Agency Information Collection Activities: Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records, 54385-54388 [2020-19239]
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Federal Register / Vol. 85, No. 170 / Tuesday, September 1, 2020 / Notices
procurement-service-contractinventories. GSA has posted its FY 2016
and FY 2017 inventory analyses and its
planned analyses of FY 2018 and FY
2019 actions at the following location:
https://www.gsa.gov/gsasci.
Jeffrey A. Koses,
Senior Procurement Executive, Office of
Acquisition Policy, Office of Governmentwide Policy.
BILLING CODE 6820–61–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1064]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; State Petitions for
Exemption From Preemption
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
State Petitions for Exemption From
Preemption—21 CFR 100.1(d)
Submit written comments
(including recommendations) on the
collection of information by October 1,
2020.
OMB Control Number 0910–0277—
Extension
DATES:
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 0910–0277. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
[FR Doc. 2020–19297 Filed 8–31–20; 8:45 am]
Notice.
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.
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:
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
54385
Under section 403A(b) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 343–1(b)), States may
petition FDA for exemption from
Federal preemption of State food
labeling and standard-of-identity
requirements. Section 100.1(d) (21 CFR
100.1(d)) sets forth the information a
State is required to submit in such a
petition. The information required
under § 100.1(d) enables FDA to
determine whether the State food
labeling or standard-of-identity
requirement satisfies the criteria of
section 403A(b) of the FD&C Act for
granting exemption from Federal
preemption.
Description of Respondents: The
respondents to this collection of
information are State and local
governments who regulate food labeling
and standards of identity.
In the Federal Register of May 22,
2020 (85 FR 31190), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
100.1(d) ................................................................................
1
1
1
40
40
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for § 100.1(d) is
minimal because petitions for
exemption from preemption are seldom
submitted by States. In the last 3 years,
we have received one new petition for
exemption from preemption; therefore,
we estimate that one or fewer petitions
will be submitted annually.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
AGENCY:
[FR Doc. 2020–19256 Filed 8–31–20; 8:45 am]
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
BILLING CODE 4164–01–Ps
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Food and Drug Administration
[Docket No. FDA–2011–N–0231]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Adverse
Experience Reporting for Licensed
Biological Products; and General
Records
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00043
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Sfmt 4703
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the proposed
extension of the collection of
information concerning requirements
relating to FDA’s Adverse Experience
Reporting System (FAERS) for licensed
biological products, and general records
associated with the manufacture and
distribution of biological products.
Submit either electronic or
written comments on the collection of
information by November 2, 2020.
DATES:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
ADDRESSES:
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Federal Register / Vol. 85, No. 170 / Tuesday, September 1, 2020 / Notices
considered. Electronic comments must
be submitted on or before November 2,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 2, 2020.
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.
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0231 for ‘‘Adverse Experience
Reporting for Licensed Biological
Products; and General Records.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
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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
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–45, 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
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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.
Adverse Experience Reporting For
Licensed Biological Products; and
General Records—21 CFR Part 600
OMB Control Number 0910–0308—
Extension
Under the Public Health Service Act
(42 U.S.C. 262), FDA may only approve
a biologics license application for a
biological product that is safe, pure, and
potent. When a biological product is
approved and enters the market, the
product is introduced to a larger patient
population in settings different from
clinical trials. New information
generated during the postmarketing
period offers further insight into the
benefits and risks of the product, and
evaluation of this information is
important to ensure its safe use. FDA
issued the Adverse Experience
Reporting (AER) requirements in part
600 (21 CFR part 600) to enable FDA to
take actions necessary for the protection
of the public health in response to
reports of adverse experiences related to
licensed biological products. The
primary purpose of FDA’s FAERS is to
identify potentially serious safety
problems with licensed biological
products. Although premarket testing
discloses a general safety profile of a
biological product’s comparatively
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Federal Register / Vol. 85, No. 170 / Tuesday, September 1, 2020 / Notices
common adverse effects, the larger and
more diverse patient populations
exposed to the licensed biological
product provides the opportunity to
collect information on rare, latent, and
long-term effects. In addition,
production and/or distribution
problems have contaminated biological
products in the past. AER reports are
obtained from a variety of sources,
including manufacturers, patients,
physicians, foreign regulatory agencies,
and clinical investigators. Identification
of new and unexpected safety issues
through the analysis of the data in
FAERS contributes directly to increased
public health protection. For example,
evaluation of these safety issues enables
FDA to take focused regulatory action.
