Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice, 66673-66678 [2019-26234]
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Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: May 25, 2012. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
May 25, 2012.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): December 17, 2015. FDA
has verified the applicant’s claim that
the biologics license application (BLA)
for ANDEXXA (BLA 125586) was
initially submitted on December 17,
2015.
3. The date the application was
approved: May 3, 2018. FDA has
verified the applicant’s claim that BLA
125586 was approved on May 3, 2018.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 661 days, 693 days,
or 1,066 days of patent term extension.
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III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
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Dated: November 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26251 Filed 12–4–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0731]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Human Cells,
Tissues, and Cellular and TissueBased Products: Establishment
Registration and Listing; Eligibility
Determination for Donors; and Current
Good Tissue Practice
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 the information
collection requirements for FDA
regulations related to human cells,
tissues, and cellular and tissue-based
products (HCT/Ps) involving
establishment registration and listing;
eligibility determination for donors; and
current good tissue practice (CGTP).
SUMMARY:
Submit either electronic or
written comments on the collection of
information by February 3, 2020.
DATES:
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 February 3,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 3, 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.
ADDRESSES:
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66673
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–
2013–N–0731 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Human
Cells, Tissues, and Cellular and TissueBased Products: Establishment
Registration and Listing; Eligibility
Determination for Donors; and Current
Good Tissue Practice.’’ Received
comments, those filed in a timely
manner (see ADDRESSES) will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
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Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
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.
Human Cells, Tissues, and Cellular and
Tissue-Based Products: Establishment
Registration and Listing; Eligibility
Determination for Donors; and Current
Good Tissue Practice
OMB Control Number 0910–0543—
Extension
Under section 361 of the Public
Health Service Act (the PHS Act) (42
U.S.C. 264), FDA may issue and enforce
regulations necessary to prevent the
introduction, transmission, or spread of
communicable diseases between the
States or possessions or from foreign
countries into the States. As derivatives
of the human body, all HCT/Ps pose
some risk of carrying pathogens that
could potentially infect recipients or
handlers. FDA has issued regulations
related to HCT/Ps involving electronic
establishment registration and listing
using an electronic system, eligibility
determination for donors, and CGTP.
I. Electronic Establishment Registration
and Listing
The regulations in part 1271 (21 CFR
part 1271) require domestic and foreign
establishments that recover, process,
store, label, package, or distribute an
HCT/P regulated solely under section
361 of the PHS Act and described in
§ 1271.10(a) (21 CFR 1271.10(a)), or that
perform screening or testing of the cell
or tissue donor, to register electronically
with FDA (§§ 1271.1(a) (21 CFR
1271.1(a)) and 1271.10(b)(1)) and submit
a list electronically of each HCT/P
manufactured (§§ 1271.1(a) and
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1271.10(b)(2)). Section 1271.21(a) (21
CFR 1271.21(a)) requires an
establishment to follow certain
procedures for initial registration and
listing of HCT/Ps, and § 1271.25(a) and
(b) (21 CFR 1271.25(a) and (b)) identifies
the required initial registration and
HCT/P listing information. Section
1271.21(b), in brief, requires an annual
update of the establishment registration.
Section 1271.21(c)(ii) requires
establishments to submit HCT/P listing
updates if a change as described in
§ 1271.25(c) has occurred. Section
1271.25(c) identifies the required HCT/
P listing update information. Section
1271.26 (21 CFR 1271.26) requires
establishments to submit an amendment
if ownership or location of the
establishment changes, or if there is a
change in the U.S. agent’s name,
address, telephone number, or email
address. FDA requires the use of an
electronic registration and listing system
entitled ‘‘eHCTERs’’ (Electronic Human
Cell and Tissue Establishment
Registration System) to submit the
required information (§§ 1271.10,
1271.21, 1271.25, and 1271.26)). Under
§ 1271.23 (21 CFR 1271.23),
manufacturers may request a waiver
from the requirements in 21 CFR
1271.22 that information must be
provided to FDA in electronic format.
II. Eligibility Determination for Donors
In brief, FDA requires certain HCT/P
establishments described in § 1271.1(b)
to determine donor eligibility based on
donor screening and testing for relevant
communicable disease agents and
diseases except as provided under 21
CFR 1271.90. The documented
determination of a donor’s eligibility is
made by a responsible person as defined
in § 1271.3(t) (21 CFR 1271.3(t)) and is
based on the results of required donor
screening, which includes a donor
medical history interview (defined in
§ 1271.3(n)), and testing (§ 1271.50(a)
(21 CFR 1271.50(a)). Certain records
must accompany an HCT/P once the
donor-eligibility determination has been
made (§ 1271.55(a) (21 CFR 1271.55(a))).
This requirement applies both to an
HCT/P from a donor who is determined
to be eligible as well as to an HCT/P
from a donor who is determined to be
ineligible or where the donor-eligibility
determination is not complete if there is
a documented urgent medical need, as
defined in § 1271.3(u) (§§ 1271.60 and
1271.65 (21 CFR 1271.60 and 1271.65)).
Once the donor-eligibility determination
has been made, the HCT/P must be
accompanied by a summary of records
used to make the donor-eligibility
determination (§ 1271.55(b)), and a
statement whether, based on the results
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of the screening and testing of the
donor, the donor is determined to be
eligible or ineligible (§ 1271.55(a)(2)).
Records used in determining the
eligibility of a donor, i.e., results and
interpretations of testing for relevant
communicable disease agents, the
donor-eligibility determination, the
name and address of the testing
laboratory or laboratories, and the name
of the responsible person (defined in
§ 1271.3(t)) who made the donoreligibility determination and the date of
the determination, must be maintained
(§ 1271.55(d)(1)). If any information on
the donor is not in English, the original
record must be maintained and
translated to English and accompanied
by a statement of authenticity by the
translator (§ 1271.55(d)(2)). HCT/P
establishments must retain the records
pertaining to a particular HCT/P at least
10 years after the date of its
administration, or, if the date of
administration is not known, then at
least 10 years after the date of the HCT/
P’s distribution, disposition, or
expiration, whichever is latest
(§ 1271.55(d)(4)).
