Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice, 16040-16044 [2017-06398]
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sradovich on DSK3GMQ082PROD with NOTICES
16040
Federal Register / Vol. 82, No. 61 / Friday, March 31, 2017 / Notices
Revocable Trust dated October 7, 2008,
James P. Stein Trust Number One, and
the Inter Vivos Stock Trust of Simon G.
Stein IV FBO James P. Stein, Muscatine,
Iowa; James P. Stein as trustee of the
James P. Stein Revocable Trust dated
December 16, 2005 and the Inter Vivos
Stock Trust of Simon G. Stein IV FBO
James P. Stein, Muscatine, Iowa;
Timothy J. Stein as trustee of the
Timothy J. Stein Revocable Trust dated
August 10, 2012, James P. Stein Trust
Number One, and the Inter Vivos Stock
Trust of Simon G. Stein IV FBO James
P. Stein, Lakeway, Texas; Carrie A.
Zorich as trustee of the Carrie A. Zorich
Revocable Trust dated July 23, 2007,
James P. Stein Trust Number One, and
the Inter Vivos Stock Trust of Simon G.
Stein IV FBO James P. Stein, Muscatine,
Iowa; Maryann Bramhall-Lambert as
trustee of the GST Exempt Trust for
benefit of James P. Stein Family, Iowa
City, Iowa; GST Exempt Trust for benefit
of James P. Stein Family, Muscatine,
Iowa; Daniel P. Stein Revocable Trust
dated October 7, 2008, Muscatine, Iowa;
James P. Stein Revocable Trust dated
December 16, 2005, Muscatine, Iowa;
Timothy J. Stein Revocable Trust dated
August 10, 2012, Lakeway, Texas; Carrie
A. Zorich Revocable Trust dated July 23,
2007, Muscatine, Iowa; James P. Stein
Trust Number One, Muscatine, Iowa;
Inter Vivos Stock Trust of Simon G.
Stein IV FBO James P. Stein, Muscatine,
Iowa; Thomas L. Lambert, Iowa City,
Iowa; Francis L. Lambert, Rock Island,
Illinois; and Susan M. Yeast, West
Liberty, Iowa; in addition to, James P.
Stein; Timothy J. Stein; Carrie A. Zorich;
Daniel P. Stein; Benjamin L. Parks, Iowa
City, Iowa; William M. Parks; and Ruth
M. Parks, Muscatine, Iowa, as members
of Sawyer Group Family Council which
votes and controls shares owned by the
Ann F. Parks Special Trust Number
One; GST Exempt Trust for benefit of
James P. Stein Family; Daniel P. Stein
Revocable Trust dated October 7, 2008;
James P. Stein Revocable Trust dated
December 16, 2005; Timothy J. Stein
Revocable Trust dated August 10, 2012;
Carrie A. Zorich Revocable Trust dated
July 23, 2007; James P. Stein Trust
Number One; and the Inter Vivos Stock
Trust of Simon G. Stein IV FBO James
P. Stein, as a group acting in concert; to
retain voting shares of Central
Bancshares, Inc. and thereby indirectly
retain shares of CBI Bank & Trust,
Muscatine, Iowa, and The Farmers and
Mechanics Bank, Galesburg, Illinois.
B. Federal Reserve Bank of St. Louis
(David L. Hubbard, Senior Manager)
P.O. Box 442, St. Louis, Missouri
63166–2034. Comments can also be sent
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electronically to
Comments.applications@stls.frb.org:
1. Craig L. Weiss, Memphis,
Tennessee; to acquire shares of Paragon
Financial Solutions, Inc., and thereby
indirectly acquire shares of Paragon
Bank, both of Memphis, Tennessee.
C. Federal Reserve Bank of Dallas
(Robert L. Triplett III, Senior Vice
President) 2200 North Pearl Street,
Dallas, Texas 75201–2272:
1. Keitha Ann Nilsson, Daingerfield,
Texas, and Mickey Wiley Carter, Jr.,
Omaha, Texas; to join the Holton Family
Group, a group acting in concert; to
retain voting shares of WSB Bancshares,
Inc., and indirectly retain shares of
Wellington State Bank, both of
Wellington, Texas.
Board of Governors of the Federal Reserve
System, March 28, 2017.
Yao-Chin Chao,
Assistant Secretary of the Board.
[FR Doc. 2017–06394 Filed 3–30–17; 8:45 am]
BILLING CODE 6210–01–P
FEDERAL RESERVE SYSTEM
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than April 27, 2017.
