Agency Information Collection Activities; Proposed Collection; Comment Request; Drug Supply Chain Security Act Implementation, 49538-49542 [2021-19061]
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respect to establishing a mammography
facilities certification program. The
Committee shall advise the HHS
Secretary and the Commissioner or
designee on:
(A) Developing appropriate quality
standards and regulations for
mammography facilities;
(B) Developing appropriate standards
and regulations for bodies accrediting
mammography facilities under this
program;
(C) Developing regulations with
respect to sanctions;
(D) Developing procedures for
monitoring compliance with standards;
(E) Establishing a mechanism to
investigate consumer complaints;
(F) Reporting new developments
concerning breast imaging which should
be considered in the oversight of
mammography facilities;
(G) Determining whether there exists
a shortage of mammography facilities in
rural and health professional shortage
areas and determining the effects of
personnel on access to the services of
such facilities in such areas;
(H) Determining whether there will
exist a sufficient number of medical
physicists after October 1, 1999; and
(I) Determining the costs and benefits
of compliance with these requirements.
The Committee shall consist of a core
of 15 members, including the Chair.
Members and the Chair are selected by
the Commissioner or designee from
among physicians, practitioners, and
other health professionals, whose
clinical practice, research
specialization, or professional expertise
includes a significant focus on
mammography. Members will be invited
to serve for overlapping terms of up to
4 years. Almost all members of this
committee serve as Special Government
Employees. The core of voting members
shall include at least four individuals
from among national breast cancer or
consumer health organizations with
expertise in mammography, and at least
two practicing physicians who provide
mammography services. In addition to
the voting members, the Committee
shall include two nonvoting industry
representative members who have
expertise in mammography equipment.
The Committee may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/RadiationEmittingProducts/
NationalMammography
QualityAssuranceAdvisoryCommittee/
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ucm520365.htm or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–19108 Filed 9–2–21; 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; Drug Supply Chain
Security Act Implementation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection associated with the Federal
Food, Drug, and Cosmetic Act (FD&C
Act).
DATES: Submit either electronic or
written comments on the collection of
information by November 2, 2021.
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 2,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 2, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
SUMMARY:
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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; Drug
Supply Chain Security Act
Implementation.’’ 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, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
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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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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. 3501–3521), 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
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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.
Drug Supply Chain Security Act
Implementation
OMB Control Number 0910–0806—
Revision
This information collection helps to
support implementation of section 582
of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360eee–1).
Enacted in 2013, the Drug Supply Chain
Security Act (DSCSA) (Title II of Pub. L.
113–54) amended section 582 of the
FD&C Act and outlines steps to build an
electronic, interoperable system to
identify and trace certain prescription
drugs as they are distributed in the
United States. The DSCSA is intended
to enhance FDA’s ability to help protect
consumers from exposure to drugs that
may be counterfeit, stolen,
contaminated, or otherwise harmful.
Respondents to the information
collection are manufacturers,
wholesalers, dispensers, and
repackagers, as defined in section 581 of
the FD&C Act (21 U.S.C. 360eee), of
pharmaceutical drug products.
To assist respondents with statutory
requirements set forth in section 582
pertaining to notifications of illegitimate
products or products with a high risk of
illegitimacy, we developed Form FDA
3911 entitled ‘‘Drug Notification’’ along
with the corresponding instructional
document ‘‘INSTRUCTIONS FOR
COMPLETION OF FORM FDA 3911—
DRUG NOTIFICATION.’’ Form FDA
3911 and the instructions are available
from, and may be completed using, our
website at https://www.fda.gov/drugs/
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49539
drug-supply-chain-security-act-dscsa/
drug-notifications-frequently-askedquestions. Form FDA 3911 is intended
to facilitate notifications governed by
section 582 by providing a uniform
format for initial notifications, followup
notifications, and requests for the
termination of a notification.
