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; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice, 3822-3825 [2014-01223]
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3822
ACTION:
Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Biologics License Application,
Changes to an Approved Application,
Labeling, Revocation and Suspension,
Postmarketing Studies Status Reports,
and Forms FDA 356h and 2567’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
November 13, 2013, the Agency
submitted a proposed collection of
information entitled ‘‘Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension, Postmarketing Studies
Status Reports, and Forms FDA 356h
and 2567’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0338. The
approval expires on January 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUMMARY:
Dated: January 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–01233 Filed 1–22–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sroberts on DSK5SPTVN1PROD with NOTICES
[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; Form FDA
3356; Eligibility Determination for
Donors; and Current Good Tissue
Practice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Mar<15>2010
21:50 Jan 22, 2014
The Food and Drug
Administration (FDA) 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 February
24, 2014.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
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.
SUMMARY:
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Human Cells, Tissues, and Cellular and
Tissue-Based Products: Establishment
Registration and Listing; Form FDA
3356; 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 Human Cells,
Tissues, and Cellular and Tissue-Based
Products (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
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Fmt 4703
Sfmt 4703
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
further facilitate the ease and speed of
submissions, electronic submission is
accepted at (https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
EstablishmentRegistration/
TissueEstablishmentRegistration/
default.htm).
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,
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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
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 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 an 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,
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Jkt 232001
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 (CGTP)
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
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
(SOPs) provisions under part 1271
include the following: (1) Section
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) (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) and (d) (records
management system); (11)
§ 1271.290(b)(1) (system of HCT/P
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3823
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
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
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Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
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.
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 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 2,706 HCT/P
establishments (conventional tissue, eye
tissue, peripheral blood stem cell, stem
cell products from cord blood,
reproductive tissue, and sperm banks),
including 741 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
218 new establishments have registered
with FDA (§§ 1271.10(b)(1) and (b)(2)
and 1271.25(a) and (b)). There are an
estimated 3,737 listing updates
(§§ 1271.10(b)(2), 1271.21(c)(ii), and
1271.25(c)) and 1,222 location/
ownership amendments (§ 1271.26).
Under § 1271.55(a), an estimated total
of 2,167, 396 HCT/Ps (which include
conventional tissues, eye tissues,
hematopoetic stem cells/progenitor
cells, and reproductive cells and
tissues), and an estimated total of
2,026,861 non-reproductive cells and
tissues (total HCT/Ps minus
reproductive cells and tissues) are
distributed per year by an estimated
1,965 establishments (2,706¥741 =
1,965) with approved applications.
Under § 1271.60(c) and (d)(2), FDA
estimates that 1,375 establishments
shipped an estimated 286,000 HCT/Ps
under quarantine, and that an estimated
26 establishments requested 40
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 1,694 nonreproductive HCT/P establishments
label each of their 2,026,861 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 24 HCT/P
establishments submitted 206 adverse
reaction reports with 167 involving a
communicable disease
(§ 1271.350(a)(1)).
FDA estimates that 218 new
establishments will create SOPs, and
that 2,706 establishments will review
and revise existing SOPs annually.
FDA estimates that 1,353 HCT/P
establishments (2,706 × 50 percent =
1,353) and 847 non-reproductive HCT/
P establishments (1,694 × 50 percent =
847) 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 91,756
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
86,156 non-reproductive cells and tissue
donors (total donors minus reproductive
cell and tissue donors).
FDA estimates that 812 HCT/P
establishments (2,706 × 30 percent =
812) 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 2,165 HCT/P
establishments (2,706 × 80 percent =
2,165) have to maintain records for an
average of 2 contract establishments to
perform their manufacturing process
(§ 1271.270(e) and 1,353 HCT/P
establishments maintain an average of 5
complaint records annually
(§ 1271.320(b)).
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.
In the Federal Register of July 12,
2013 (78 FR 41934), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
sroberts on DSK5SPTVN1PROD with NOTICES
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
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)(ii), and 1271.25(c) 2 .....
1271.26 2 ................................................................
1271.155(a) ............................................................
1271.350(a)(1) and (a)(3) ......................................
2,706
218
1
1
2,706
218
.5 (30 minutes) ..........
.75 (45 minutes) ........
1,353
164
3,737
1,222
26
24
1
1
1.54
8.58
3,737
1,222
40
206
.5 (30 minutes) ..........
.25 (15 minutes) ........
3 ................................
1 ................................