When a product is shipped in
quarantine, as defined in § 1271.3(q),
before completion of screening and
testing, the HCT/P must be
accompanied by records identifying the
donor (e.g., by a distinct identification
code affixed to the HCT/P container)
stating that the donor-eligibility
determination has not been completed
and stating that the product must not be
implanted, transplanted, infused, or
transferred until completion of the
donor-eligibility determination, except
in cases of urgent medical need, as
defined in § 1271.3(u) (§ 1271.60(c)).
When an HCT/P is used in cases of
documented urgent medical need, the
results of any completed donor
screening and testing, and a list of any
required screening and testing that has
not yet been completed also must
accompany the HCT/P (§ 1271.60(d)(2)).
When a HCT/P is used in cases of urgent
medical need or from a donor who has
been determined to be ineligible (as
permitted under § 1271.65),
documentation by the HCT/P
establishment is required, showing that
the recipient’s physician received
notification that the testing and
screening were not complete (in cases of
urgent medical need), and upon the
completion of the donor-eligibility
determination, of the results of the
determination (§§ 1271.60(d)(3) and (4),
and 1271.65(b)(3)).
An HCT/P establishment is also
required to establish and maintain
procedures for all steps that are
performed in determining eligibility
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(§ 1271.47(a) (21 CFR 1271.47(a)),
including the use of a product from a
donor of viable, leukocyte-rich cells or
tissue testing reactive for
cytomegalovirus (§ 1271.85(b)(2) (21
CFR 1271.85(b)(2))). The HCT/P
establishment must record and justify
any departure from a procedure relevant
to preventing risks of communicable
disease transmission at the time of its
occurrence (§ 1271.47(d)).
III. Current Good Tissue Practice
(CGTP)
FDA requires HCT/P establishments
that manufacture HCT/Ps that are
regulated solely under section 361 of the
PHS Act to follow CGTP (§ 1271.1(b)).
Section 1271.155(a) (21 CFR
1271.155(a)) permits the submission of
a request for FDA approval of an
exemption from or an alternative to any
requirement in subpart C or D of part
1271. Section 1271.290(c) (21 CFR
1271.290(c)) requires establishments to
affix a distinct identification code to
each HCT/P that they manufacture that
relates the HCT/P to the donor and to all
records pertaining to the HCT/P.
Whenever an establishment distributes
an HCT/P to a consignee, § 1271.290(f)
requires the establishment to inform the
consignee, in writing, of the product
tracking requirements and the methods
the establishment uses to fulfill these
requirements. Non-reproductive HCT/P
establishments described in § 1271.10
are required under § 1271.350(a)(1) and
(3) (21 CFR 1271.350(a)(1) and (3)) to
investigate and report to FDA adverse
reactions (defined in § 1271.3(y)) using
Form FDA–3500A (§ 1271.350(a)(2)).
Form FDA–3500A is approved under
OMB control number 0910–0291.
Section 1271.370(b) and (c) (21 CFR
1271.370(b) and (c)) requires
establishments to include specific
information either on the HCT/P label or
with the HCT/P.
The standard operating procedures
(SOP) provisions under part 1271
include the following: (1) Section
1271.160(b)(2) (21 CFR 1271.160(b)(2))
(receiving, investigating, evaluating, and
documenting information relating to
core CGTP requirements, including
complaints, and for sharing information
with consignees and other
establishments); (2) § 1271.180(a) (21
CFR 1271.180(a)) (to meet core CGTP
requirements for all steps performed in
the manufacture of HCT/Ps); (3)
§ 1271.190(d)(1) (21 CFR 1271.190(d)(1))
(facility cleaning and sanitization); (4)
§ 1271.200(b) (21 CFR 1271.200(b))
(cleaning, sanitizing, and maintenance
of equipment); (5) § 1271.200(c)
(calibration of equipment); (6)
§ 1271.230(a) and (c) (21 CFR
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1271.230(a) and (c)) (validation of a
process and review and evaluation of
changes to a validated process); (7)
§ 1271.250(a) (21 CFR 1271.250(a))
(controls for labeling HCT/Ps); (8)
§ 1271.265(e) (21 CFR 1271.265(e))
(receipt, predistribution shipment,
availability for distribution, and
packaging and shipping of HCT/Ps); (9)
§ 1271.265(f) (suitable for return to
inventory); (10) § 1271.270(b) (21 CFR
1271.270(b)) (records management
system); (11) § 1271.290(b)(1) (21 CFR
1271.290(b)(1)) (system of HCT/P
tracking); and (12) § 1271.320(a) (21 CFR
1271.320(a)) (review, evaluation, and
documentation of complaints as defined
in § 1271.3(aa)).
