Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice, 61685-61690 [2016-21351]
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Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices
Elaine L. Baker, MPH, DLP,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention (CDC).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 0910–0607. Also
include the FDA docket number found
in brackets in the heading of this
document.
Food and Drug Administration
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2016–21400 Filed 9–6–16; 8:45 am]
BILLING CODE 4163–18–P
[Docket No. FDA–2013–N–0514]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Requests for
Clinical Laboratory Improvement
Amendments Categorization
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 October 7,
2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 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.
Requests for Clinical Laboratory
Improvement Amendments of 1988
Categorization—42 CFR 493.17—OMB
Control Number 0910–0607—Extension
A guidance document entitled
‘‘Guidance for Administrative
Procedures for CLIA Categorization’’
was released on May 7, 2008. The
document describes procedures FDA
uses to assign the complexity category
to a device. Typically, FDA assigns
complexity categorizations to devices at
the time of clearance or approval of the
device. In this way, no additional
burden is incurred by the manufacturer
because the labeling (including
operating instructions) is included in
the premarket notification (510(k)) or
premarket approval application (PMA).
In some cases, however, a manufacturer
may request Clinical Laboratory
Improvement Amendments of 1998
(CLIA) categorization even if FDA is not
simultaneously reviewing a 510(k) or
PMA. One example is when a
manufacturer requests that FDA assign
CLIA categorization to a previously
cleared device that has changed names
since the original CLIA categorization.
Another example is when a device is
exempt from premarket review. In such
cases, the guidance recommends that
manufacturers provide FDA with a copy
of the package insert for the device and
a cover letter indicating why the
manufacturer is requesting a
categorization (e.g. name change,
exempt from 510(k) review). The
guidance recommends that in the
correspondence to FDA the
manufacturer should identify the
product code and classification as well
as reference to the original 510(k) when
this is available.
In the Federal Register of April 27,
2016 (81 FR 24820), 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
Activity
Request for CLIA Categorization .............
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1
Number of
responses per
respondent
60
Total annual
responses
15
Average
burden per
response
900
Total hours
1
Total operating
and
maintenance
costs
900
$46,800
There are no capital costs associated with this collection of information.
The number of respondents is
approximately 60. On average, each
respondent will request categorizations
(independent of a 510(k) or PMA) 15
times per year. The cost, not including
personnel, is estimated at $52 per hour
(52 × 900), totaling $46,800. This
includes the cost of copying and mailing
copies of package inserts and a cover
letter, which includes a statement of the
reason for the request and reference to
the original 510(k) numbers, including
regulation numbers and product codes.
The burden hours are based on FDA
familiarity with the types of
documentation typically included in a
sponsor’s categorization requests, and
costs for basic office supplies (e.g.,
paper).
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Dated: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21352 Filed 9–6–16; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0731]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Human Cells,
Tissues, and Cellular and TissueBased Products: Establishment
Registration and Listing; Eligibility
Determination for Donors; and Current
Good Tissue Practice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection requirements
for FDA regulations related to human
cells, tissues, and cellular and tissuebased products (HCT/Ps) involving
establishment registration and listing
using Form FDA 3356; eligibility
determination for donors; and current
good tissue practice (CGTP).
DATES: Submit either written or
electronic comments on the collection
of information by November 7, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
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Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
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• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–N–0731 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Human
Cells, Tissues, and Cellular and TissueBased Products: Establishment
Registration and Listing; Eligibility
Determination for Donors; and Current
Good Tissue Practice.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
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‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 11601 Landsdown St., 10A–
12M, North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Human Cells, Tissues, and Cellular and
Tissue-Based Products: Establishment
Registration and Listing; Eligibility
Determination for Donors; and Current
Good Tissue Practice—OMB Control
Number 0910–0543—Extension
Under section 361 of the Public
Health Service Act (the PHS Act) (42
U.S.C. 264), FDA may issue and enforce
regulations necessary to prevent the
introduction, transmission, or spread of
communicable diseases between the
States or possessions or from foreign
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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 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
further facilitate the ease and speed of
submissions, electronic submission is
accepted at https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/
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 § 1271.1(b)
to determine donor eligibility based on
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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
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
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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 (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.
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Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices
The standard operating procedures
(SOP) provisions under part 1271
include the following: (1)
§ 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
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
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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.
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.
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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
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
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Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices
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
61689
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.
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) ........................................
2,218
182
1
1
2,218
182
.5 (30 minutes) ..........
.75 (45 minutes) ........
1,109
137
1,221
588
25
34
1
1
3.12
4.88
1,221
588
78
166
.5 (30 minutes) ..........
.25 (15 minutes) ........
3 ................................
1 ................................
611
147
234
166
Total ..................................................................
........................
........................
........................
....................................
2,404
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Form FDA 3356.
3 Rounded to the nearest whole number.
2 Using
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
record-keepers
mstockstill on DSK3G9T082PROD with NOTICES
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours 3
New SOPs 2 .............................................................
SOP Update 2 ...........................................................
1271.47(d) ................................................................
1271.50(a) ................................................................
1271.55(d)(1) ...........................................................
1271.55(d)(2) ...........................................................
1271.55(d)(4) ...........................................................
1271.60(d)(3) and (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) ..........................................................