Such action may include, but is not
limited to, important changes to the
product’s labeling (such as adding a
new warning), coordination with
manufacturers to ensure adequate
corrective action is taken, and removal
of a biological product from the market
when necessary.
Section 600.80(c)(1) requires licensed
manufacturers or any person whose
name appears on the label of a licensed
biological product to report each
adverse experience that is both serious
and unexpected, whether foreign or
domestic, as soon as possible but in no
case later than 15 calendar days of
initial receipt of the information by the
licensed manufacturer. These reports
are known as postmarketing 15-day
Alert reports. This section also requires
licensed manufacturers to submit any
followup reports within 15 calendar
days of receipt of new information or as
requested by FDA, and if additional
information is not obtainable, to
maintain records of the unsuccessful
steps taken to seek additional
information. In addition, this section
requires that a person who submits an
adverse action report to the licensed
manufacturer, rather than to FDA,
maintain a record of this action. Section
600.80(e) requires licensed
manufacturers to submit a 15-day Alert
report for an adverse experience
obtained from a postmarketing clinical
study only if the licensed manufacturer
concludes that there is a reasonable
possibility that the product caused the
adverse experience. Section 600.80(c)(2)
requires licensed manufacturers to
report each adverse experience not
reported in a postmarketing 15-day
Alert report at quarterly intervals, for 3
years from the date of issuance of the
biologics license, and then at annual
intervals. The majority of these periodic
reports are submitted annually, since a
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large percentage of currently licensed
biological products have been licensed
longer than 3 years. Section 600.80(k)
requires licensed manufacturers to
maintain for a period of 10 years records
of all adverse experiences known to the
licensed manufacturer, including raw
data and any correspondence relating to
the adverse experiences. Section 600.81
requires licensed manufacturers to
submit, at an interval of every 6 months,
information about the quantity of the
product distributed under the biologics
license, including the quantity
distributed to distributors. These
distribution reports provide FDA with
important information about products
distributed under biologics licenses,
including the quantity, certain lot
numbers, labeled date of expiration, the
fill lot numbers for the total number of
dosage units of each strength or potency
distributed (e.g., 50,000 per 10-milliliter
vials), and date of release. FDA may
require the licensed manufacturer to
submit distribution reports under this
section at times other than every 6
months. Under § 600.82(a), an applicant
of a biological product or blood and
blood component must notify FDA of a
permanent discontinuance of
manufacture or an interruption in
manufacturing or disruption in supply,
as applicable. Under §§ 600.80(h)(2) and
600.81(b)(2), a licensed manufacturer
may request a temporary waiver for the
requirements under §§ 600.80(h)(1) and
600.80(b)(1), respectively. Requests for
waivers must be submitted in
accordance with § 600.90. Under
§ 600.90, a licensed manufacturer may
submit a waiver request for any
requirements that apply to the licensed
manufacturer under §§ 600.80 and
600.81. A waiver request submitted
under § 600.90 must include supporting
documentation.
Manufacturers of biological products
for human use must keep records of
each step in the manufacture and
distribution of a product, including any
recalls. These recordkeeping
requirements serve preventative and
remedial purposes by establishing
accountability and traceability in the
manufacture and distribution of
products. These requirements also
enable FDA to perform meaningful
inspections. Section 600.12 requires,
among other things, that records be
made concurrently with the
performance of each step in the
manufacture and distribution of
products. These records must be
retained for no less than 5 years after the
records of manufacture have been
completed or 6 months after the latest
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54387
expiration date for the individual
product, whichever represents a later
date. In addition, under § 600.12,
manufacturers must maintain records
relating to the sterilization of equipment
and supplies, animal necropsy records,
and records in cases of divided
manufacturing responsibility with
respect to a product. Under
§ 600.12(b)(2), manufacturers are also
required to maintain complete records
pertaining to the recall from distribution
of any product. Furthermore, § 610.18(b)
(21 CFR 610.18(b)) requires, in part, that
the results of all periodic tests for
verification of cultures and
determination of freedom from
extraneous organisms be recorded and
retained. The recordkeeping
requirements for 21 CFR 610.12(g),
610.13(a)(2), 610.18(d), 680.2(f) and
680.3(f) are approved under OMB
control number 0910–0139.