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A. Federal Reserve Bank of
Philadelphia (William Spaniel, Senior
Vice President) 100 North 6th Street,
Philadelphia, Pennsylvania 19105–
1521. Comments can also be sent
electronically to
Comments.applications@phil.frb.org:
1. Hamilton Bancorp, Inc., Ephrata,
Pennsylvania; to become a bank holding
company by acquiring Stonebridge
Bank, West Chester, Pennsylvania.
Board of Governors of the Federal Reserve
System, March 28, 2017.
Yao-Chin Chao,
Assistant Secretary of the Board.
[FR Doc. 2017–06395 Filed 3–30–17; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0731]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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 we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by May 1,
2017.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0543. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
For
specific questions for FDA related to
this document, contact JonnaLynn
Capezzuto, Office of Operations, Food
and Drug Administration, Three White
FOR FURTHER INFORMATION CONTACT:
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Federal Register / Vol. 82, No. 61 / Friday, March 31, 2017 / Notices
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–3794.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
sradovich on DSK3GMQ082PROD with NOTICES
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
establishment registration and listing
using Form FDA 3356, eligibility
determination for donors, and Current
Good Tissue Practice (CGTP).
Establishment Registration and Listing;
Form FDA 3356
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 described in § 1271.10(a), or that
perform screening or testing of the cell
or tissue donor to register with FDA
(§ 1271.10(b)(1)) and submit a list of
each HCT/P manufactured
(§ 1271.10(b)(2)). Section 1271.21(a)
requires an establishment to follow
certain procedures for initial registration
and listing of HCT/Ps, and § 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 requires
establishments to submit an amendment
if ownership or location of the
establishment changes. FDA requires
the use of a registration and listing form,
Form FDA 3356: Establishment
Registration and Listing for Human
Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps), to submit the
required information (§§ 1271.10,
1271.21, 1271.25, and 1271.26)). To
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further facilitate the ease and speed of
submissions, electronic submission is
accepted at https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
EstablishmentRegistration/Tissue
EstablishmentRegistration/default.htm.
Form FDA 3356 is being revised as
follows: (1) Adding import contact
information including an email address
and phone number; (2) deleting
columns related to HCT/Ps subject to
registration and listing under 21 CFR
part 207 or 807; and (3) revising the
instructions accordingly. The estimated
burden is not affected by these changes.
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
§ 1271.90. The documented
determination of a donor’s eligibility is
made by a responsible person as defined
in § 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)). Certain records
must accompany an HCT/P once the
donor-eligibility determination has been
made (§ 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). Once the donoreligibility 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 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
donor-eligibility 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
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16041
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 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 a 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
(d)(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
(§ 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)). 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)).
Current Good Tissue Practice
FDA requires HCT/P establishments
to follow CGTP (§ 1271.1(b)). Section
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) 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
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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
(a)(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)
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) (receiving, investigation,
evaluating, and documenting
information relating to core CGTP
requirements, including complaints,
and for sharing information with
consignees and other establishments);
(2) § 1271.180(a) (to meet core CGTP
requirements for all steps performed in
the manufacture of HCT/Ps); (3)
§ 1271.190(d)(1) (facility cleaning and
sanitization); (4) § 1271.200(b) (cleaning,
sanitizing, and maintenance of
equipment); (5) § 1271.200(c)
(calibration of equipment); (6)
§ 1271.230(a) and (c) (validation of a
process and review and evaluation of
changes to a validated process); (7)
§ 1271.250(a) (controls for labeling HCT/
Ps); (8) § 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) (records management
system); (11) § 1271.290(b)(1) (system of
HCT/P tracking); and (12) § 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
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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) 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 § 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)
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
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 this 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
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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) requires
importers of HCT/Ps to notify 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, or perform donor
screening or testing. The estimates
provided 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 2,218 HCT/P
establishments (conventional tissue, eye
tissue, peripheral blood stem cell, stem
cell products from cord blood,
reproductive tissue, and sperm banks),
including 667 manufacturers of HCT/P
products 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
182 new establishments have registered
with FDA (§§ 1271.10(b)(1) and (b)(2)
and 1271.25(a) and (b)). There are an
estimated 1,221 listing updates
(§§ 1271.10(b)(2), 1271.21(c)(ii), and
1271.25(c)) and 588 location/ownership
amendments (§ 1271.26).