1271.265(e) ..............................................................
1271.270(a) ..............................................................
1271.270(e) ..............................................................
1271.290(d) and (e) .................................................
1271.320(b) ..............................................................
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
1,561
1,561
1,774
1,561
1,249
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
1,324.08
1,324.08
2
66.25
5
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
2,066,890
2,066,890
3,548
103,419
6,245
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 ................................
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
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), and 1271.265(e).
3 Rounded to the nearest whole number.
2 Sections
VerDate Sep<11>2014
17:30 Sep 06, 2016
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61690
Federal Register / Vol. 81, No. 173 / Wednesday, September 7, 2016 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
disclosures
per
respondent
Number of
respondents
21 CFR Section
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: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
FD&C Act. The Authorization, which
includes an explanation of the reasons
for issuance, is reprinted in this
document.
[FR Doc. 2016–21351 Filed 9–6–16; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1486]
Authorization of Emergency Use of an
In Vitro Diagnostic Device for
Detection of Zika Virus; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
for an in vitro diagnostic device for
detection of the Zika virus in response
to the Zika virus outbreak in the
Americas. FDA issued this
Authorization under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
as requested by Viracor-IBT
Laboratories, Inc. The Authorization
contains, among other things,
conditions on the emergency use of the
authorized in vitro diagnostic device.
The Authorization follows the February
26, 2016, determination by the Secretary
of Health and Human Services (HHS)
that there is a significant potential for a
public health emergency that has a
significant potential to affect national
security or the health and security of
U.S. citizens living abroad and that
involves Zika virus. On the basis of such
determination, the Secretary of HHS
declared on February 26, 2016, that
circumstances exist justifying the
authorization of emergency use of in
vitro diagnostic tests for detection of
Zika virus and/or diagnosis of Zika
virus infection, subject to the terms of
any authorization issued under the
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:30 Sep 06, 2016
The Authorization is effective as
of July 19, 2016.
ADDRESSES: Submit written requests for
single copies of the EUA to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
Rm. 4338, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a fax number to
which the Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
DATES:
BILLING CODE 4164–01–P
Jkt 238001
FOR FURTHER INFORMATION CONTACT:
Carmen Maher, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4347, Silver Spring, MD 20993–0002,
301–796–8510 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276) and the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
nuclear, and radiological agents. Among
other things, section 564 of the FD&C
Act allows FDA to authorize the use of
an unapproved medical product or an
unapproved use of an approved medical
product in certain situations. With this
EUA authority, FDA can help assure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents when there are no
PO 00000
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adequate, approved, and available
alternatives.
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) A
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to U.S. military forces of
attack with a biological, chemical,
radiological, or nuclear agent or agents;
(3) a determination by the Secretary of
HHS that there is a public health
emergency, or a significant potential for
a public health emergency, that affects,
or has a significant potential to affect,
national security or the health and
security of U.S. citizens living abroad,
and that involves a biological, chemical,
radiological, or nuclear agent or agents,
or a disease or condition that may be
attributable to such agent or agents; or
(4) the identification of a material threat
by the Secretary of Homeland Security
under section 319F–2 of the Public
Health Service (PHS) Act (42 U.S.C.
247d–6b) sufficient to affect national
security or the health and security of
U.S. citizens living abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
E:\FR\FM\07SEN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 173 (Wednesday, September 7, 2016)]
[Notices]
[Pages 61685-61690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21351]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0731]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based
Products: Establishment Registration and Listing; Eligibility
Determination for Donors; and Current Good Tissue Practice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 61686]]
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements for FDA regulations related to human cells, tissues, and
cellular and tissue-based products (HCT/Ps) involving establishment
registration and listing using Form FDA 3356; eligibility determination
for donors; and current good tissue practice (CGTP).
DATES: Submit either written or electronic comments on the collection
of information by November 7, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-0731 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Human Cells, Tissues, and
Cellular and Tissue-Based Products: Establishment Registration and
Listing; Eligibility Determination for Donors; and Current Good Tissue
Practice.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 11601 Landsdown
St., 10A-12M, North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Human Cells, Tissues, and Cellular and Tissue-Based Products:
Establishment Registration and Listing; Eligibility Determination for
Donors; and Current Good Tissue Practice--OMB Control Number 0910-
0543--Extension
Under section 361 of the Public Health Service Act (the PHS Act)
(42 U.S.C. 264), FDA may issue and enforce regulations necessary to
prevent the introduction, transmission, or spread of communicable
diseases between the States or possessions or from foreign
[[Page 61687]]
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 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 (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.
[[Page 61688]]
The standard operating procedures (SOP) provisions under part 1271
include the following: (1) Sec. 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 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 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 2,218 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 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
[[Page 61689]]
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)).
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.
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
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Total................................... .............. .............. .............. .......................................... 2,404
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of records per Total annual Average burden per recordkeeping Total hours
record-keepers 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
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
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Total................................... .............. .............. .............. .......................................... 2,066,060
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b), 1271.200(c), 1271.230(a), 1271.250(a), and
1271.265(e).
\3\ Rounded to the nearest whole number.
[[Page 61690]]
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).................................. 1,551 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
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 2,079,281
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21351 Filed 9-6-16; 8:45 am]
BILLING CODE 4164-01-P