1,869
306
120
206
Total ................................................................
........................
..........................
........................
....................................
4,018
1 There
2 Using
are no capital costs or operating and maintenance costs associated with this collection of information.
Form FDA 3356.
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3825
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
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) .................
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) ........................................................
1271.265(e) ............................................................
1271.270(a) ............................................................
1271.270(e) ............................................................
1271.290(d) and (e) ...............................................
1271.320(b) ............................................................
218
2,706
1,353
2,706
2,706
2,706
2,706
812
26
1,694
1,694
1,694
1,694
1,694
1,694
1,694
1,694
1,694
1,694
1,694
847
1,694
1,694
2,165
1,694
1,353
1
1
1
33.91
33.91
1
1
1
1.54
12
12
12
12
12
12
12
1
12
365
1,196.49
1
1,196.49
1,196.49
2
50.86
5
218
2,706
1,353
91,756
91,756
2,706
2,706
812
40
20,328
20,328
20,328
20,328
20,328
20,328
20,328
1,694
20,328
618,310
2,026,861
847
2,026,861
2,026,861
4,330
86,156
6,765
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 ................................
.083 (5 minutes) ........
.25 (15 minutes) ........
.5 (30 minutes) ..........
.25 (15 minutes) ........
1 ................................
10,464
64,944
1,353
458,780
91,756
2,706
324,720
1,624
10
20,328
20,328
20,328
20,328
20,328
20,328
20,328
1,694
5,082
51,320
168,229
847
168,229
506,715
2,165
21,539
6,765
Total ................................................................
........................
..........................
........................
....................................
2,031,238
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) and (c),
1271.250(a), 1271.265(e) and (f), 1271.270(b) and (d), 1271.290(b)(1), and 1271.320(a).
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) ...............................................
1,965
1,375
1,694
1,694
1,694
1,103
208
1,196.49
1
1,196.49
2,167,396
286,000
2,026,861
1,694
2,026,861
.5 (30 minutes) ..........
.5 (30 minutes) ..........
.083 (5 minutes) ........
1 ................................
.25 (15 minutes) ........
1,083,698
143,000
168,229
1,694
506,715
Total ................................................................
........................
..........................
........................
....................................
1,903,336
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–01223 Filed 1–22–14; 8:45 am]
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[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3822-3825]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01223]
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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; Form FDA 3356; Eligibility Determination for Donors; and
Current Good Tissue Practice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
February 24, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.
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; Form FDA 3356; 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 Human Cells,
Tissues, and Cellular and Tissue-Based Products (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).
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,
[[Page 3823]]
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 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 an
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 (CGTP)
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 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 (SOPs) provisions under part 1271
include the following: (1) Section 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) (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) and (d) (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 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) 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
[[Page 3824]]
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.
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 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 2,706 HCT/P establishments (conventional
tissue, eye tissue, peripheral blood stem cell, stem cell products from
cord blood, reproductive tissue, and sperm banks), including 741
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 218
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 3,737
listing updates (Sec. Sec. 1271.10(b)(2), 1271.21(c)(ii), and
1271.25(c)) and 1,222 location/ownership amendments (Sec. 1271.26).
Under Sec. 1271.55(a), an estimated total of 2,167, 396 HCT/Ps
(which include conventional tissues, eye tissues, hematopoetic stem
cells/progenitor cells, and reproductive cells and tissues), and an
estimated total of 2,026,861 non-reproductive cells and tissues (total
HCT/Ps minus reproductive cells and tissues) are distributed per year
by an estimated 1,965 establishments (2,706-741 = 1,965) with approved
applications.
Under Sec. 1271.60(c) and (d)(2), FDA estimates that 1,375
establishments shipped an estimated 286,000 HCT/Ps under quarantine,
and that an estimated 26 establishments requested 40 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
1,694 non-reproductive HCT/P establishments label each of their
2,026,861 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 24 HCT/P establishments submitted 206 adverse
reaction reports with 167 involving a communicable disease (Sec.
1271.350(a)(1)).
FDA estimates that 218 new establishments will create SOPs, and
that 2,706 establishments will review and revise existing SOPs
annually.
FDA estimates that 1,353 HCT/P establishments (2,706 x 50 percent =
1,353) and 847 non-reproductive HCT/P establishments (1,694 x 50
percent = 847) 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 91,756 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 86,156 non-reproductive cells and tissue donors
(total donors minus reproductive cell and tissue donors).