Under § 1271.55(a), an estimated total
of 2,206,890 HCT/Ps (which include
conventional tissues, eye tissues,
hematopoetic stem cells/progenitor
cells, and reproductive cells and
tissues), and an estimated total of
2,066,890 non-reproductive cells and
tissues (total HCT/Ps minus
reproductive cells and tissues) are
distributed per year by an estimated
1,551 establishments (2,218 ¥ 667 =
1,551) with approved applications).
Under § 1271.60(c) and (d)(2), FDA
estimates that 1,375 establishments
shipped an estimated 572,000 HCT/P
under quarantine, and that an estimated
25 establishments requested 78
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 1,561 nonreproductive HCT/P establishments
label each of their 2,066,890 HCT/Ps
with certain information. These
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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 34 HCT/P
establishments submitted 166 adverse
reaction reports with 136 involving a
communicable disease
(§ 1271.350(a)(1)).
FDA estimates that 182 new
establishments will create SOPs, and
that 2,218 establishments will review
and revise existing SOPs annually.
FDA estimates that 1,109 HCT/P
establishments (2,218 × 50 percent =
1,109) and 781 non-reproductive HCT/
P establishments (1,561 × 50 percent =
781) 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 665 HCT/P
establishments (2,218 × 30 percent =
665) 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 1,774 HCT/P
establishments (2,218 × 80 percent =
1,774) have to maintain records for an
average of 2 contract establishments to
perform their manufacturing process
(§ 1271.270(e) and 1,249 HCT/P
establishments (1,561 × 80 percent =
1,249)) maintain an average of 5
16043
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. In
some cases, the estimated burden may
appear to be lower or higher than the
burden experienced by individual
establishments. The estimated burden in
these charts is an estimated average
burden, taking into account the range of
impact each regulation may have on
respondents.
In the Federal Register of September
7, 2016 (81 FR 61685), we published a
60-day notice requesting public
comment on the proposed extension of
this collection of information. One
comment was received beyond the
scope of the four information collection
topics solicited and therefore we have
not discussed it in this document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours 3
1271.10(b)(1) and 1271.21(b) 2 ...............................
1271.10(b)(1) and (b)(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 ....
1271.26 2 ..................................................................
1271.155(a) ..............................................................
1271.350(a)(1) and (a)(3) ........................................
1271.420(a) ..............................................................
2,218
182
1
1
2,218
182
.5 (30 minutes) ..........
.75 (45 minutes) ........
1,109
137
1,221
588
25
34
200
1
1
3.12
4.88
2.8
1,221
588
78
166
560
.5 (30 minutes) ..........
.25 (15 minutes) ........
3 ................................
1 ................................
.25 (15 minutes) ........
611
147
234
166
140
Total ..................................................................
........................
........................
........................
....................................
2,544
1 There
2 Using
are no capital costs or operating and maintenance costs associated with this collection of information.
Form FDA 3356.
to the nearest whole number.
3 Rounded
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
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21 CFR section
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 (d)(4) 1271.65(b)(3)(iii) ..............
1271.155(f) ...............................................................
1271.160(b)(3) and (b)(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) ..........................................................
VerDate Sep<11>2014
16:31 Mar 30, 2017
Jkt 241001
PO 00000
Number of
records per
recordkeeper
182
2,218
1,109
2,218
2,218
2,218
2,218
665
25
1,561
1,561
1,561
1,561
1,561
1,561
1,561
1,561
1,561
1,561
1,561
781
Frm 00025
Fmt 4703
1
1
1
49.15
49.15
1
1
1
3.12
12
12
12
12
12
12
12
1
12
365
1,324.08
1
Sfmt 4703
Total annual
records
182
2,218
1,109
109,019
109,019
2,218
2,218
665
78
18,732
18,732
18,732
18,732
18,732
18,732
18,732
1,561
18,732
569,765
2,066,890
781
E:\FR\FM\31MRN1.SGM
Average burden per
recordkeeping
48 ..............................
24 ..............................
1 ................................
5 ................................
1 ................................
1 ................................
120 ............................
2 ................................
.25 (15 minutes) ........
1 ................................
1 ................................
1 ................................
1 ................................
1 ................................
1 ................................
1 ................................
1 ................................
.25 (15 minutes) ........
.083 (5 minutes) ........
.083 (5 minutes) ........
1 ................................