Section 582 of the FD&C Act also
provides for FDA issuance of guidance
documents to facilitate implementation
of the DSCSA. To that end, we continue
to develop guidance documents to assist
respondents with information collection
provisions set forth in section 582. The
procedural guidance document entitled
‘‘Drug Supply Chain Security Act
Implementation: Identification of
Suspect Product and Notification’’ (June
2021; available at: https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/drug-supplychain-security-act-implementationidentification-suspect-product-andnotification) is intended to assist
respondents in identifying suspect
products, as defined at section 581, and
with terminating notifications of
illegitimate product or products with a
high risk of illegitimacy. As explained
in the guidance document, beginning
January 1, 2015, certain trading partners
(i.e., manufacturers, repackagers,
wholesale distributors, or dispensers),
upon determining that a product in their
possession or control is a suspect
product, must quarantine the product
while they promptly conduct an
investigation to determine whether the
product is an illegitimate product, must
notify FDA if they determine that the
product is illegitimate product, and
must notify certain trading partners of
the illegitimate product as prescribed by
section 582. Manufacturers must also
notify FDA and certain immediate
trading partners after determining that a
product in their possession or control
has a high risk of being illegitimate
product.
Similarly, we developed the draft
guidance document ‘‘Waivers,
Exceptions, and Exemptions From the
Requirements of Section 582 of the
Federal Food, Drug, and Cosmetic Act’’
(May 2018; available at: https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
waivers-exceptions-and-exemptionsrequirements-section-582-federal-fooddrug-and-cosmetic-act). The draft
guidance explains Agency established
processes by which: (1) A trading
partner may request a waiver from
certain requirements in section 582 if it
would result in an undue economic
hardship or for emergency medical
reasons; (2) a manufacturer or
repackager may request an exception to
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the section 582 requirements related to
product identifiers if a product is
packaged in a container too small or
otherwise unable to accommodate a
label with sufficient space to bear the
required information; and (3) FDA may
determine other products or
transactions that shall be exempt from
requirements of section 582.
FDA has recently published the draft
guidance document ‘‘Enhanced Drug
Distribution Security at the Package
Level Under the Drug Supply Chain
Security Act’’ (June 2021; available at:
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/enhanced-drug-distributionsecurity-package-level-under-drugsupply-chain-security-act). The draft
guidance clarifies the enhanced system
requirements listed in section 582(g)(1)
of the FD&C Act. This draft guidance
also outlines and provides
recommendations on the system
attributes necessary for enabling the
secure tracing of product at the package
level, including allowing for the use of
verification, inference, and aggregation,
as necessary. FDA has also published a
draft guidance document entitled
‘‘DSCSA Standards for the Interoperable
Exchange of Information for Tracing of
Certain Human, Finished, Prescription
Drugs: How to Exchange Product
Tracing Information’’ (November 2014;
available at: https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/dscsa-standardsinteroperable-exchange-informationtracing-certain-human-finishedprescription-drugs). This draft guidance
establishes initial standards for the
interoperable exchange of product
tracing information, in paper or
electronic format, for compliance with
sections 582(a) through (e) of the FD&C
Act.
Two additional guidance documents
help to further explain the statutory
requirements of section 582. The
‘‘Product Identifiers under the Drug
Supply Chain Security Act—Questions
and Answers’’ guidance for industry
(June 2021; available at: https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
product-identifiers-under-drug-supplychain-security-act-questions-andanswers) is intended to address
anticipated questions regarding product
identifiers that are required under
section 582 for packages and
homogenous cases of certain drug
products. The ‘‘Verification Systems
Under the Drug Supply Chain Security
Act for Certain Prescription Drugs’’ draft
guidance (October 2018; available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/verification-systems-under-
drug-supply-chain-security-act-certainprescription-drugs) provides
recommendations for a robust
verification system for the
determination, quarantine, and
investigation of suspect products, as
well as the quarantine, notification, and
disposition of illegitimate products. The
guidance also addresses FDA’s
recommendation that trading partners
submit cleared product notifications.
Finally, the guidance addresses the
statutory requirements for verification,
including verification of saleable
returns, at the package level for product
identifiers on packages and homogenous
cases intended to be introduced in a
transaction into commerce.