Section 1271.155(f) requires an
establishment operating under the terms
of an exemption or alternative to
maintain documentation of FDA’s grant
of the exemption or approval and the
date on which it began operating under
the terms of the exemption or
alternative. Section 1271.160(b)(3)
requires the quality program of an
establishment that performs any step in
the manufacture of HCT/Ps to document
corrective actions relating to core CGTP
requirements. Section 1271.160(b)(6)
requires documentation of HCT/P
deviations. Section 1271.160(d)
requires, in brief, documentation of
validation of computer software if the
establishment relies upon it to comply
with core CGTP requirements. Section
1271.190(d)(2) requires documentation
of all cleaning and sanitation activities
performed to prevent contamination of
HCT/Ps. Section 1271.195(d) requires
documentation of environmental control
and monitoring activities. Section
1271.200(e) requires documentation of
all equipment maintenance, cleaning,
sanitizing, calibration, and other
activities. Section 1271.210(d) (21 CFR
1271.210(d)) requires, in brief,
documentation of the receipt,
verification, and use of each supply or
reagent. Section 1271.230(a) requires
documentation of validation activities
and results when the results of
processing described in 21 CFR
1271.220 cannot be fully verified by
subsequent inspection and tests. Section
1271.230(c) requires that when changes
to a validated process subject to
§ 1271.230(a) occur, documentation of
the review and evaluation of the process
and revalidation, if necessary, must
occur. Section 1271.260(d) and (e) (21
CFR 1271.260(d) and (e)) requires
documentation of any corrective action
taken when proper storage conditions
are not met and documentation of the
storage temperature for HCT/Ps. Section
1271.265(c)(1) requires documentation
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that all release criteria have been met
before distribution of an HCT/P. Section
1271.265(c)(3) requires documentation
of any departure from a procedure
relevant to preventing risks of
communicable disease transmission at
the time of occurrence. Section
1271.265(e) requires documentation of
the activities in paragraphs (a) through
(d) of that section, which must include
identification of the HCT/P and the
establishment that supplied the HCT/P,
activities performed and the results of
each activity, date(s) of activity,
quantity of HCT/P subject to the
activity, and disposition of the HCT/P.
Section 1271.270(a) requires
documentation of each step in
manufacturing required in part 1271,
subparts C and D. Section 1271.270(e)
requires documentation of the name and
address, and a list of responsibilities of
any establishment that performs a
manufacturing step for the
establishment. Section 1271.290(d) and
(e) require documentation of a method
for recording the distinct identification
code and type of each HCT/P
distributed to a consignee to enable
tracking from the consignee to the donor
and to enable tracking from the donor to
the consignee or final disposition.
Section 1271.320(b) requires an
establishment to maintain a record of
each complaint that it receives. The
complaint file must contain sufficient
information about each complaint for
proper review and evaluation of the
complaint and for determining whether
the complaint is an isolated event or
represents a trend.
Section 1271.420(a) (21 CFR
1271.420(a)) requires importers of HCT/
Ps to notify the FDA District Director
having jurisdiction over the port of
entry through which the HCT/Ps are
offered for import. The HCT/Ps must be
held intact or transported under
quarantine until they are inspected and
released by FDA.
Respondents to this information
collection are establishments that
recover, process, store, label, package or
distribute any HCT/P that is regulated
solely under section 361 of the PHS Act
or perform donor screening or testing.
The estimates provided below are based
on most recent available information
from FDA’s database system and trade
organizations. The hours per response
and hours per record are based on data
provided by the Eastern Research
Group, or FDA experience with similar
recordkeeping or reporting
requirements.
There are an estimated 2,736 HCT/P
establishments (conventional tissue, eye
tissue, peripheral blood stem cell, stem
cell products from cord blood,
reproductive tissue, and sperm banks),
including 1,004 manufacturers of HCT/
Ps regulated under the Federal Food,
Drug, and Cosmetic Act and section 351
of the PHS Act (42 U.S.C 262), that have
registered and listed with FDA. In
addition, we estimate that 193 new
establishments have registered with
FDA (§§ 1271.10(b)(1) and (2) and
1271.25(a) and (b)). There are an
estimated 1,062 listing updates
(§§ 1271.10(b)(2), 1271.21(c)(ii), and
1271.25(c)) and 358 location/ownership
amendments (§ 1271.26).
Under § 1271.23, FDA estimates an
average of one waiver request annually.
Under § 1271.55(a), an estimated total
of 2,594,415 HCT/Ps (which include
conventional tissues, eye tissues,
hematopoietic stem cells/progenitor
cells, and reproductive cells and
tissues), and an estimated total of
2,454,415 non-reproductive cells and
tissues (total HCT/Ps minus
reproductive cells and tissues) are
distributed per year by an estimated
1,632 establishments (2,736¥1,104 =
1,632).
Under § 1271.60(c) and (d)(2), FDA
estimates that 1,611 establishments
shipped an estimated 572,000 HCT/P
under quarantine, and that an estimated
15 establishments requested 64
exemptions from or alternative to any
requirement under part 1271, subpart C
or D, specifically under § 1271.155(a).
Under §§ 1271.290(c) and 1271.370(b)
and (c), the estimated 2,109 nonreproductive HCT/P establishments
label each of their 2,441,644 HCT/Ps
with certain information. These
establishments are also required to
inform their consignees in writing of the
requirements for tracking and of their
established tracking system under
§ 1271.290(f).
FDA estimates 13 HCT/P
establishments submitted 188 adverse
reaction reports with 162 involving a
communicable disease
(§ 1271.350(a)(1)).
FDA estimates that 193 new
establishments will create SOPs, and
that 2,736 establishments will review
and revise existing SOPs annually.
FDA estimates that 1,368 HCT/P
establishments (2,736 × 50 percent =
1,368) and 1,055 non-reproductive HCT/
P establishments (2,109 × 50 percent =
1,055) record and justify a departure
from the procedures (§§ 1271.47(d) and
1271.265(c)(3)).
Under § 1271.50(a), HCT/P
establishments are required to have a
documented medical history interview
about the donor’s medical history and
relevant social behavior as part of the
donor’s relevant medical records for
each of the estimated total of 109,019
donors (which include conventional
tissue donors, eye tissue donors,
peripheral and cord blood stem cell
donors, and reproductive cell and tissue
donors), and the estimated total of
103,419 non-reproductive cells and
tissue donors (total donors minus
reproductive cell and tissue donors).
FDA estimates that 821 HCT/P
establishments (2,736 × 30 percent =
821) document an urgent medical need
of the product to notify the physician
using the HCT/P (§§ 1271.60(d)(3) and
1271.65(b)(3)).
FDA also estimates that 2,189 HCT/P
establishments (2,736 × 80 percent =
2,189) have to maintain records for an
average of 2 contract establishments to
perform their manufacturing process
(§ 1271.270(e) and 1,687 HCT/P
establishments (2,109 × 80 percent =
1,687) maintain an average of 5
complaint records annually
(§ 1271.320(b)).
