
Each request for termination of
notification must include information
about the person or entity initiating the
request for termination, the illegitimate
product or product with a high risk of
illegitimacy, the notification that was
issued, and an explanation about what
actions have taken place or what
information has become available that
make the notification no longer
necessary. Trading partners should also
include the FDA-assigned incident
number associated with the initial
notification on the request for
termination. The request for a
termination will be viewed as a request
for consultation with FDA. We estimate
that the same amount of time will be
required to provide the information
necessary to request termination as is
required to make the notification. The
time required to investigate and resolve
an illegitimate product notification will
vary, but we assume that each
notification will eventually be
terminated. We assume that the number
of requests for termination of a
notification per year will be the same as
the original number of notifications for
a given year. The estimated total burden
hours of making requests for
termination of notifications to FDA is
150 hours annually, as reflected in
table 3.
D. Notifications to Trading Partners
That a Notification Has Been
Terminated
Section 582(b)(4)(B)(iv), (c)(4)(B)(iv),
(d)(4)(B)(iv), and (e)(4)(B)(iv) of the
E:\FR\FM\04DEN1.SGM
04DEN1
62588
Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
FD&C Act requires that a trading partner
who, in consultation with FDA,
terminates a notification made under
section 582(b)(4)(B)(ii)(I) or (II),
(c)(4)(B)(ii), (d)(4)(B)(ii), or (e)(4)(B)(ii)
must also promptly inform previouslynotified immediate trading partners that
the notification has been terminated. We
estimate that the burden for notifying
trading partners of an illegitimate
product and the number of trading
partners notified will be the same as the
estimates for notification of termination.
The estimated total burden hours of
notifying trading partners that the
notification is terminated is
approximately 5,893 hours annually, as
reflected in table 4.
In the Federal Register of September
6, 2018 (83 FR 45254), 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—NOTIFICATIONS TO FDA 1
Number of
respondents
Respondent description
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Manufacturers and Repackagers .........................
Wholesale Distributors .........................................
Dispensers ...........................................................
120
22
8
1
1
1
120
22
8
1 ....................................
1 ....................................
1 ....................................
120
22
8
Total ..............................................................
........................
........................
........................
.......................................
150
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR NOTIFICATIONS TO TRADING PARTNERS OF AN
ILLEGITIMATE PRODUCT 1
Number of
respondents
Respondent description
Number of
disclosures
per
respondent
Average
burden per
disclosure
Total annual
disclosures
Total hours
Manufacturers and Repackagers .........................
Wholesale Distributors ..........................................
Dispensers ............................................................
120
22
8
30
1,175
2
3,600
25,850
16
0.20 (12 minutes) .........
0.20 (12 minutes) .........
0.20 (12 minutes) .........
720
5,170
3
Total ...............................................................
........................
........................
........................
.......................................
5,893
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR CONSULTATION WITH FDA AND TERMINATION OF NOTIFICATION 1
Number of
respondents
Respondent description
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Manufacturers and Repackagers .........................
Wholesale Distributors .........................................
Dispensers ...........................................................
120
22
8
1
1
1
120
22
8
1 ....................................
1 ....................................
1 ....................................
120
22
8
Total ..............................................................
........................
........................
........................
.......................................
150
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN FOR NOTIFICATIONS TO TRADING PARTNERS OF AN
ILLEGITIMATE PRODUCT TERMINATION 1
Number of
respondents
Respondent description
Number of
disclosures
per
respondent
Average
burden per
disclosure
Total annual
disclosures
Total hours
Manufacturers and Repackagers .........................
Wholesale Distributors ..........................................
Dispensers ............................................................
120
22
8
30
1,175
2
3,600
25,850
16
0.2 (12 minutes) ...........
0.2 (12 minutes) ...........
0.2 (12 minutes) ...........
720
5,170
3
Total ...............................................................
........................
........................
........................
.......................................