FDA guidance documents are issued
consistent with requirements found in
section 582, as well as our Good
Guidance Practice regulations found in
21 CFR 10.115, which provide for
public comment at any time. In
addition, since enactment of the
DSCSA, our Center for Drug Evaluation
and Research has developed and
continues to maintain a website
communicating DSCSA implementation
activity, including relevant resources at:
https://www.fda.gov/drugs/drug-supplychain-integrity/drug-supply-chainsecurity-act-dscsa.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—NOTIFICATIONS TO FDA 1
Number of
respondents
Type of respondent
Number of
responses per
respondent
Total
annual
responses
Average
time per
response
Total hours
Manufacturers and Repackagers .........................................
Wholesale Distributors .........................................................
Dispenser .............................................................................
100
138
12
1
1
1
100
138
12
1
1
1
100
138
12
Total ..............................................................................
........................
........................
250
........................
250
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
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Type of respondent
Number of
disclosures
per
respondent
Total
disclosures
Average
time per
disclosure
Total hours
Manufacturers and Repackagers .........................................
Wholesale Distributors .........................................................
Dispensers ...........................................................................
100
138
12
30
1,175
2
3,000
162,150
24
* 0.20
* 0.20
* 0.20
600
32,430
5
Total ..............................................................................
........................
........................
165,174
........................
33,035
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
* (12 minutes.)
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TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR CONSULTATION WITH FDA AND TERMINATION OF NOTIFICATION 1
Number of
responses per
respondent
Number of
respondents
Type of respondent
Total
annual
responses
Average
time per
response
Total hours
Manufacturers and Repackagers .........................................
Wholesale Distributors .........................................................
Dispensers ...........................................................................
100
138
12
1
1
1
100
138
12
1
1
1
100
138
12
Total ..............................................................................
........................
........................
250
........................
250
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
disclosures
per
respondent
Number of
respondents
Type of respondent
Average
time per
disclosure
Total
disclosures
Total hours
Manufacturers and Repackagers .........................................
Wholesale Distributors .........................................................
Dispensers ...........................................................................
100
138
12
30
1,175
2
3,000
162,150
24
* 0.20
* 0.20
* 0.20
600
32,430
5
Total ..............................................................................
........................
........................
165,174
........................
33,035
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
* (12 minutes.)
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR REQUESTS FOR WAIVERS, EXCEPTIONS, OR EXEMPTIONS 1
Total
annual
responses
Average
time per
response
Total hours
Requests to FDA for a Waiver, Exception, or Exemption ...
Notifications to FDA of a Material Change in Circumstances Warranting the Waiver, Exception, or Exemption .............................................................................
Requests to FDA to Renew a Waiver, Exception, or Exemption .............................................................................
20
1
20
80
1,600
1
1
1
16
16
1
1
1
16
16
Total ..............................................................................
........................
........................
22
........................
1,632
1 There
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Number of
responses per
respondent
Number of
respondents
Type of respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on illegitimate product
notifications already received, we
estimate a total of 250 respondents to
the information collection. Our database
for establishment and drug product
listing suggests that many companies
perform activities of both manufacturers
and repackagers and therefore we have
combined our estimated number of
respondent manufacturers and
repackagers. In addition, because
statutory provisions specifically define
‘‘dispensers’’ to include retail
pharmacies, hospital pharmacies, and
groups of chain pharmacies, our
estimate of the number of dispensers is
intended to reflect the overall estimated
number of respondents we believe to be
subject to the 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,
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we assume that these three trading
partners submit most notifications of
illegitimate products. Upon evaluation
of those notifications received in fiscal
year (FY) 2020 and, thus far, in FY 2021,
we assume those 250 respondents are
comprised of 40 percent manufacturers
(100), 55 percent wholesale distributors
(138), and 5 percent pharmacies (12).
We assume that annual notifications
will vary from zero to two for
manufacturers and repackagers, as well
as from pharmacies, but that most of
companies will make no notifications.
Although our establishment and drug
product listing database currently
reflects approximately 1,400
manufacturers and repackagers, we
estimate only 100 manufacturers and
repackagers will notify us of illegitimate
products an average of one time per
year.