Respondents to this collection of
information include manufacturers of
biological products (including blood
and blood components) and any person
whose name appears on the label of a
licensed biological product. In table 1,
the number of respondents is based on
the estimated number of manufacturers
that are subject to those regulations or
that submitted the required information
to the Center for Biologics Evaluation
and Research and Center for Drugs
Evaluation and Research, FDA, in fiscal
year (FY) 2019. Based on information
obtained from the FDA’s database
system, there were 103 manufacturers of
biological products. This number
excludes those manufacturers who
produce Whole Blood, components of
Whole Blood, or in-vitro diagnostic
licensed products, because of the
exemption under § 600.80(m). The total
annual responses are based on the
number of submissions received by FDA
in FY 2019. There were an estimated
169,334 15-day Alert reports, 184,265
periodic reports, and 789 lot
distribution reports submitted to FDA.
The number of 15-day Alert reports for
postmarketing studies under § 600.80(e)
is included in the total number of 15day Alert reports. FDA received 63
requests from 40 manufacturers for
waivers under § 600.90 (including
§§ 600.80(h)(2) and 600.81(b)(2)), of
which 61 were granted. The hours per
response are based on FDA experience.
The burden hours required to complete
the MedWatch Form (Form FDA 3500A)
for § 600.80(c)(1), (e), and (f) are
reported under OMB control number
0910–0291.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 85, No. 170 / Tuesday, September 1, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
600.80(c)(1), 600.80(d), 600.80(e); postmarketing 15-day
Alert Reports ....................................................................
600.82; notification of discontinuance or interruption in
manufacturing ...................................................................
600.80(c)(2) periodic adverse experience reports ...............
600.81; distribution reports ..................................................
600.80(h)(2), 600.81(b)(2), 600.90; waiver requests ...........
Total ..............................................................................
1 There
Number of
responses per
respondent
Total annual
responses
Average
burden
per response
(in hours)
Total hours
103
1,644.02
169,334
1
169,334
21
103
117
40
1.67
1,788.98
6.744
1.575
35
184,265
789
63
2
28
1
1
70
5,159,420
789
63
........................
........................
........................
........................
5,329,676
are no capital costs or operating and maintenance costs associated with the information collection.
In table 2 the number of respondents
is based on the number of
manufacturers subject to those
regulations. Based on information
obtained from FDA’s database system,
there were 212 licensed manufacturers
of biological products in FY 2019.
However, the number of recordkeepers
annual average of lots released in FY
2019 (6,670), number of recalls made
(735), and total number of adverse
experience reports received (305,951) in
FY 2019. The hours per record are based
on FDA experience.
FDA estimates the burden of this
recordkeeping as follows:
listed for § 600.12(a) through (e),
excluding (b)(2), is estimated to be 109.
This number excludes manufacturers of
blood and blood components because
their burden hours for recordkeeping
have been reported under § 606.160 in
OMB control number 0910–0116. The
total annual records is based on the
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section; activity
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeper
(in hours)
Total hours
600.12 2; maintenance of Records ......................................
600.12(b)(2); recall records .................................................
600.80(c)(1) & 600.80(k); AER records ...............................
109
212
103
61.19
3,467
3,433
6,670
735
353,599
32
24
1
213,440
17,640
353,599
Total ..............................................................................
........................
........................
........................
........................
584,679
1 There
2 The
are no capital costs or operating and maintenance costs associated with this collection of information.
recordkeeping requirements in § 610.18(b) are included in the estimate for § 600.12.
The burden for this information
collection has changed since the last
OMB approval. The reporting and
recordkeeping burden has increased
mostly due to an increase in the number
of AER reports submitted to FDA and
the associated recordkeeping with these
reports.
Dated: August 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–19239 Filed 8–31–20; 8:45 am]
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BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2019–E–1918; FDA–
2019–E–1934; and FDA–2019–E–1942]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; LUMOXITI
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
SUMMARY: The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for LUMOXITI and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of
patents which claims that human
biological product.
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Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by November 2, 2020.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
March 1, 2021. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
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,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of November 2, 2020.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
DATES:
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]]>Agencies
[Federal Register Volume 85, Number 170 (Tuesday, September 1, 2020)]
[Notices]
[Pages 54385-54388]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19239]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0231]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Adverse Experience Reporting for Licensed Biological
Products; and General Records
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the proposed extension of the collection of
information concerning requirements relating to FDA's Adverse
Experience Reporting System (FAERS) for licensed biological products,
and general records associated with the manufacture and distribution of
biological products.
DATES: Submit either electronic or written comments on the collection
of information by November 2, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be
[[Page 54386]]
considered. Electronic comments must be submitted on or before November
2, 2020. The https://www.regulations.gov electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end of November 2,
2020. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or
the delivery service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-N-0231 for ``Adverse Experience Reporting for Licensed
Biological Products; and General Records.'' 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 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-45, 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.