31MRN1
Total hours 3
8,736
53,232
1,109
545,095
109,019
2,218
266,160
1,330
20
18,732
18,732
18,732
18,732
18,732
18,732
18,732
1,561
4,683
47,291
171,552
781
16044
Federal Register / Vol. 82, No. 61 / Friday, March 31, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR section
1271.265(e)
1271.270(a)
1271.270(e)
1271.290(d)
1271.320(b)
Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours 3
..............................................................
..............................................................
..............................................................
and (e) .................................................
..............................................................
1,561
1,561
1,774
1,561
1,249
1,324.08
1,324.08
2
66.25
5
2,066,890
2,066,890
3,548
103,419
6,245
.083 (5 minutes) ........
.25 (15 minutes) ........
.5 (30 minutes) ..........
.25 (15 minutes) ........
1 ................................
171,552
516,723
1,774
25,855
6,245
Total ..................................................................
........................
........................
........................
....................................
2,066,060
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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), 1271.265(e), 1271.265(f), 1271.270(b) and (d), 1271.290(b)(1), and 1271.320(a).
3 Rounded to the nearest whole number.
2 Sections
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section
Number of
disclosures
per respondent
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) .................................................
1,551
1,375
1,561
1,561
1,561
1,422.88
416
1,324.08
1
1,324.08
2,206,890
572,000
2,066,890
1,561
2,066,890
.5 (30 minutes) ..........
.5 (30 minutes) ..........
.083 (5 minutes) ........
1 ................................
.25 (15 minutes) ........
1,103,445
286,000
171,552
1,561
516,723
Total ..................................................................
........................
........................
........................
....................................
2,079,281
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–06398 Filed 3–30–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0001]
Roadmap for Engaging With the Food
and Drug Administration’s Center for
Drug Evaluation and Research; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration’s (FDA’s) Center for
Drug Evaluation and Research (CDER),
is announcing the following public
workshop entitled ‘‘Roadmap for
Engaging with FDA’s Center for Drug
Evaluation and Research (CDER).’’ The
purpose of this workshop is to help the
public learn how to successfully engage
with CDER.
DATES: The public workshop will be
held on May 12, 2017, from 9 a.m. to 3
p.m.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:31 Mar 30, 2017
Jkt 241001
The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20903–0002.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Chris Melton, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–7381, NAVCDER@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a public
workshop entitled ‘‘Roadmap for
Engaging with FDA’s Center for Drug
Evaluation and Research (CDER).’’ This
workshop is intended to help the public
learn the most effective ways to
successfully engage with CDER. There
will be presentations on learning about
the drug approval process, as well as the
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
opportunity for questions and answers
following each presentation.
II. Participating in the Public Workshop
Registration: Persons interested in
attending this workshop must register
online at https://www.eventbrite.com/e/
fda-public-workshop-roadmap-forengaging-with-fdas-center-for-drugevaluation-and-research-cder-tickets28608664285?utm_source=eb_
email&utm_medium=email&utm_
campaign=new_event_email&utm_
term=viewmyevent_button. Please
provide complete contact information
for each attendee, including name, title,
affiliation, address, email and
telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by May 5, 2016, 6 p.m. EST.
Early registration is recommended
because seating is limited; therefore,
FDA may limit the number of
participants from each organization. If
time and space permit, onsite
registration on the day of the public
workshop will be provided beginning at
8 a.m. We will let registrants know if
registration closes before the day of the
public workshop.
If you need special accommodations
due to a disability, please contact Chris
Melton no later than May 1, 2017.
E:\FR\FM\31MRN1.SGM
31MRN1
]]>Agencies
[Federal Register Volume 82, Number 61 (Friday, March 31, 2017)]
[Notices]
[Pages 16040-16044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06398]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0731]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by May 1,
2017.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0543.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: For specific questions for FDA related
to this document, contact JonnaLynn Capezzuto, Office of Operations,
Food and Drug Administration, Three White
[[Page 16041]]
Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-
796-3794.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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
establishment registration and listing using Form FDA 3356, eligibility
determination for donors, and Current Good Tissue Practice (CGTP).
Establishment Registration and Listing; Form FDA 3356
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 described in Sec. 1271.10(a), or that
perform screening or testing of the cell or tissue donor to register
with FDA (Sec. 1271.10(b)(1)) and submit a list of each HCT/P
manufactured (Sec. 1271.10(b)(2)). Section 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) 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 requires establishments to submit an
amendment if ownership or location of the establishment changes. FDA
requires the use of a registration and listing form, Form FDA 3356:
Establishment Registration and Listing for Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps), to submit the required
information (Sec. Sec. 1271.10, 1271.21, 1271.25, and 1271.26)). To
further facilitate the ease and speed of submissions, electronic
submission is accepted at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/TissueEstablishmentRegistration/default.htm.