5,893
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
17:36 Dec 03, 2018
Jkt 247001
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
E:\FR\FM\04DEN1.SGM
04DEN1
Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices
Cumulatively, the total estimated
burden is 12,086 annual hours, which
reflects a significant decrease. We base
this adjustment on our experience with
the information collection since its
establishment and implementation.
Dated: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26295 Filed 12–3–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–5928]
Post-Complete Response Letter
Meetings Between the Food and Drug
Administration and Abbreviated New
Drug Application Applicants Under
Generic Drug User Fee Amendments;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘PostComplete Response Letter Meetings
Between FDA and ANDA Applicants
Under GDUFA.’’ This guidance is
intended to clarify the criteria for
granting post-complete response letter
(CRL) meeting requests and the scope of
discussions for granted meeting
requests. This guidance provides
procedures that will promote wellmanaged post-CRL meetings and help
ensure that such meetings are scheduled
and conducted in accordance with the
commitments made by FDA in
connection with the reauthorization of
the Generic Drug User Fee Amendments
for Fiscal Years 2018–2022 (GDUFA II).
DATES: The announcement of the
guidance is published in the Federal
Register on December 4, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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
VerDate Sep<11>2014
17:36 Dec 03, 2018
Jkt 247001
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–
2017–D–5928 for ‘‘Post-Complete
Response Letter Meetings Between FDA
and ANDA Applicants Under GDUFA.’’
Received comments 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
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
62589
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Lisa
Bercu, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
240–402–6902.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘PostComplete Response Letter Meetings
Between FDA and ANDA Applicants
Under GDUFA.’’ GDUFA was
reauthorized (GDUFA II) on August 18,
2017, in order to facilitate timely access
to high quality, affordable generic
medicines. In accordance with the
GDUFA Reauthorization Performance
Goals and Program Enhancements Fiscal
Years 2018–2022 (GDUFA II Goals or
Commitment Letter) that accompanied
the legislation, FDA committed to
schedule and conduct 90 percent of
post-CRL meetings within prescribed
time frames.
E:\FR\FM\04DEN1.SGM
04DEN1
]]>Agencies
[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Notices]
[Pages 62585-62589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26295]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0609]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Drug Supply Chain
Security Act Implementation: Identification of Suspect Product and
Notification
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of
[[Page 62586]]
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 January
3, 2019.
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 0910-0806.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Guidance for Industry: Drug Supply Chain Security Act Implementation:
Identification of Suspect Product and Notification
OMB Control Number 0910-0806--Extension
This information collection supports the previously captioned
Agency guidance and associated Form FDA 3911. The Drug Supply Chain
Security Act (DSCSA) (Title II of Pub. L. 113-54) added new section
582(h)(2) to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360eee-1(h)(2)), requiring FDA to issue guidance to aid trading
partners in identifying a suspect product and terminating a
notification regarding an illegitimate product and, for a manufacturer,
a product with a high risk of illegitimacy. Suspect product is defined
in section 581(21) of the FD&C Act (21 U.S.C. 360eee(21)), as a product
for which there is reason to believe it: (1) Is potentially
counterfeit, diverted, or stolen; (2) is potentially intentionally
adulterated such that the product would result in serious adverse
health consequences or death to humans; (3) is potentially the subject
of a fraudulent transaction; or (4) appears otherwise unfit for
distribution such that the product would result in serious adverse
health consequences or death to humans.
Beginning January 1, 2015, section 582 of the FD&C Act requires
certain trading partners, upon determining that a product in their
possession or control is a suspect product, to quarantine the product
while they promptly conduct an investigation to determine whether the
product is an illegitimate product. Illegitimate product is defined in
section 581(8) of the FD&C Act as a product for which credible evidence
shows that it: (1) Is counterfeit, diverted, or stolen; (2) is
intentionally adulterated such that the product would result in serious
adverse health consequences or death to humans; (3) is the subject of a
fraudulent transaction; or (4) appears otherwise unfit for distribution
such that the product would be reasonably likely to result in serious
adverse health consequences or death to humans. Also beginning January
1, 2015, trading partners must, upon determining that a product in
their possession or control is illegitimate, notify FDA and all
immediate trading partners that they have reason to believe they may
have received the illegitimate product not later than 24 hours after
making the determination. Under section 582(b)(4)(B)(ii)(II) of the
FD&C Act, manufacturers are additionally required to notify FDA and any
immediate trading partners that they believe may possess a product
manufactured by or purportedly manufactured by the manufacturer not
later than 24 hours after the determination is made or being notified
by FDA or a trading partner that the product has a high risk of
illegitimacy.