Adverse Experience Reporting For Licensed Biological Products; and
General Records--21 CFR Part 600
OMB Control Number 0910-0308--Extension
Under the Public Health Service Act (42 U.S.C. 262), FDA may only
approve a biologics license application for a biological product that
is safe, pure, and potent. When a biological product is approved and
enters the market, the product is introduced to a larger patient
population in settings different from clinical trials. New information
generated during the postmarketing period offers further insight into
the benefits and risks of the product, and evaluation of this
information is important to ensure its safe use. FDA issued the Adverse
Experience Reporting (AER) requirements in part 600 (21 CFR part 600)
to enable FDA to take actions necessary for the protection of the
public health in response to reports of adverse experiences related to
licensed biological products. The primary purpose of FDA's FAERS is to
identify potentially serious safety problems with licensed biological
products. Although premarket testing discloses a general safety profile
of a biological product's comparatively
[[Page 54387]]
common adverse effects, the larger and more diverse patient populations
exposed to the licensed biological product provides the opportunity to
collect information on rare, latent, and long-term effects. In
addition, production and/or distribution problems have contaminated
biological products in the past. AER reports are obtained from a
variety of sources, including manufacturers, patients, physicians,
foreign regulatory agencies, and clinical investigators. Identification
of new and unexpected safety issues through the analysis of the data in
FAERS contributes directly to increased public health protection. For
example, evaluation of these safety issues enables FDA to take focused
regulatory action. Such action may include, but is not limited to,
important changes to the product's labeling (such as adding a new
warning), coordination with manufacturers to ensure adequate corrective
action is taken, and removal of a biological product from the market
when necessary.
Section 600.80(c)(1) requires licensed manufacturers or any person
whose name appears on the label of a licensed biological product to
report each adverse experience that is both serious and unexpected,
whether foreign or domestic, as soon as possible but in no case later
than 15 calendar days of initial receipt of the information by the
licensed manufacturer. These reports are known as postmarketing 15-day
Alert reports. This section also requires licensed manufacturers to
submit any followup reports within 15 calendar days of receipt of new
information or as requested by FDA, and if additional information is
not obtainable, to maintain records of the unsuccessful steps taken to
seek additional information. In addition, this section requires that a
person who submits an adverse action report to the licensed
manufacturer, rather than to FDA, maintain a record of this action.
Section 600.80(e) requires licensed manufacturers to submit a 15-day
Alert report for an adverse experience obtained from a postmarketing
clinical study only if the licensed manufacturer concludes that there
is a reasonable possibility that the product caused the adverse
experience. Section 600.80(c)(2) requires licensed manufacturers to
report each adverse experience not reported in a postmarketing 15-day
Alert report at quarterly intervals, for 3 years from the date of
issuance of the biologics license, and then at annual intervals. The
majority of these periodic reports are submitted annually, since a
large percentage of currently licensed biological products have been
licensed longer than 3 years. Section 600.80(k) requires licensed
manufacturers to maintain for a period of 10 years records of all
adverse experiences known to the licensed manufacturer, including raw
data and any correspondence relating to the adverse experiences.
Section 600.81 requires licensed manufacturers to submit, at an
interval of every 6 months, information about the quantity of the
product distributed under the biologics license, including the quantity
distributed to distributors. These distribution reports provide FDA
with important information about products distributed under biologics
licenses, including the quantity, certain lot numbers, labeled date of
expiration, the fill lot numbers for the total number of dosage units
of each strength or potency distributed (e.g., 50,000 per 10-milliliter
vials), and date of release. FDA may require the licensed manufacturer
to submit distribution reports under this section at times other than
every 6 months. Under Sec. 600.82(a), an applicant of a biological
product or blood and blood component must notify FDA of a permanent
discontinuance of manufacture or an interruption in manufacturing or
disruption in supply, as applicable. Under Sec. Sec. 600.80(h)(2) and
600.81(b)(2), a licensed manufacturer may request a temporary waiver
for the requirements under Sec. Sec. 600.80(h)(1) and 600.80(b)(1),
respectively. Requests for waivers must be submitted in accordance with
Sec. 600.90. Under Sec. 600.90, a licensed manufacturer may submit a
waiver request for any requirements that apply to the licensed
manufacturer under Sec. Sec. 600.80 and 600.81. A waiver request
submitted under Sec. 600.90 must include supporting documentation.