Form FDA 3356 is being revised as follows: (1) Adding import
contact information including an email address and phone number; (2)
deleting columns related to HCT/Ps subject to registration and listing
under 21 CFR part 207 or 807; and (3) revising the instructions
accordingly. The estimated burden is not affected by these changes.
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 Sec. 1271.90. The documented determination of
a donor's eligibility is made by a responsible person as defined in
Sec. 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)). Certain records must
accompany an HCT/P once the donor-eligibility determination has been
made (Sec. 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. 1271.60). 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 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 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 a 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 (d)(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)), 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)). 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)).
Current Good Tissue Practice
FDA requires HCT/P establishments to follow CGTP (Sec. 1271.1(b)).
Section 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) 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
[[Page 16042]]
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 (a)(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) 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) (receiving,
investigation, 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) (to
meet core CGTP requirements for all steps performed in the manufacture
of HCT/Ps); (3) Sec. 1271.190(d)(1) (facility cleaning and
sanitization); (4) Sec. 1271.200(b) (cleaning, sanitizing, and
maintenance of equipment); (5) Sec. 1271.200(c) (calibration of
equipment); (6) Sec. 1271.230(a) and (c) (validation of a process and
review and evaluation of changes to a validated process); (7) Sec.
1271.250(a) (controls for labeling HCT/Ps); (8) Sec. 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) (records management
system); (11) Sec. 1271.290(b)(1) (system of HCT/P tracking); and (12)
Sec. 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) 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 Sec. 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) 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
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 this
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) requires importers of HCT/Ps to notify 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, or
perform donor screening or testing. The estimates provided 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 2,218 HCT/P establishments (conventional
tissue, eye tissue, peripheral blood stem cell, stem cell products from
cord blood, reproductive tissue, and sperm banks), including 667
manufacturers of HCT/P products 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 182
new establishments have registered with FDA (Sec. Sec. 1271.10(b)(1)
and (b)(2) and 1271.25(a) and (b)). There are an estimated 1,221
listing updates (Sec. Sec. 1271.10(b)(2), 1271.21(c)(ii), and
1271.25(c)) and 588 location/ownership amendments (Sec. 1271.26).
Under Sec. 1271.55(a), an estimated total of 2,206,890 HCT/Ps
(which include conventional tissues, eye tissues, hematopoetic stem
cells/progenitor cells, and reproductive cells and tissues), and an
estimated total of 2,066,890 non-reproductive cells and tissues (total
HCT/Ps minus reproductive cells and tissues) are distributed per year
by an estimated 1,551 establishments (2,218 - 667 = 1,551) with
approved applications).
Under Sec. 1271.60(c) and (d)(2), FDA estimates that 1,375
establishments shipped an estimated 572,000 HCT/P under quarantine, and
that an estimated 25 establishments requested 78 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
1,561 non-reproductive HCT/P establishments label each of their
2,066,890 HCT/Ps with certain information. These
[[Page 16043]]
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 34 HCT/P establishments submitted 166 adverse
reaction reports with 136 involving a communicable disease (Sec.
1271.350(a)(1)).
FDA estimates that 182 new establishments will create SOPs, and
that 2,218 establishments will review and revise existing SOPs
annually.
FDA estimates that 1,109 HCT/P establishments (2,218 x 50 percent =
1,109) and 781 non-reproductive HCT/P establishments (1,561 x 50
percent = 781) 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 665 HCT/P establishments (2,218 x 30 percent =
665) 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 1,774 HCT/P establishments (2,218 x 80
percent = 1,774) have to maintain records for an average of 2 contract
establishments to perform their manufacturing process (Sec.
1271.270(e) and 1,249 HCT/P establishments (1,561 x 80 percent =
1,249)) maintain an average of 5 complaint records annually (Sec.
1271.320(b)).
FDA estimates that under 1271.420(a), 200 establishments will
submit 560 reports of HCT/Ps offered for imports. In some cases, the
estimated burden may appear to be lower or higher than the burden
experienced by individual establishments. The estimated burden in these
charts is an estimated average burden, taking into account the range of
impact each regulation may have on respondents.