Relying on data from the National
Association of Chain Drug Stores, the
National Community Pharmacists
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Association, and the American Hospital
Association, we assume there are
approximately 67,000 pharmacy sites in
the United States. Based on a review of
data, we estimate 12 pharmacies will
notify FDA of illegitimate product an
average of 1 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 1,570 small
wholesale distributors may be
responsible for the remaining 10 percent
of drug sales, we estimate that
wholesale distributors will be
responsible for making approximately
an average of 1 notification per year to
account for the estimated 138
notifications that FDA will receive
regarding illegitimate product. We
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assume wholesale distributors will
expend 1 hour for each notification.
Because the extent of distribution of
any illegitimate product will vary, we
assume a wide distribution for each
illegitimate product for purposes of
establishing our burden estimate. We
estimate that, for each notification that
a manufacturer or repackager makes to
FDA, the manufacturer or repackager
will notify approximately 30 trading
partners (relying on the number of
distributors). This formula results in
approximately 3,000 notifications
annually to trading partners of
manufacturers and repackagers. This
estimate includes the notifications by
manufacturers and repackagers who
have determined that an illegitimate
product is in their possession or control,
as well as notifications by
manufacturers who have determined
that a product poses a high risk of
illegitimacy.
We assume that a large wholesale
distributor may have up to 4,500 trading
partners, where a small wholesale
distributor may have 200 trading
partners, averaging approximately
2,350. We had originally estimated that
a wholesale distributor would notify all
2,350 trading partners for each of the
illegitimate products identified.
However, as a result of our experience
with the collection and informal
feedback from industry, we have
lowered our estimate to reflect that 138
respondents will make 1,175 disclosures
for a total of 162,150 disclosures
annually and that each disclosure will
require approximately 12 minutes, for a
total of 32,430 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 12
illegitimate products identified. This
estimate results in in approximately 24
notifications annually to pharmacy
trading partners.
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 to notify trading partners that the
notification is terminated is
approximately 33,035 hours annually.
We assume a comparable amount of
time is required to provide the
information necessary for requesting to
terminate a 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
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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 to make requests for termination
of notifications to FDA is 250 hours
annually.
Based on communications we have
had with trading partners and
stakeholders since the 2013 enactment
of the DSCSA, we estimate that 20
trading partners or stakeholders will
submit approximately 20 requests for a
waiver, an exception, or an exemption.
Also based on feedback from industry
stakeholders, we estimate that
respondents will expend an average of
80 hours to prepare and submit each
request and to submit any additional
followup information that we may
request. We estimate the total burden as
approximately 1,600 hours.
We estimate that we will receive from
approximately one respondent
approximately one notification or other
information informing us that there has
or has not been a material change in the
circumstances that warranted the
waiver, exception, or exemption and
that each notification will require
approximately 16 hours to prepare and
submit to us. We estimate the total
burden as approximately 16 hours.
We estimate that we will receive
approximately one renewal request from
approximately one respondent and that
each request will require approximately
16 hours to prepare and submit to us.
We estimate the total burden as
approximately 16 hours.
Our estimated burden for the
information collection reflects an
overall increase of 56,116 hours and a
corresponding increase of 271,638
responses annually. We attribute this
adjustment to an increase in the number
of illegitimate product notification
submissions we received in the last
couple of years and the number of such
submissions we have received so far this
fiscal year.
Dated: August 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–19061 Filed 9–2–21; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2012–N–0536]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
User Fee Cover Sheet, Form FDA 3601
and Device Facility User Fee Cover
Sheet, Form FDA 3601a
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by October 4,
2021.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0511 Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Medical Device User Fee Cover Sheet,
Form FDA 3601 and Device Facility
User Fee Cover Sheet, Form FDA 3601a
OMB Control Number 0910–0511—
Revision
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Federal Food, Drug, and Cosmetic
Act, as amended by the Medical Device
User Fee and Modernization Act of 2002
(Pub. L. 107–250), and the Medical
Device User Fee Amendments of 2007
(Title II of the Food and Drug
Frm 00039
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]]>Agencies
[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49538-49542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19061]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0609]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Drug Supply Chain Security Act Implementation
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or written comments on the collection
of information by November 2, 2021.
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 2, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 2, 2021. 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; Drug Supply Chain Security Act
Implementation.'' 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, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential
[[Page 49539]]
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.govinfo.gov/content/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, 240-402-7500.
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. 3501-3521), 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.