Manufacturers of biological products for human use must keep
records of each step in the manufacture and distribution of a product,
including any recalls. These recordkeeping requirements serve
preventative and remedial purposes by establishing accountability and
traceability in the manufacture and distribution of products. These
requirements also enable FDA to perform meaningful inspections. Section
600.12 requires, among other things, that records be made concurrently
with the performance of each step in the manufacture and distribution
of products. These records must be retained for no less than 5 years
after the records of manufacture have been completed or 6 months after
the latest expiration date for the individual product, whichever
represents a later date. In addition, under Sec. 600.12, manufacturers
must maintain records relating to the sterilization of equipment and
supplies, animal necropsy records, and records in cases of divided
manufacturing responsibility with respect to a product. Under Sec.
600.12(b)(2), manufacturers are also required to maintain complete
records pertaining to the recall from distribution of any product.
Furthermore, Sec. 610.18(b) (21 CFR 610.18(b)) requires, in part, that
the results of all periodic tests for verification of cultures and
determination of freedom from extraneous organisms be recorded and
retained. The recordkeeping requirements for 21 CFR 610.12(g),
610.13(a)(2), 610.18(d), 680.2(f) and 680.3(f) are approved under OMB
control number 0910-0139.
Respondents to this collection of information include manufacturers
of biological products (including blood and blood components) and any
person whose name appears on the label of a licensed biological
product. In table 1, the number of respondents is based on the
estimated number of manufacturers that are subject to those regulations
or that submitted the required information to the Center for Biologics
Evaluation and Research and Center for Drugs Evaluation and Research,
FDA, in fiscal year (FY) 2019. Based on information obtained from the
FDA's database system, there were 103 manufacturers of biological
products. This number excludes those manufacturers who produce Whole
Blood, components of Whole Blood, or in-vitro diagnostic licensed
products, because of the exemption under Sec. 600.80(m). The total
annual responses are based on the number of submissions received by FDA
in FY 2019. There were an estimated 169,334 15-day Alert reports,
184,265 periodic reports, and 789 lot distribution reports submitted to
FDA. The number of 15-day Alert reports for postmarketing studies under
Sec. 600.80(e) is included in the total number of 15-day Alert
reports. FDA received 63 requests from 40 manufacturers for waivers
under Sec. 600.90 (including Sec. Sec. 600.80(h)(2) and
600.81(b)(2)), of which 61 were granted. The hours per response are
based on FDA experience. The burden hours required to complete the
MedWatch Form (Form FDA 3500A) for Sec. 600.80(c)(1), (e), and (f) are
reported under OMB control number 0910-0291.
FDA estimates the burden of this collection of information as
follows:
[[Page 54388]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
600.80(c)(1), 600.80(d), 103 1,644.02 169,334 1 169,334
600.80(e); postmarketing 15-day
Alert Reports..................
600.82; notification of 21 1.67 35 2 70
discontinuance or interruption
in manufacturing...............
600.80(c)(2) periodic adverse 103 1,788.98 184,265 28 5,159,420
experience reports.............
600.81; distribution reports.... 117 6.744 789 1 789
600.80(h)(2), 600.81(b)(2), 40 1.575 63 1 63
600.90; waiver requests........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 5,329,676
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information collection.
In table 2 the number of respondents is based on the number of
manufacturers subject to those regulations. Based on information
obtained from FDA's database system, there were 212 licensed
manufacturers of biological products in FY 2019. However, the number of
recordkeepers listed for Sec. 600.12(a) through (e), excluding (b)(2),
is estimated to be 109. This number excludes manufacturers of blood and
blood components because their burden hours for recordkeeping have been
reported under Sec. 606.160 in OMB control number 0910-0116. The total
annual records is based on the annual average of lots released in FY
2019 (6,670), number of recalls made (735), and total number of adverse
experience reports received (305,951) in FY 2019. The hours per record
are based on FDA experience.
FDA estimates the burden of this recordkeeping as follows:
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per
21 CFR section; activity recordkeepers records per records recordkeeper Total hours
recordkeeper (in hours)
----------------------------------------------------------------------------------------------------------------
600.12 \2\; maintenance of 109 61.19 6,670 32 213,440
Records........................
600.12(b)(2); recall records.... 212 3,467 735 24 17,640
600.80(c)(1) & 600.80(k); AER 103 3,433 353,599 1 353,599
records........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 584,679
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ The recordkeeping requirements in Sec. 610.18(b) are included in the estimate for Sec. 600.12.
The burden for this information collection has changed since the
last OMB approval. The reporting and recordkeeping burden has increased
mostly due to an increase in the number of AER reports submitted to FDA
and the associated recordkeeping with these reports.
Dated: August 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19239 Filed 8-31-20; 8:45 am]
BILLING CODE 4164-01-P