Under section 202 of the DSCSA, manufacturers, repackagers,
wholesale distributors, and dispensers (e.g., pharmacies) must: (1)
Notify FDA when they have determined that a product in their possession
or control is illegitimate (and, for manufacturers, when they have
determined or been notified by FDA or a trading partner that a product
has a high risk of illegitimacy); (2) notify certain immediate trading
partners about an illegitimate product that they may have received
(and, for manufacturers, that a product has a high risk of
illegitimacy); (3) terminate notifications regarding illegitimate
products (and, for manufacturers, a product with a high risk of
illegitimacy), in consultation with FDA, when the notifications are no
longer necessary; and (4) notify immediate trading partners when the
notifications are terminated. Trading partners should use Form FDA 3911
to submit notifications and requests for terminations of notifications
to FDA. Form FDA 3911 is available on FDA's web page (https://www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfm).
A. Notifications to FDA
Under section 582(b)(4)(B)(ii)(I), (c)(4)(B)(ii), (d)(4)(B)(ii),
and (e)(4)(B)(ii) of the FD&C Act, as amended by the DSCSA, and
beginning not later than January 1, 2015, a manufacturer, repackager,
wholesale distributor, or dispenser who determines that a product in
its possession or control is illegitimate must notify FDA of that
determination not later than 24 hours after the determination is made.
In addition, section 582(b)(4)(B)(ii)(II) of the FD&C Act requires
manufacturers to notify FDA when a manufacturer determines that a
product poses a high risk of illegitimacy.
We originally estimated that all manufacturers, repackagers,
wholesale distributors, and dispensers would collectively submit 5,000
notifications per year. This estimate included the notifications by
trading partners that have determined that illegitimate product is in
their possession or control, as well as notifications by manufacturers
that have determined a product poses a high risk of illegitimacy. As
discussed in our Federal Register notice of June 11, 2014 (79 FR
33564), the estimate was based on our experience with field alert
reports (Form FDA 3331) that holders of approved drug applications are
required to submit for certain drug quality issues (21 CFR
314.81(b)(1)) and with reports of the falsification of drug sample
records, diversion, loss, and known theft of prescription drug samples
as currently required under Sec. 203.37 (21 CFR 203.37). Upon
evaluation of the number of notifications we received for fiscal years
2016 and 2017, however, we are lowering our estimate to 150
notifications.
We are also combining the estimates for manufacturers and
repackagers because FDA's establishment and drug product listing
database indicates that many companies perform activities of both
manufacturers and repackagers. Although the DSCSA specifically defines
dispensers, for estimation purposes, we are using estimates for
pharmacies in general terms based on those that must comply with the
new requirements under section 582(d) of the FD&C Act.
Because manufacturers, repackagers, and wholesale distributors are
collectively responsible for prescription drugs from the point of
manufacturing through distribution in the drug supply chain, we assume
that most notifications of illegitimate products are
[[Page 62587]]
submitted by these three trading partners. The total number of
respondents is comprised of 80 percent manufacturers (120), 15 percent
wholesale distributors (22), and 5 percent pharmacies (8).