FDA estimates that under
§ 1271.420(a), 200 establishments will
submit 560 reports of HCT/Ps offered for
imports.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
jbell on DSKJLSW7X2PROD with NOTICES
21 CFR part 1271; human cells, tissues, and
cellular and tissue-based products
1271.10(b)(1) and 1271.21(b) 2 ............................
1271.10(b)(1) and (2), 1271.21(a), and
1271.25(a) and (b) 2.
1271.10(b)(2), 1271.21(c)(2)(ii) and 1271.25(c) 2
1271.23 .................................................................
1271.26 2 ...............................................................
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PO 00000
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours 3
2,736
193
1
1
2,736
193
0.5 (30 minutes) ...........
0.75 (45 minutes) .........
1,368
145
1,062
1
358
1
1
1
1,062
1
358
0.5 (30 minutes) ...........
1 ....................................
0.25 (15 minutes) .........
531
1
90
Frm 00028
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Sfmt 4703
E:\FR\FM\05DEN1.SGM
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Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
66677
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR part 1271; human cells, tissues, and
cellular and tissue-based products
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours 3
1271.155(a) ...........................................................
1271.350(a)(1) and (3) .........................................
1271.420(a) ...........................................................
15
13
200
4.27
14.46
2.8
64
188
560
3 ....................................
1 ....................................
0.25 (15 minutes) .........
192
188
140
Total ...............................................................
........................
........................
........................
.......................................
2,655
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
eHCTERS.
3 Rounded to the nearest whole number.
2 Using
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR part 1271; human cells, tissues, and
cellular and tissue-based products
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours 3
New SOPs 2 ..........................................................
SOP Update 2 .......................................................
1271.47(d) .............................................................
1271.50(a) .............................................................
1271.55(d)(1) ........................................................
1271.55(d)(2) ........................................................
1271.55(d)(4) ........................................................
1271.60(d)(3) and (4) 1271.65(b)(3)(iii) ................
1271.155(f) ............................................................
1271.160(b)(3) and (6) .........................................
1271.160(d) ...........................................................
1271.190(d)(2) ......................................................
1271.195(d) ...........................................................
1271.200(e) ...........................................................
1271.210(d) ...........................................................
1271.230(a) ...........................................................
1271.230(c) ...........................................................
1271.260(d) ...........................................................
1271.260(e) ...........................................................
1271.265(c)(1) ......................................................
1271.265(c)(3) ......................................................
1271.265(e) ...........................................................
1271.270(a) ...........................................................
1271.270(e) ...........................................................
1271.290(d) and (e) ..............................................
1271.320(b) ...........................................................
193
2,736
1,368
2,736
2,736
2,736
2,736
821
15
2,109
2,109
2,109
2,109
2,109
2,109
2,109
2,109
2,109
2,109
2,109
1,055
2,109
2,109
2,189
2,109
1,687
1
1
1
39.846
39.846
1
1
1
4.27
12
12
12
12
12
12
12
1
12
365
1,163.781
1
1,163.781
1,163.781
2
49.037
5
193
2,736
1,368
109,019
109,019
2,736
2,736
821
64
25,308
25,308
25,308
25,308
25,308
25,308
25,308
2,109
25,308
769,785
2,454,415
1,055
2,454,415
2,454,415
4,378
103,419
8,435
48 ..................................
24 ..................................
1 ....................................
5 ....................................
1 ....................................
1 ....................................
120 ................................
2 ....................................
0.25 (15 minutes) .........
1 ....................................
1 ....................................
1 ....................................
1 ....................................
1 ....................................
1 ....................................
1 ....................................
1 ....................................
0.25 (15 minutes) .........
0.083 (5 minutes) .........
0.083 (5 minutes) .........
1 ....................................
0.083 (5 minutes) .........
0.25 (15 minutes) .........
0.5 (30 minutes) ...........
0.25 (15 minutes) .........
1 ....................................
9,264
65,664
1,368
545,095
109,019
2,736
328,320
1,642
16
25,308
25,308
25,308
25,308
25,308
25,308
25,308
2,109
6,327
63,892
203,716
1,055
203,716
613,604
2,189
25,855
8,435
Total ...............................................................
........................
........................
........................
.......................................
2,371,178
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b), 1271.200(c), 1271.230(a),
1271.250(a), and 1271.265(e).
3 Rounded to the nearest whole number.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
jbell on DSKJLSW7X2PROD with NOTICES
21 CFR part 1271; human cells, tissues, and
cellular and tissue-based products
Number of
disclosures
per respondent
Number of
respondents
Total annual
disclosures
Average burden
per disclosure
Total hours
1271.55(a) ..........................................................
1271.60(c) and (d)(2) .........................................
1271.290(c) ........................................................
1271.290(f) .........................................................
1271.370(b) and (c) ...........................................
1,632
1,611
2,109
2,109
2,109
1,589.715
355.06
1,163.781
1
1,163.781
2,594,415
572,000
2,454,415
2,109
2,454,415
0.5 (30 minutes) ..........
0.5 (30 minutes) ..........
0.083 (5 minutes) ........
1 ..................................
0.25 (15 minutes) ........
1,297,208
286,000
203,716
2,109
613,604
Total ............................................................
........................
............................
........................
.....................................
2,402,637
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Rounded to the nearest whole number.
Our estimated burden for the
information collection reflects an
overall increase of 628,585 hours (111
VerDate Sep<11>2014
17:38 Dec 04, 2019
Jkt 250001
reporting burden hours; 305,118
recordkeeping hours; and 323,356
disclosure burden hours) and a
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
corresponding increase of annual
responses, annual records, and annual
disclosures. We attribute this
E:\FR\FM\05DEN1.SGM
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66678
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
adjustment to an increase in the number
HCT/P establishments and an increase
in the number HCT/Ps distributed over
the past few years.