Drug Supply Chain Security Act Implementation
OMB Control Number 0910-0806--Revision
This information collection helps to support implementation of
section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360eee-1). Enacted in 2013, the Drug Supply Chain Security Act
(DSCSA) (Title II of Pub. L. 113-54) amended section 582 of the FD&C
Act and outlines steps to build an electronic, interoperable system to
identify and trace certain prescription drugs as they are distributed
in the United States. The DSCSA is intended to enhance FDA's ability to
help protect consumers from exposure to drugs that may be counterfeit,
stolen, contaminated, or otherwise harmful. Respondents to the
information collection are manufacturers, wholesalers, dispensers, and
repackagers, as defined in section 581 of the FD&C Act (21 U.S.C.
360eee), of pharmaceutical drug products.
To assist respondents with statutory requirements set forth in
section 582 pertaining to notifications of illegitimate products or
products with a high risk of illegitimacy, we developed Form FDA 3911
entitled ``Drug Notification'' along with the corresponding
instructional document ``INSTRUCTIONS FOR COMPLETION OF FORM FDA 3911--
DRUG NOTIFICATION.'' Form FDA 3911 and the instructions are available
from, and may be completed using, our website at https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-notifications-frequently-asked-questions. Form FDA 3911 is intended to facilitate
notifications governed by section 582 by providing a uniform format for
initial notifications, followup notifications, and requests for the
termination of a notification.
Section 582 of the FD&C Act also provides for FDA issuance of
guidance documents to facilitate implementation of the DSCSA. To that
end, we continue to develop guidance documents to assist respondents
with information collection provisions set forth in section 582. The
procedural guidance document entitled ``Drug Supply Chain Security Act
Implementation: Identification of Suspect Product and Notification''
(June 2021; available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-supply-chain-security-act-implementation-identification-suspect-product-and-notification) is
intended to assist respondents in identifying suspect products, as
defined at section 581, and with terminating notifications of
illegitimate product or products with a high risk of illegitimacy. As
explained in the guidance document, beginning January 1, 2015, certain
trading partners (i.e., manufacturers, repackagers, wholesale
distributors, or dispensers), upon determining that a product in their
possession or control is a suspect product, must quarantine the product
while they promptly conduct an investigation to determine whether the
product is an illegitimate product, must notify FDA if they determine
that the product is illegitimate product, and must notify certain
trading partners of the illegitimate product as prescribed by section
582. Manufacturers must also notify FDA and certain immediate trading
partners after determining that a product in their possession or
control has a high risk of being illegitimate product.
Similarly, we developed the draft guidance document ``Waivers,
Exceptions, and Exemptions From the Requirements of Section 582 of the
Federal Food, Drug, and Cosmetic Act'' (May 2018; available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/waivers-exceptions-and-exemptions-requirements-section-582-federal-food-drug-and-cosmetic-act). The draft guidance explains Agency
established processes by which: (1) A trading partner may request a
waiver from certain requirements in section 582 if it would result in
an undue economic hardship or for emergency medical reasons; (2) a
manufacturer or repackager may request an exception to
[[Page 49540]]
the section 582 requirements related to product identifiers if a
product is packaged in a container too small or otherwise unable to
accommodate a label with sufficient space to bear the required
information; and (3) FDA may determine other products or transactions
that shall be exempt from requirements of section 582.
FDA has recently published the draft guidance document ``Enhanced
Drug Distribution Security at the Package Level Under the Drug Supply
Chain Security Act'' (June 2021; available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security-act). The draft guidance clarifies the enhanced system requirements
listed in section 582(g)(1) of the FD&C Act. This draft guidance also
outlines and provides recommendations on the system attributes
necessary for enabling the secure tracing of product at the package
level, including allowing for the use of verification, inference, and
aggregation, as necessary. FDA has also published a draft guidance
document entitled ``DSCSA Standards for the Interoperable Exchange of
Information for Tracing of Certain Human, Finished, Prescription Drugs:
How to Exchange Product Tracing Information'' (November 2014; available
at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dscsa-standards-interoperable-exchange-information-tracing-certain-human-finished-prescription-drugs). This draft guidance
establishes initial standards for the interoperable exchange of product
tracing information, in paper or electronic format, for compliance with
sections 582(a) through (e) of the FD&C Act.