We estimate that the number of annual notifications will vary from
0 to 2 for manufacturers/repackagers, as well as from pharmacies, with
the vast majority of companies making no notifications. Although FDA's
establishment and drug product listing database currently contains
registrations for approximately 6,500 manufacturers and repackagers, we
estimate that approximately 120 manufacturers/repackagers will notify
us of illegitimate products an average of one time per year. Although
we estimate approximately 69,000 pharmacy sites in the United States,
based on data from the National Association of Chain Drug Stores, the
National Community Pharmacists Association, and the American Hospital
Association, we estimate that approximately 8 pharmacies will notify
FDA of illegitimate product an average of one time per year. According
to the Healthcare Distribution Alliance (formerly known as Healthcare
Distribution Management Association), approximately 30 wholesale
distributors are responsible for over 90 percent of drug distributions;
based on sales and because FDA is estimating that over 2,200 small
wholesale distributors might be responsible for the remaining 10
percent of drug sales, we estimate that wholesale distributors will be
responsible for making about an average of 1 notification per year to
account for the estimated 22 notifications that FDA will receive
regarding illegitimate product. Each notification should include
information about the person or entity initiating the notification, the
product determined to be illegitimate or having a high risk of
illegitimacy, and a description of the circumstances surrounding the
event that prompted the notification. We estimate that each
notification will take about 1 hour, as reflected in table 1.
B. Notifications to Trading Partners of an Illegitimate Product or
Product With a High Risk of Illegitimacy
Under section 582(b)(4)(B)(ii)(I), (c)(4)(B)(ii), (d)(4)(B)(ii),
and (e)(4)(B)(ii) of the FD&C Act, a trading partner who determines
that a product in its possession is illegitimate must also notify all
immediate trading partners that they believe may have received such
illegitimate product not later than 24 hours after the determination is
made. In addition, under section 582(b)(4)(B)(ii)(II) of the FD&C Act,
a manufacturer is required to notify all immediate trading partners
that the manufacturer believes may possess a product manufactured by or
purported to be manufactured by the manufacturer not later than 24
hours after the determination is made or being notified by FDA or a
trading partner that the product has a high risk of illegitimacy.
Because the extent of distribution of any illegitimate product is
likely to vary from one situation to another, we assume a wide
distribution of each illegitimate product. We estimate that, for each
notification made by a manufacturer or repackager to FDA, approximately
30 trading partners (based on the number of distributors) will also be
notified. This results in approximately 3,600 notifications annually to
trading partners of manufacturers/repackagers. This estimate includes
the notifications by manufacturers and repackagers who have determined
that illegitimate product is in their possession or control, as well as
notifications by manufacturers that have determined that a product
poses a high risk of illegitimacy.
We estimate that a large wholesale distributor may have up to 4,500
trading partners, but a small wholesale distributor may have 200
trading partners, for an average of approximately 2,350. We originally
estimated that a wholesale distributor would notify all 2,350 trading
partners for each of the illegitimate products identified. However, we
are lowering our estimate as a result of our experience with the
collection and informal feedback from industry to reflect that 22
respondents will make 1,175 disclosures for a total of 25,850
disclosures annually; and that each disclosure will require
approximately 12 minutes, for a total of 5,170 hours annually.
We estimate that a pharmacy purchases prescription drugs from an
average of two wholesale distributors. Therefore, a pharmacy would
notify 2 trading partners for each of the 8 illegitimate products
identified, resulting in approximately 16 notifications annually to
pharmacy trading partners.
Manufacturers/repackagers, wholesale distributors, and pharmacies
may notify their trading partners using existing systems and processes
used for similar types of communications. Such communications may
include, but are not limited to, posting notifications on a company
website, sending an email, telephoning, or mailing or faxing a letter
or notification. The information contained in the notification to the
immediate trading partner should be the same as or based on the
notification that was already submitted to FDA. We estimate that, for
all trading partners, each notification of immediate trading partners
will take approximately 0.2 hour (12 minutes). The estimated total
burden hours that manufacturers/repackagers, wholesale distributors,
and pharmacies will take to notify trading partners is approximately
5,893 hours annually, as reflected in table 2.