Dated: November 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26234 Filed 12–4–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1619]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements
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 the information
collection provisions of FDA’s
regulations regarding current good
manufacturing practice (CGMP) for
dietary supplements.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by February 3, 2020.
DATES:
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 February 3,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 3, 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.
jbell on DSKJLSW7X2PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
17:38 Dec 04, 2019
Jkt 250001
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–
2013–N–1619 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Current
Good Manufacturing Practice in
Manufacturing, Packaging, Labeling or
Holding Operations for Dietary
Supplements.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
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
proposed collection of information,
including each proposed extension of an
E:\FR\FM\05DEN1.SGM
05DEN1
]]>Agencies
[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Notices]
[Pages 66673-66678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26234]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0731]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based
Products: Establishment Registration and Listing; Eligibility
Determination for Donors; and Current Good Tissue Practice
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 information collection requirements for
FDA regulations related to human cells, tissues, and cellular and
tissue-based products (HCT/Ps) involving establishment registration and
listing; eligibility determination for donors; and current good tissue
practice (CGTP).
DATES: Submit either electronic or written comments on the collection
of information by February 3, 2020.
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 February 3, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 3, 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-2013-N-0731 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Human Cells, Tissues, and
Cellular and Tissue-Based Products: Establishment Registration and
Listing; Eligibility Determination for Donors; and Current Good Tissue
Practice.'' Received comments, those filed in a timely manner (see
ADDRESSES) will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential
[[Page 66674]]
information that you do not wish to be made publicly available, submit
your comments only as a written/paper submission. You should submit two
copies total. One copy will include the information you claim to be
confidential with a heading or cover note that states ``THIS DOCUMENT
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy,
including the claimed confidential information, in its consideration of
comments. The second copy, which will have the claimed confidential
information redacted/blacked out, will be available for public viewing
and posted on https://www.regulations.gov. Submit both copies to the
Dockets Management Staff. If you do not wish your name and contact
information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.
Human Cells, Tissues, and Cellular and Tissue-Based Products:
Establishment Registration and Listing; Eligibility Determination for
Donors; and Current Good Tissue Practice
OMB Control Number 0910-0543--Extension
Under section 361 of the Public Health Service Act (the PHS Act)
(42 U.S.C. 264), FDA may issue and enforce regulations necessary to
prevent the introduction, transmission, or spread of communicable
diseases between the States or possessions or from foreign countries
into the States. As derivatives of the human body, all HCT/Ps pose some
risk of carrying pathogens that could potentially infect recipients or
handlers. FDA has issued regulations related to HCT/Ps involving
electronic establishment registration and listing using an electronic
system, eligibility determination for donors, and CGTP.
I. Electronic Establishment Registration and Listing
The regulations in part 1271 (21 CFR part 1271) require domestic
and foreign establishments that recover, process, store, label,
package, or distribute an HCT/P regulated solely under section 361 of
the PHS Act and described in Sec. 1271.10(a) (21 CFR 1271.10(a)), or
that perform screening or testing of the cell or tissue donor, to
register electronically with FDA (Sec. Sec. 1271.1(a) (21 CFR
1271.1(a)) and 1271.10(b)(1)) and submit a list electronically of each
HCT/P manufactured (Sec. Sec. 1271.1(a) and 1271.10(b)(2)). Section
1271.21(a) (21 CFR 1271.21(a)) requires an establishment to follow
certain procedures for initial registration and listing of HCT/Ps, and
Sec. 1271.25(a) and (b) (21 CFR 1271.25(a) and (b)) identifies the
required initial registration and HCT/P listing information. Section
1271.21(b), in brief, requires an annual update of the establishment
registration. Section 1271.21(c)(ii) requires establishments to submit
HCT/P listing updates if a change as described in Sec. 1271.25(c) has
occurred. Section 1271.25(c) identifies the required HCT/P listing
update information. Section 1271.26 (21 CFR 1271.26) requires
establishments to submit an amendment if ownership or location of the
establishment changes, or if there is a change in the U.S. agent's
name, address, telephone number, or email address. FDA requires the use
of an electronic registration and listing system entitled ``eHCTERs''
(Electronic Human Cell and Tissue Establishment Registration System) to
submit the required information (Sec. Sec. 1271.10, 1271.21, 1271.25,
and 1271.26)). Under Sec. 1271.23 (21 CFR 1271.23), manufacturers may
request a waiver from the requirements in 21 CFR 1271.22 that
information must be provided to FDA in electronic format.
II. Eligibility Determination for Donors
In brief, FDA requires certain HCT/P establishments described in
Sec. 1271.1(b) to determine donor eligibility based on donor screening
and testing for relevant communicable disease agents and diseases
except as provided under 21 CFR 1271.90. The documented determination
of a donor's eligibility is made by a responsible person as defined in
Sec. 1271.3(t) (21 CFR 1271.3(t)) and is based on the results of
required donor screening, which includes a donor medical history
interview (defined in Sec. 1271.3(n)), and testing (Sec. 1271.50(a)
(21 CFR 1271.50(a)). Certain records must accompany an HCT/P once the
donor-eligibility determination has been made (Sec. 1271.55(a) (21 CFR
1271.55(a))). This requirement applies both to an HCT/P from a donor
who is determined to be eligible as well as to an HCT/P from a donor
who is determined to be ineligible or where the donor-eligibility
determination is not complete if there is a documented urgent medical
need, as defined in Sec. 1271.3(u) (Sec. Sec. 1271.60 and 1271.65 (21
CFR 1271.60 and 1271.65)). Once the donor-eligibility determination has
been made, the HCT/P must be accompanied by a summary of records used
to make the donor-eligibility determination (Sec. 1271.55(b)), and a
statement whether, based on the results
[[Page 66675]]
of the screening and testing of the donor, the donor is determined to
be eligible or ineligible (Sec. 1271.55(a)(2)). Records used in
determining the eligibility of a donor, i.e., results and
interpretations of testing for relevant communicable disease agents,
the donor-eligibility determination, the name and address of the
testing laboratory or laboratories, and the name of the responsible
person (defined in Sec. 1271.3(t)) who made the donor-eligibility
determination and the date of the determination, must be maintained
(Sec. 1271.55(d)(1)). If any information on the donor is not in
English, the original record must be maintained and translated to
English and accompanied by a statement of authenticity by the
translator (Sec. 1271.55(d)(2)). HCT/P establishments must retain the
records pertaining to a particular HCT/P at least 10 years after the
date of its administration, or, if the date of administration is not
known, then at least 10 years after the date of the HCT/P's
distribution, disposition, or expiration, whichever is latest (Sec.