Two additional guidance documents help to further explain the
statutory requirements of section 582. The ``Product Identifiers under
the Drug Supply Chain Security Act--Questions and Answers'' guidance
for industry (June 2021; available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-identifiers-under-drug-supply-chain-security-act-questions-and-answers) is intended to
address anticipated questions regarding product identifiers that are
required under section 582 for packages and homogenous cases of certain
drug products. The ``Verification Systems Under the Drug Supply Chain
Security Act for Certain Prescription Drugs'' draft guidance (October
2018; available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/verification-systems-under-drug-supply-chain-security-act-certain-prescription-drugs) provides recommendations for a
robust verification system for the determination, quarantine, and
investigation of suspect products, as well as the quarantine,
notification, and disposition of illegitimate products. The guidance
also addresses FDA's recommendation that trading partners submit
cleared product notifications. Finally, the guidance addresses the
statutory requirements for verification, including verification of
saleable returns, at the package level for product identifiers on
packages and homogenous cases intended to be introduced in a
transaction into commerce.
FDA guidance documents are issued consistent with requirements
found in section 582, as well as our Good Guidance Practice regulations
found in 21 CFR 10.115, which provide for public comment at any time.
In addition, since enactment of the DSCSA, our Center for Drug
Evaluation and Research has developed and continues to maintain a
website communicating DSCSA implementation activity, including relevant
resources at: https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden--Notifications to FDA \1\
----------------------------------------------------------------------------------------------------------------
Number of
Type of respondent Number of responses per Total annual Average time Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers... 100 1 100 1 100
Wholesale Distributors.......... 138 1 138 1 138
Dispenser....................... 12 1 12 1 12
-------------------------------------------------------------------------------
Total....................... .............. .............. 250 .............. 250
----------------------------------------------------------------------------------------------------------------
\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
Type of respondent Number of disclosures Total Average time Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers... 100 30 3,000 * 0.20 600
Wholesale Distributors.......... 138 1,175 162,150 * 0.20 32,430
Dispensers...................... 12 2 24 * 0.20 5
-------------------------------------------------------------------------------
Total....................... .............. .............. 165,174 .............. 33,035
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
* (12 minutes.)
[[Page 49541]]
Table 3--Estimated Annual Reporting Burden for Consultation With FDA and Termination of Notification \1\
----------------------------------------------------------------------------------------------------------------
Number of
Type of respondent Number of responses per Total annual Average time Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers... 100 1 100 1 100
Wholesale Distributors.......... 138 1 138 1 138
Dispensers...................... 12 1 12 1 12
-------------------------------------------------------------------------------
Total....................... .............. .............. 250 .............. 250
----------------------------------------------------------------------------------------------------------------
\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
Type of respondent Number of disclosures Total Average time Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Manufacturers and Repackagers... 100 30 3,000 * 0.20 600
Wholesale Distributors.......... 138 1,175 162,150 * 0.20 32,430
Dispensers...................... 12 2 24 * 0.20 5
-------------------------------------------------------------------------------
Total....................... .............. .............. 165,174 .............. 33,035
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
* (12 minutes.)
Table 5--Estimated Annual Reporting Burden for Requests for Waivers, Exceptions, or Exemptions \1\
----------------------------------------------------------------------------------------------------------------
Number of
Type of respondent Number of responses per Total annual Average time Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Requests to FDA for a Waiver, 20 1 20 80 1,600
Exception, or Exemption........