C. Consultations With FDA and Termination of Notification
Section 582(b)(4)(B)(iv), (c)(4)(B)(iv), (d)(4)(B)(iv), and
(e)(4)(B)(iv) of the FD&C Act requires that a trading partner who
determines, in consultation with FDA, that a notification made under
section 582(b)(4)(B)(ii), (c)(4)(B)(ii), (d)(4)(B)(ii), or
(e)(4)(B)(ii) is no longer necessary must terminate the notification.
The guidance for industry sets forth the process by which trading
partners should consult with FDA to terminate notifications that are no
longer necessary.
Each request for termination of notification must include
information about the person or entity initiating the request for
termination, the illegitimate product or product with a high risk of
illegitimacy, the notification that was issued, and an explanation
about what actions have taken place or what information has become
available that make the notification no longer necessary. Trading
partners should also include the FDA-assigned incident number
associated with the initial notification on the request for
termination. The request for a termination will be viewed as a request
for consultation with FDA. We estimate that the same amount of time
will be required to provide the information necessary to request
termination as is required to make the notification. The time required
to investigate and resolve an illegitimate product notification will
vary, but we assume that each notification will eventually be
terminated. We assume that the number of requests for termination of a
notification per year will be the same as the original number of
notifications for a given year. The estimated total burden hours of
making requests for termination of notifications to FDA is 150 hours
annually, as reflected in table 3.
D. Notifications to Trading Partners That a Notification Has Been
Terminated
Section 582(b)(4)(B)(iv), (c)(4)(B)(iv), (d)(4)(B)(iv), and
(e)(4)(B)(iv) of the
[[Page 62588]]
FD&C Act requires that a trading partner who, in consultation with FDA,
terminates a notification made under section 582(b)(4)(B)(ii)(I) or
(II), (c)(4)(B)(ii), (d)(4)(B)(ii), or (e)(4)(B)(ii) must also promptly
inform previously-notified immediate trading partners that the
notification has been terminated. We estimate that the burden for
notifying trading partners of an illegitimate product and the number of
trading partners notified will be the same as the estimates for
notification of termination. The estimated total burden hours of
notifying trading partners that the notification is terminated is
approximately 5,893 hours annually, as reflected in table 4.
In the Federal Register of September 6, 2018 (83 FR 45254), 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--Notifications to FDA \1\
----------------------------------------------------------------------------------------------------------------
Number of
Respondent description Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers. 120 1 120 1............... 120
Wholesale Distributors........ 22 1 22 1............... 22
Dispensers.................... 8 1 8 1............... 8
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 150
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Third-Party Disclosure Burden for Notifications to Trading Partners of an Illegitimate
Product \1\
----------------------------------------------------------------------------------------------------------------
Number of
Respondent description Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers. 120 30 3,600 0.20 (12 720
minutes).
Wholesale Distributors........ 22 1,175 25,850 0.20 (12 5,170
minutes).
Dispensers.................... 8 2 16 0.20 (12 3
minutes).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 5,893
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Reporting Burden for Consultation With FDA and Termination of Notification \1\
----------------------------------------------------------------------------------------------------------------
Number of
Respondent description Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers. 120 1 120 1............... 120
Wholesale Distributors........ 22 1 22 1............... 22
Dispensers.................... 8 1 8 1............... 8
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 150
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 4--Estimated Annual Third-Party Disclosure Burden for Notifications to Trading Partners of an Illegitimate
Product Termination \1\
----------------------------------------------------------------------------------------------------------------
Number of
Respondent description Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers. 120 30 3,600 0.2 (12 minutes) 720
Wholesale Distributors........ 22 1,175 25,850 0.2 (12 minutes) 5,170
Dispensers.................... 8 2 16 0.2 (12 minutes) 3
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 5,893
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 62589]]
Cumulatively, the total estimated burden is 12,086 annual hours,
which reflects a significant decrease. We base this adjustment on our
experience with the information collection since its establishment and
implementation.
Dated: November 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26295 Filed 12-3-18; 8:45 am]
BILLING CODE 4164-01-P