1271.55(d)(4)).
When a product is shipped in quarantine, as defined in Sec.
1271.3(q), before completion of screening and testing, the HCT/P must
be accompanied by records identifying the donor (e.g., by a distinct
identification code affixed to the HCT/P container) stating that the
donor-eligibility determination has not been completed and stating that
the product must not be implanted, transplanted, infused, or
transferred until completion of the donor-eligibility determination,
except in cases of urgent medical need, as defined in Sec. 1271.3(u)
(Sec. 1271.60(c)). When an HCT/P is used in cases of documented urgent
medical need, the results of any completed donor screening and testing,
and a list of any required screening and testing that has not yet been
completed also must accompany the HCT/P (Sec. 1271.60(d)(2)). When a
HCT/P is used in cases of urgent medical need or from a donor who has
been determined to be ineligible (as permitted under Sec. 1271.65),
documentation by the HCT/P establishment is required, showing that the
recipient's physician received notification that the testing and
screening were not complete (in cases of urgent medical need), and upon
the completion of the donor-eligibility determination, of the results
of the determination (Sec. Sec. 1271.60(d)(3) and (4), and
1271.65(b)(3)).
An HCT/P establishment is also required to establish and maintain
procedures for all steps that are performed in determining eligibility
(Sec. 1271.47(a) (21 CFR 1271.47(a)), including the use of a product
from a donor of viable, leukocyte-rich cells or tissue testing reactive
for cytomegalovirus (Sec. 1271.85(b)(2) (21 CFR 1271.85(b)(2))). The
HCT/P establishment must record and justify any departure from a
procedure relevant to preventing risks of communicable disease
transmission at the time of its occurrence (Sec. 1271.47(d)).
III. Current Good Tissue Practice (CGTP)
FDA requires HCT/P establishments that manufacture HCT/Ps that are
regulated solely under section 361 of the PHS Act to follow CGTP (Sec.
1271.1(b)). Section 1271.155(a) (21 CFR 1271.155(a)) permits the
submission of a request for FDA approval of an exemption from or an
alternative to any requirement in subpart C or D of part 1271. Section
1271.290(c) (21 CFR 1271.290(c)) requires establishments to affix a
distinct identification code to each HCT/P that they manufacture that
relates the HCT/P to the donor and to all records pertaining to the
HCT/P. Whenever an establishment distributes an HCT/P to a consignee,
Sec. 1271.290(f) requires the establishment to inform the consignee,
in writing, of the product tracking requirements and the methods the
establishment uses to fulfill these requirements. Non-reproductive HCT/
P establishments described in Sec. 1271.10 are required under Sec.
1271.350(a)(1) and (3) (21 CFR 1271.350(a)(1) and (3)) to investigate
and report to FDA adverse reactions (defined in Sec. 1271.3(y)) using
Form FDA-3500A (Sec. 1271.350(a)(2)). Form FDA-3500A is approved under
OMB control number 0910-0291. Section 1271.370(b) and (c) (21 CFR
1271.370(b) and (c)) requires establishments to include specific
information either on the HCT/P label or with the HCT/P.
The standard operating procedures (SOP) provisions under part 1271
include the following: (1) Section 1271.160(b)(2) (21 CFR
1271.160(b)(2)) (receiving, investigating, evaluating, and documenting
information relating to core CGTP requirements, including complaints,
and for sharing information with consignees and other establishments);
(2) Sec. 1271.180(a) (21 CFR 1271.180(a)) (to meet core CGTP
requirements for all steps performed in the manufacture of HCT/Ps); (3)
Sec. 1271.190(d)(1) (21 CFR 1271.190(d)(1)) (facility cleaning and
sanitization); (4) Sec. 1271.200(b) (21 CFR 1271.200(b)) (cleaning,
sanitizing, and maintenance of equipment); (5) Sec. 1271.200(c)
(calibration of equipment); (6) Sec. 1271.230(a) and (c) (21 CFR
1271.230(a) and (c)) (validation of a process and review and evaluation
of changes to a validated process); (7) Sec. 1271.250(a) (21 CFR
1271.250(a)) (controls for labeling HCT/Ps); (8) Sec. 1271.265(e) (21
CFR 1271.265(e)) (receipt, predistribution shipment, availability for
distribution, and packaging and shipping of HCT/Ps); (9) Sec.
1271.265(f) (suitable for return to inventory); (10) Sec. 1271.270(b)
(21 CFR 1271.270(b)) (records management system); (11) Sec.
1271.290(b)(1) (21 CFR 1271.290(b)(1)) (system of HCT/P tracking); and
(12) Sec. 1271.320(a) (21 CFR 1271.320(a)) (review, evaluation, and
documentation of complaints as defined in Sec. 1271.3(aa)).
Section 1271.155(f) requires an establishment operating under the
terms of an exemption or alternative to maintain documentation of FDA's
grant of the exemption or approval and the date on which it began
operating under the terms of the exemption or alternative. Section
1271.160(b)(3) requires the quality program of an establishment that
performs any step in the manufacture of HCT/Ps to document corrective
actions relating to core CGTP requirements. Section 1271.160(b)(6)
requires documentation of HCT/P deviations. Section 1271.160(d)
requires, in brief, documentation of validation of computer software if
the establishment relies upon it to comply with core CGTP requirements.