Notifications to FDA of a 1 1 1 16 16
Material Change in
Circumstances Warranting the
Waiver, Exception, or Exemption
Requests to FDA to Renew a 1 1 1 16 16
Waiver, Exception, or Exemption
-------------------------------------------------------------------------------
Total....................... .............. .............. 22 .............. 1,632
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on illegitimate product notifications already received, we
estimate a total of 250 respondents to the information collection. Our
database for establishment and drug product listing suggests that many
companies perform activities of both manufacturers and repackagers and
therefore we have combined our estimated number of respondent
manufacturers and repackagers. In addition, because statutory
provisions specifically define ``dispensers'' to include retail
pharmacies, hospital pharmacies, and groups of chain pharmacies, our
estimate of the number of dispensers is intended to reflect the overall
estimated number of respondents we believe to be subject to the
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 these
three trading partners submit most notifications of illegitimate
products. Upon evaluation of those notifications received in fiscal
year (FY) 2020 and, thus far, in FY 2021, we assume those 250
respondents are comprised of 40 percent manufacturers (100), 55 percent
wholesale distributors (138), and 5 percent pharmacies (12). We assume
that annual notifications will vary from zero to two for manufacturers
and repackagers, as well as from pharmacies, but that most of companies
will make no notifications. Although our establishment and drug product
listing database currently reflects approximately 1,400 manufacturers
and repackagers, we estimate only 100 manufacturers and repackagers
will notify us of illegitimate products an average of one time per
year.
Relying on data from the National Association of Chain Drug Stores,
the National Community Pharmacists Association, and the American
Hospital Association, we assume there are approximately 67,000 pharmacy
sites in the United States. Based on a review of data, we estimate 12
pharmacies will notify FDA of illegitimate product an average of 1 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
1,570 small wholesale distributors may be responsible for the remaining
10 percent of drug sales, we estimate that wholesale distributors will
be responsible for making approximately an average of 1 notification
per year to account for the estimated 138 notifications that FDA will
receive regarding illegitimate product. We
[[Page 49542]]
assume wholesale distributors will expend 1 hour for each notification.
Because the extent of distribution of any illegitimate product will
vary, we assume a wide distribution for each illegitimate product for
purposes of establishing our burden estimate. We estimate that, for
each notification that a manufacturer or repackager makes to FDA, the
manufacturer or repackager will notify approximately 30 trading
partners (relying on the number of distributors). This formula results
in approximately 3,000 notifications annually to trading partners of
manufacturers and repackagers. This estimate includes the notifications
by manufacturers and repackagers who have determined that an
illegitimate product is in their possession or control, as well as
notifications by manufacturers who have determined that a product poses
a high risk of illegitimacy.
We assume that a large wholesale distributor may have up to 4,500
trading partners, where a small wholesale distributor may have 200
trading partners, averaging approximately 2,350. We had originally
estimated that a wholesale distributor would notify all 2,350 trading
partners for each of the illegitimate products identified. However, as
a result of our experience with the collection and informal feedback
from industry, we have lowered our estimate to reflect that 138
respondents will make 1,175 disclosures for a total of 162,150
disclosures annually and that each disclosure will require
approximately 12 minutes, for a total of 32,430 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 12 illegitimate products
identified. This estimate results in in approximately 24 notifications
annually to pharmacy trading partners.
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 to notify trading partners that the
notification is terminated is approximately 33,035 hours annually.
We assume a comparable amount of time is required to provide the
information necessary for requesting to terminate a 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 to make requests for termination of notifications to FDA is 250
hours annually.
Based on communications we have had with trading partners and
stakeholders since the 2013 enactment of the DSCSA, we estimate that 20
trading partners or stakeholders will submit approximately 20 requests
for a waiver, an exception, or an exemption. Also based on feedback
from industry stakeholders, we estimate that respondents will expend an
average of 80 hours to prepare and submit each request and to submit
any additional followup information that we may request. We estimate
the total burden as approximately 1,600 hours.
We estimate that we will receive from approximately one respondent
approximately one notification or other information informing us that
there has or has not been a material change in the circumstances that
warranted the waiver, exception, or exemption and that each
notification will require approximately 16 hours to prepare and submit
to us. We estimate the total burden as approximately 16 hours.
We estimate that we will receive approximately one renewal request
from approximately one respondent and that each request will require
approximately 16 hours to prepare and submit to us. We estimate the
total burden as approximately 16 hours.
Our estimated burden for the information collection reflects an
overall increase of 56,116 hours and a corresponding increase of
271,638 responses annually. We attribute this adjustment to an increase
in the number of illegitimate product notification submissions we
received in the last couple of years and the number of such submissions
we have received so far this fiscal year.
Dated: August 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19061 Filed 9-2-21; 8:45 am]
BILLING CODE 4164-01-P