FDA estimates that 812 HCT/P establishments (2,706 x 30 percent =
812) 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 2,165 HCT/P establishments (2,706 x 80
percent = 2,165) have to maintain records for an average of 2 contract
establishments to perform their manufacturing process (Sec.
1271.270(e) and 1,353 HCT/P establishments maintain an average of 5
complaint records annually (Sec. 1271.320(b)).
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.
In the Federal Register of July 12, 2013 (78 FR 41934), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.10(b)(1) and 1271.21(b) \2\............ 2,706 1 2,706 .5 (30 minutes)........................... 1,353
1271.10(b)(1) and (b)(2), 1271.21(a), and 218 1 218 .75 (45 minutes).......................... 164
1271.25(a) and (b) \2\.
1271.10(b)(2), 1271.21(c)(ii), and 3,737 1 3,737 .5 (30 minutes)........................... 1,869
1271.25(c) \2\.
1271.26 \2\................................. 1,222 1 1,222 .25 (15 minutes).......................... 306
1271.155(a)................................. 26 1.54 40 3......................................... 120
1271.350(a)(1) and (a)(3)................... 24 8.58 206 1......................................... 206
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 4,018
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Using Form FDA 3356.
[[Page 3825]]
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
New SOPs \2\................................ 218 1 218 48........................................ 10,464
SOP Update \2\.............................. 2,706 1 2,706 24........................................ 64,944
1271.47(d).................................. 1,353 1 1,353 1......................................... 1,353
1271.50(a).................................. 2,706 33.91 91,756 5......................................... 458,780
1271.55(d)(1)............................... 2,706 33.91 91,756 1......................................... 91,756
1271.55(d)(2)............................... 2,706 1 2,706 1......................................... 2,706
1271.55(d)(4)............................... 2,706 1 2,706 120....................................... 324,720
1271.60(d)(3) and (d)(4) 1271.65(b)(3)...... 812 1 812 2......................................... 1,624
1271.155(f)................................. 26 1.54 40 .25 (15 minutes).......................... 10
1271.160(b)(3) and (b)(6)................... 1,694 12 20,328 1......................................... 20,328
1271.160(d)................................. 1,694 12 20,328 1......................................... 20,328
1271.190(d)(2).............................. 1,694 12 20,328 1......................................... 20,328
1271.195(d)................................. 1,694 12 20,328 1......................................... 20,328
1271.200(e)................................. 1,694 12 20,328 1......................................... 20,328
1271.210(d)................................. 1,694 12 20,328 1......................................... 20,328
1271.230(a)................................. 1,694 12 20,328 1......................................... 20,328
1271.230(c)................................. 1,694 1 1,694 1......................................... 1,694
1271.260(d)................................. 1,694 12 20,328 .25 (15 minutes).......................... 5,082
1271.260(e)................................. 1,694 365 618,310 .083 (5 minutes).......................... 51,320
1271.265(c)(1).............................. 1,694 1,196.49 2,026,861 .083 (5 minutes).......................... 168,229
1271.265(c)(3).............................. 847 1 847 1......................................... 847
1271.265(e)................................. 1,694 1,196.49 2,026,861 .083 (5 minutes).......................... 168,229
1271.270(a)................................. 1,694 1,196.49 2,026,861 .25 (15 minutes).......................... 506,715
1271.270(e)................................. 2,165 2 4,330 .5 (30 minutes)........................... 2,165
1271.290(d) and (e)......................... 1,694 50.86 86,156 .25 (15 minutes).......................... 21,539
1271.320(b)................................. 1,353 5 6,765 1......................................... 6,765
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 2,031,238
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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) and (c),
1271.250(a), 1271.265(e) and (f), 1271.270(b) and (d), 1271.290(b)(1), and 1271.320(a).
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual
21 CFR section respondents per Disclosures Average burden per disclosure Total hours
respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.55(a).................................. 1,965 1,103 2,167,396 .5 (30 minutes)........................... 1,083,698
1271.60(c) and (d)(2)....................... 1,375 208 286,000 .5 (30 minutes)........................... 143,000
1271.290(c)................................. 1,694 1,196.49 2,026,861 .083 (5 minutes).......................... 168,229
1271.290(f)................................. 1,694 1 1,694 1......................................... 1,694
1271.370(b) and (c)......................... 1,694 1,196.49 2,026,861 .25 (15 minutes).......................... 506,715
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 1,903,336
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01223 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P