Section 1271.190(d)(2) requires documentation of all cleaning and
sanitation activities performed to prevent contamination of HCT/Ps.
Section 1271.195(d) requires documentation of environmental control and
monitoring activities. Section 1271.200(e) requires documentation of
all equipment maintenance, cleaning, sanitizing, calibration, and other
activities. Section 1271.210(d) (21 CFR 1271.210(d)) requires, in
brief, documentation of the receipt, verification, and use of each
supply or reagent. Section 1271.230(a) requires documentation of
validation activities and results when the results of processing
described in 21 CFR 1271.220 cannot be fully verified by subsequent
inspection and tests. Section 1271.230(c) requires that when changes to
a validated process subject to Sec. 1271.230(a) occur, documentation
of the review and evaluation of the process and revalidation, if
necessary, must occur. Section 1271.260(d) and (e) (21 CFR 1271.260(d)
and (e)) requires documentation of any corrective action taken when
proper storage conditions are not met and documentation of the storage
temperature for HCT/Ps. Section 1271.265(c)(1) requires documentation
[[Page 66676]]
that all release criteria have been met before distribution of an HCT/
P. Section 1271.265(c)(3) requires documentation of any departure from
a procedure relevant to preventing risks of communicable disease
transmission at the time of occurrence. Section 1271.265(e) requires
documentation of the activities in paragraphs (a) through (d) of that
section, which must include identification of the HCT/P and the
establishment that supplied the HCT/P, activities performed and the
results of each activity, date(s) of activity, quantity of HCT/P
subject to the activity, and disposition of the HCT/P. Section
1271.270(a) requires documentation of each step in manufacturing
required in part 1271, subparts C and D. Section 1271.270(e) requires
documentation of the name and address, and a list of responsibilities
of any establishment that performs a manufacturing step for the
establishment. Section 1271.290(d) and (e) require documentation of a
method for recording the distinct identification code and type of each
HCT/P distributed to a consignee to enable tracking from the consignee
to the donor and to enable tracking from the donor to the consignee or
final disposition. Section 1271.320(b) requires an establishment to
maintain a record of each complaint that it receives. The complaint
file must contain sufficient information about each complaint for
proper review and evaluation of the complaint and for determining
whether the complaint is an isolated event or represents a trend.
Section 1271.420(a) (21 CFR 1271.420(a)) requires importers of HCT/
Ps to notify the FDA District Director having jurisdiction over the
port of entry through which the HCT/Ps are offered for import. The HCT/
Ps must be held intact or transported under quarantine until they are
inspected and released by FDA.
Respondents to this information collection are establishments that
recover, process, store, label, package or distribute any HCT/P that is
regulated solely under section 361 of the PHS Act or perform donor
screening or testing. The estimates provided below are based on most
recent available information from FDA's database system and trade
organizations. The hours per response and hours per record are based on
data provided by the Eastern Research Group, or FDA experience with
similar recordkeeping or reporting requirements.
There are an estimated 2,736 HCT/P establishments (conventional
tissue, eye tissue, peripheral blood stem cell, stem cell products from
cord blood, reproductive tissue, and sperm banks), including 1,004
manufacturers of HCT/Ps regulated under the Federal Food, Drug, and
Cosmetic Act and section 351 of the PHS Act (42 U.S.C 262), that have
registered and listed with FDA. In addition, we estimate that 193 new
establishments have registered with FDA (Sec. Sec. 1271.10(b)(1) and
(2) and 1271.25(a) and (b)). There are an estimated 1,062 listing
updates (Sec. Sec. 1271.10(b)(2), 1271.21(c)(ii), and 1271.25(c)) and
358 location/ownership amendments (Sec. 1271.26).
Under Sec. 1271.23, FDA estimates an average of one waiver request
annually.
Under Sec. 1271.55(a), an estimated total of 2,594,415 HCT/Ps
(which include conventional tissues, eye tissues, hematopoietic stem
cells/progenitor cells, and reproductive cells and tissues), and an
estimated total of 2,454,415 non-reproductive cells and tissues (total
HCT/Ps minus reproductive cells and tissues) are distributed per year
by an estimated 1,632 establishments (2,736-1,104 = 1,632).
Under Sec. 1271.60(c) and (d)(2), FDA estimates that 1,611
establishments shipped an estimated 572,000 HCT/P under quarantine, and
that an estimated 15 establishments requested 64 exemptions from or
alternative to any requirement under part 1271, subpart C or D,
specifically under Sec. 1271.155(a).
Under Sec. Sec. 1271.290(c) and 1271.370(b) and (c), the estimated
2,109 non-reproductive HCT/P establishments label each of their
2,441,644 HCT/Ps with certain information. These establishments are
also required to inform their consignees in writing of the requirements
for tracking and of their established tracking system under Sec.
1271.290(f).
FDA estimates 13 HCT/P establishments submitted 188 adverse
reaction reports with 162 involving a communicable disease (Sec.
1271.350(a)(1)).
FDA estimates that 193 new establishments will create SOPs, and
that 2,736 establishments will review and revise existing SOPs
annually.
FDA estimates that 1,368 HCT/P establishments (2,736 x 50 percent =
1,368) and 1,055 non-reproductive HCT/P establishments (2,109 x 50
percent = 1,055) record and justify a departure from the procedures
(Sec. Sec. 1271.47(d) and 1271.265(c)(3)).
Under Sec. 1271.50(a), HCT/P establishments are required to have a
documented medical history interview about the donor's medical history
and relevant social behavior as part of the donor's relevant medical
records for each of the estimated total of 109,019 donors (which
include conventional tissue donors, eye tissue donors, peripheral and
cord blood stem cell donors, and reproductive cell and tissue donors),
and the estimated total of 103,419 non-reproductive cells and tissue
donors (total donors minus reproductive cell and tissue donors).
