Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification, 45254-45258 [2018-19351]
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Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices
The
Agency is requesting nominations for
nonvoting industry representatives to
the panels listed in the table in this
document.
SUPPLEMENTARY INFORMATION:
I. Medical Devices Advisory Committee
The Committee reviews and evaluates
data on the safety and effectiveness of
marketed and investigational devices
and makes recommendations for their
regulation. The panels engage in a
number of activities to fulfill the
functions the Federal Food, Drug, and
Cosmetic Act (FD&C Act) envisions for
device advisory panels. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
according to its specialty area, advises
the Commissioner of Food and Drugs
(the Commissioner) regarding
recommended classification or
reclassification of devices into one of
three regulatory categories; advises on
any possible risks to health associated
with the use of devices; advises on
formulation of product development
protocols; reviews premarket approval
applications for medical devices;
reviews guidelines and guidance
documents; recommends exemption of
certain devices from the application of
portions of the FD&C Act; advises on the
necessity to ban a device; and responds
to requests from the Agency to review
Dental Products Panel (two representatives—one to represent the
medical device industry, and one to represent the dental drug industry).
Immunology Devices Panel ......................................................................
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II. Qualifications
Persons nominated for the device
panels should be full-time employees of
firms that manufacture products that
would come before the panel, or
consulting firms that represent
manufacturers, or have similar
appropriate ties to industry.
III. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for a particular device panel.
The interested organizations are not
bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner will select the
nonvoting member to represent industry
interests.
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Reviews and evaluates data concerning the safety and effectiveness of
marketed and investigational products for use in dentistry,
endodontics, or bone physiology relative to the oral and maxillofacial
area and makes appropriate recommendations to the Commissioner
of Food and Drugs.
Reviews and evaluates data concerning the safety and effectiveness of
marketed and investigational in vitro devices for use in clinical laboratory medicine including oncology, immunology, and allergy and
makes appropriate recommendations to the Commissioner of Food
and Drugs.
IV. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Nomination
must include a current, complete
re´sume´ or curriculum vitae for each
nominee including current business
address and telephone number, email
address if available, and a signed copy
of the Acknowledgement and Consent
form available at the FDA Advisory
Committee Membership Nomination
Portal (see ADDRESSES) within 30 days of
publication of this document (see
DATES). Nominations must also specify
the advisory panel for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will
forward all nominations to the
organizations expressing interest in
participating in the selection process for
the particular device panels listed in the
table. (Persons who nominate
themselves as nonvoting industry
representatives will not participate in
the selection process).
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
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and make recommendations on specific
issues or problems concerning the safety
and effectiveness of devices. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
according to its specialty area, may also
make appropriate recommendations to
the Commissioner on issues relating to
the design of clinical studies regarding
the safety and effectiveness of marketed
and investigational devices. The
Committee also provides
recommendations to the Commissioner
or designee on complexity
categorization of in vitro diagnostics
under the Clinical Laboratory
Improvement Amendments of 1988.
Sfmt 4703
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: August 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19350 Filed 9–5–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0609]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry: 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 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
SUMMARY:
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to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the identification
of a suspect product and the termination
of notifications regarding an illegitimate
product.
DATES: Submit either electronic or
written comments on the collection of
information by November 5, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before November 5,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 5, 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’’).
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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
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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–
2014–D–0609 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Guidance
for Industry: Drug Supply Chain
Security Act Implementation:
Identification of Suspect Product and
Notification.’’ 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/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.
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45255
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
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.
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), requiring FDA to issue
guidance to aid trading partners in
identifying a suspect product and
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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 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
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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 (FARs) (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
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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
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
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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
hours (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
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.
FDA estimates the burden of this
collection of information as follows:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—NOTIFICATIONS TO FDA 1
Number of
respondents
Respondent description
Manufacturers and Repackagers .........................................
Wholesale Distributors .........................................................
Dispensers ...........................................................................
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Number of
responses per
respondent
120
22
8
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Total annual
responses
1
1
1
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120
22
8
06SEN1
Average
burden per
response
Total hours
1
1
1
120
22
8
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—NOTIFICATIONS TO FDA 1—Continued
Respondent description
Total ..............................................................................
1 There
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
........................
........................
........................
........................
Total hours
150
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
3.2
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
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
3.2
Total ...............................................................
........................
........................
........................
.......................................
5,893
1 There
daltland on DSKBBV9HB2PROD with NOTICES
Number of
disclosures
per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Request for Nominations of Voting
Members on a Public Advisory
Committee; National Mammography
Quality Assurance Advisory
Committee
[FR Doc. 2018–19351 Filed 9–5–18; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2018–N–3207]
BILLING CODE 4164–01–P
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting
SUMMARY:
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16:56 Sep 05, 2018
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nominations for voting members to
serve on the National Mammography
Quality Assurance Advisory Committee
in the Center for Devices and
Radiological Health. Nominations will
be accepted for upcoming vacancies
effective with this notice.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
DATES: Nominations received on or
before November 5, 2018, will be given
first consideration for membership on
the National Mammography Quality
E:\FR\FM\06SEN1.SGM
06SEN1
]]>Agencies
[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Pages 45254-45258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19351]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0609]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry: 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 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
[[Page 45255]]
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the identification of a suspect product and
the termination of notifications regarding an illegitimate product.
DATES: Submit either electronic or written comments on the collection
of information by November 5, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 5, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 5, 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-2014-D-0609 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Guidance for Industry: Drug
Supply Chain Security Act Implementation: Identification of Suspect
Product and Notification.'' 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.
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),
requiring FDA to issue guidance to aid trading partners in identifying
a suspect product and
[[Page 45256]]
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 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 (FARs) (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 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
[[Page 45257]]
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 hours (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 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.
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
-------------------------------------------------------------------------------
[[Page 45258]]
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 3.2
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) 3.2
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 5,893
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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: August 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19351 Filed 9-5-18; 8:45 am]
BILLING CODE 4164-01-P