In the Federal Register of September 7, 2016 (81 FR 61685), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. One comment was received
beyond the scope of the four information collection topics solicited
and therefore we have not discussed it in this document.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.10(b)(1) and 1271.21(b) \2\............ 2,218 1 2,218 .5 (30 minutes)........................... 1,109
1271.10(b)(1) and (b)(2), 1271.21(a), and 182 1 182 .75 (45 minutes).......................... 137
1271.25(a) and (b) \2\.
1271.10(b)(2), 1271.21(c)(2)(ii) and 1,221 1 1,221 .5 (30 minutes)........................... 611
1271.25(c) \2\.
1271.26 \2\................................. 588 1 588 .25 (15 minutes).......................... 147
1271.155(a)................................. 25 3.12 78 3......................................... 234
1271.350(a)(1) and (a)(3)................... 34 4.88 166 1......................................... 166
1271.420(a)................................. 200 2.8 560 .25 (15 minutes).......................... 140
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total................................... .............. .............. .............. .......................................... 2,544
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Using Form FDA 3356.
\3\ Rounded to the nearest whole number.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
New SOPs \2\................................ 182 1 182 48........................................ 8,736
SOP Update \2\.............................. 2,218 1 2,218 24........................................ 53,232
1271.47(d).................................. 1,109 1 1,109 1......................................... 1,109
1271.50(a).................................. 2,218 49.15 109,019 5......................................... 545,095
1271.55(d)(1)............................... 2,218 49.15 109,019 1......................................... 109,019
1271.55(d)(2)............................... 2,218 1 2,218 1......................................... 2,218
1271.55(d)(4)............................... 2,218 1 2,218 120....................................... 266,160
1271.60(d)(3) and (d)(4) 1271.65(b)(3)(iii). 665 1 665 2......................................... 1,330
1271.155(f)................................. 25 3.12 78 .25 (15 minutes).......................... 20
1271.160(b)(3) and (b)(6)................... 1,561 12 18,732 1......................................... 18,732
1271.160(d)................................. 1,561 12 18,732 1......................................... 18,732
1271.190(d)(2).............................. 1,561 12 18,732 1......................................... 18,732
1271.195(d)................................. 1,561 12 18,732 1......................................... 18,732
1271.200(e)................................. 1,561 12 18,732 1......................................... 18,732
1271.210(d)................................. 1,561 12 18,732 1......................................... 18,732
1271.230(a)................................. 1,561 12 18,732 1......................................... 18,732
1271.230(c)................................. 1,561 1 1,561 1......................................... 1,561
1271.260(d)................................. 1,561 12 18,732 .25 (15 minutes).......................... 4,683
1271.260(e)................................. 1,561 365 569,765 .083 (5 minutes).......................... 47,291
1271.265(c)(1).............................. 1,561 1,324.08 2,066,890 .083 (5 minutes).......................... 171,552
1271.265(c)(3).............................. 781 1 781 1......................................... 781
[[Page 16044]]
1271.265(e)................................. 1,561 1,324.08 2,066,890 .083 (5 minutes).......................... 171,552
1271.270(a)................................. 1,561 1,324.08 2,066,890 .25 (15 minutes).......................... 516,723
1271.270(e)................................. 1,774 2 3,548 .5 (30 minutes)........................... 1,774
1271.290(d) and (e)......................... 1,561 66.25 103,419 .25 (15 minutes).......................... 25,855
1271.320(b)................................. 1,249 5 6,245 1......................................... 6,245
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total................................... .............. .............. .............. .......................................... 2,066,060
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\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),
1271.265(e), 1271.265(f), 1271.270(b) and (d), 1271.290(b)(1), and 1271.320(a).
\3\ Rounded to the nearest whole number.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.55(a).................................. 1,551 1,422.88 2,206,890 .5 (30 minutes)........................... 1,103,445
1271.60(c) and (d)(2)....................... 1,375 416 572,000 .5 (30 minutes)........................... 286,000
1271.290(c)................................. 1,561 1,324.08 2,066,890 .083 (5 minutes).......................... 171,552
1271.290(f)................................. 1,561 1 1,561 1......................................... 1,561
1271.370(b) and (c)......................... 1,561 1,324.08 2,066,890 .25 (15 minutes).......................... 516,723
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total................................... .............. .............. .............. .......................................... 2,079,281
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-06398 Filed 3-30-17; 8:45 am]
BILLING CODE 4164-01-P