FDA estimates that 821 HCT/P establishments (2,736 x 30 percent =
821) document an urgent medical need of the product to notify the
physician using the HCT/P (Sec. Sec. 1271.60(d)(3) and 1271.65(b)(3)).
FDA also estimates that 2,189 HCT/P establishments (2,736 x 80
percent = 2,189) have to maintain records for an average of 2 contract
establishments to perform their manufacturing process (Sec.
1271.270(e) and 1,687 HCT/P establishments (2,109 x 80 percent = 1,687)
maintain an average of 5 complaint records annually (Sec.
1271.320(b)).
FDA estimates that under Sec. 1271.420(a), 200 establishments will
submit 560 reports of HCT/Ps offered for imports.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
21 CFR part 1271; human cells, Number of
tissues, and cellular and Number of responses per Total annual Average burden Total hours
tissue-based products respondents respondent responses per response \3\
----------------------------------------------------------------------------------------------------------------
1271.10(b)(1) and 1271.21(b) 2,736 1 2,736 0.5 (30 minutes) 1,368
\2\.
1271.10(b)(1) and (2), 193 1 193 0.75 (45 145
1271.21(a), and 1271.25(a) minutes).
and (b) \2\.
1271.10(b)(2), 1,062 1 1,062 0.5 (30 minutes) 531
1271.21(c)(2)(ii) and
1271.25(c) \2\.
1271.23....................... 1 1 1 1............... 1
1271.26 \2\................... 358 1 358 0.25 (15 90
minutes).
[[Page 66677]]
1271.155(a)................... 15 4.27 64 3............... 192
1271.350(a)(1) and (3)........ 13 14.46 188 1............... 188
1271.420(a)................... 200 2.8 560 0.25 (15 140
minutes).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 2,655
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Using eHCTERS.
\3\ Rounded to the nearest whole number.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
21 CFR part 1271; human cells, Number of Average burden
tissues, and cellular and Number of records per Total annual per Total hours
tissue-based products recordkeepers recordkeeper records recordkeeping \3\
----------------------------------------------------------------------------------------------------------------
New SOPs \2\.................. 193 1 193 48.............. 9,264
SOP Update \2\................ 2,736 1 2,736 24.............. 65,664
1271.47(d).................... 1,368 1 1,368 1............... 1,368
1271.50(a).................... 2,736 39.846 109,019 5............... 545,095
1271.55(d)(1)................. 2,736 39.846 109,019 1............... 109,019
1271.55(d)(2)................. 2,736 1 2,736 1............... 2,736
1271.55(d)(4)................. 2,736 1 2,736 120............. 328,320
1271.60(d)(3) and (4) 821 1 821 2............... 1,642
1271.65(b)(3)(iii).
1271.155(f)................... 15 4.27 64 0.25 (15 16
minutes).
1271.160(b)(3) and (6)........ 2,109 12 25,308 1............... 25,308
1271.160(d)................... 2,109 12 25,308 1............... 25,308
1271.190(d)(2)................ 2,109 12 25,308 1............... 25,308
1271.195(d)................... 2,109 12 25,308 1............... 25,308
1271.200(e)................... 2,109 12 25,308 1............... 25,308
1271.210(d)................... 2,109 12 25,308 1............... 25,308
1271.230(a)................... 2,109 12 25,308 1............... 25,308
1271.230(c)................... 2,109 1 2,109 1............... 2,109
1271.260(d)................... 2,109 12 25,308 0.25 (15 6,327
minutes).
1271.260(e)................... 2,109 365 769,785 0.083 (5 63,892
minutes).
1271.265(c)(1)................ 2,109 1,163.781 2,454,415 0.083 (5 203,716
minutes).
1271.265(c)(3)................ 1,055 1 1,055 1............... 1,055
1271.265(e)................... 2,109 1,163.781 2,454,415 0.083 (5 203,716
minutes).
1271.270(a)................... 2,109 1,163.781 2,454,415 0.25 (15 613,604
minutes).
1271.270(e)................... 2,189 2 4,378 0.5 (30 minutes) 2,189
1271.290(d) and (e)........... 2,109 49.037 103,419 0.25 (15 25,855
minutes).
1271.320(b)................... 1,687 5 8,435 1............... 8,435
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 2,371,178
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b),
1271.200(c), 1271.230(a), 1271.250(a), and 1271.265(e).
\3\ Rounded to the nearest whole number.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
21 CFR part 1271; human Number of
cells, tissues, and cellular Number of disclosures per Total annual Average burden Total hours
and tissue-based products respondents respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
1271.55(a)................... 1,632 1,589.715 2,594,415 0.5 (30 1,297,208
minutes).
1271.60(c) and (d)(2)........ 1,611 355.06 572,000 0.5 (30 286,000
minutes).
1271.290(c).................. 2,109 1,163.781 2,454,415 0.083 (5 203,716
minutes).
1271.290(f).................. 2,109 1 2,109 1.............. 2,109
1271.370(b) and (c).......... 2,109 1,163.781 2,454,415 0.25 (15 613,604
minutes).
----------------------------------------------------------------------------------
Total.................... .............. ................ .............. ............... 2,402,637
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Rounded to the nearest whole number.
Our estimated burden for the information collection reflects an
overall increase of 628,585 hours (111 reporting burden hours; 305,118
recordkeeping hours; and 323,356 disclosure burden hours) and a
corresponding increase of annual responses, annual records, and annual
disclosures. We attribute this
[[Page 66678]]
adjustment to an increase in the number HCT/P establishments and an
increase in the number HCT/Ps distributed over the past few years.
Dated: November 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26234 Filed 12-4-19; 8:45 am]
BILLING CODE 4164-01-P
