82 FR 16040 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 61 (March 31, 2017)

Page Range		16040-16044
FR Document		2017-06398
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Federal Register, Volume 82 Issue 61 (Friday, March 31, 2017)
[Federal Register Volume 82, Number 61 (Friday, March 31, 2017)]
[Notices]
[Pages 16040-16044]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-06398]


=======================================================================
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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; Eligibility Determination for Donors; and Current Good Tissue 
Practice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 1, 
2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0543. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: For specific questions for FDA related 
to this document, contact JonnaLynn Capezzuto, Office of Operations, 
Food and Drug Administration, Three White

[[Page 16041]]

Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-
796-3794.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Human Cells, Tissues, and Cellular and Tissue-Based Products: 
Establishment Registration and Listing; Eligibility Determination for 
Donors; and Current Good Tissue Practice--OMB Control Number 0910-
0543--Extension

    Under section 361 of the Public Health Service Act (the PHS Act) 
(42 U.S.C. 264), FDA may issue and enforce regulations necessary to 
prevent the introduction, transmission, or spread of communicable 
diseases between the States or possessions or from foreign countries 
into the States. As derivatives of the human body, all HCT/Ps pose some 
risk of carrying pathogens that could potentially infect recipients or 
handlers. FDA has issued regulations related to HCT/Ps involving 
establishment registration and listing using Form FDA 3356, eligibility 
determination for donors, and Current Good Tissue Practice (CGTP).

Establishment Registration and Listing; Form FDA 3356

    The regulations in part 1271 (21 CFR part 1271) require domestic 
and foreign establishments that recover, process, store, label, 
package, or distribute an HCT/P described in Sec.  1271.10(a), or that 
perform screening or testing of the cell or tissue donor to register 
with FDA (Sec.  1271.10(b)(1)) and submit a list of each HCT/P 
manufactured (Sec.  1271.10(b)(2)). Section 1271.21(a) requires an 
establishment to follow certain procedures for initial registration and 
listing of HCT/Ps, and Sec.  1271.25(a) and (b) identifies the required 
initial registration and HCT/P listing information. Section 1271.21(b), 
in brief, requires an annual update of the establishment registration. 
Section 1271.21(c)(ii) requires establishments to submit HCT/P listing 
updates if a change as described in Sec.  1271.25(c) has occurred. 
Section 1271.25(c) identifies the required HCT/P listing update 
information. Section 1271.26 requires establishments to submit an 
amendment if ownership or location of the establishment changes. FDA 
requires the use of a registration and listing form, Form FDA 3356: 
Establishment Registration and Listing for Human Cells, Tissues, and 
Cellular and Tissue-Based Products (HCT/Ps), to submit the required 
information (Sec. Sec.  1271.10, 1271.21, 1271.25, and 1271.26)). To 
further facilitate the ease and speed of submissions, electronic 
submission is accepted at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/TissueEstablishmentRegistration/default.htm.
    Form FDA 3356 is being revised as follows: (1) Adding import 
contact information including an email address and phone number; (2) 
deleting columns related to HCT/Ps subject to registration and listing 
under 21 CFR part 207 or 807; and (3) revising the instructions 
accordingly. The estimated burden is not affected by these changes.

Eligibility Determination for Donors

    In brief, FDA requires certain HCT/P establishments described in 
Sec.  1271.1(b) to determine donor eligibility based on donor screening 
and testing for relevant communicable disease agents and diseases 
except as provided under Sec.  1271.90. The documented determination of 
a donor's eligibility is made by a responsible person as defined in 
Sec.  1271.3(t) and is based on the results of required donor 
screening, which includes a donor medical history interview (defined in 
Sec.  1271.3(n)), and testing (Sec.  1271.50(a)). Certain records must 
accompany an HCT/P once the donor-eligibility determination has been 
made (Sec.  1271.55(a)). This requirement applies both to an HCT/P from 
a donor who is determined to be eligible as well as to an HCT/P from a 
donor who is determined to be ineligible or where the donor-eligibility 
determination is not complete if there is a documented urgent medical 
need, as defined in Sec.  1271.3(u) (Sec.  1271.60). Once the donor-
eligibility determination has been made, the HCT/P must be accompanied 
by a summary of records used to make the donor eligibility 
determination (Sec.  1271.55(b)), and a statement whether, based on the 
results of the screening and testing of the donor, the donor is 
determined to be eligible or ineligible (Sec.  1271.55(a)(2)). Records 
used in determining the eligibility of a donor, i.e., results and 
interpretations of testing for relevant communicable disease agents, 
the donor-eligibility determination, the name and address of the 
testing laboratory or laboratories, and the name of the responsible 
person (defined in Sec.  1271.3(t)) who made the donor-eligibility 
determination and the date of the determination, must be maintained 
(Sec.  1271.55(d)(1)). If any information on the donor is not in 
English, the original record must be maintained and translated to 
English, and accompanied by a statement of authenticity by the 
translator (Sec.  1271.55(d)(2)). HCT/P establishments must retain the 
records pertaining to a particular HCT/P at least 10 years after the 
date of its administration, or, if the date of administration is not 
known, then at least 10 years after the date of the HCT/P's 
distribution, disposition, or expiration, whichever is latest (Sec.  
1271.55(d)(4)).
    When a product is shipped in quarantine, as defined in Sec.  
1271.3(q), before completion of screening and testing, the HCT/P must 
be accompanied by records identifying the donor stating that the donor-
eligibility determination has not been completed and stating that the 
product must not be implanted, transplanted, infused, or transferred 
until completion of the donor-eligibility determination, except in 
cases of urgent medical need, as defined in Sec.  1271.3(u) (Sec.  
1271.60(c)). When a HCT/P is used in cases of documented urgent medical 
need, the results of any completed donor screening and testing, and a 
list of any required screening and testing that has not yet been 
completed also must accompany the HCT/P (Sec.  1271.60(d)(2)). When a 
HCT/P is used in cases of urgent medical need or from a donor who has 
been determined to be ineligible (as permitted under Sec.  1271.65), 
documentation by the HCT/P establishment is required showing that the 
recipient's physician received notification that the testing and 
screening were not complete (in cases of urgent medical need), and upon 
the completion of the donor-eligibility determination, of the results 
of the determination (Sec. Sec.  1271.60(d)(3) and (d)(4), and 
1271.65(b)(3)).
    An HCT/P establishment is also required to establish and maintain 
procedures for all steps that are performed in determining eligibility 
(Sec.  1271.47(a)), including the use of a product from a donor of 
viable, leukocyte-rich cells or tissue testing reactive for 
cytomegalovirus (Sec.  1271.85(b)(2)). The HCT/P establishment must 
record and justify any departure from a procedure relevant to 
preventing risks of communicable disease transmission at the time of 
its occurrence (Sec.  1271.47(d)).

Current Good Tissue Practice

    FDA requires HCT/P establishments to follow CGTP (Sec.  1271.1(b)). 
Section 1271.155(a) permits the submission of a request for FDA 
approval of an exemption from or an alternative to any requirement in 
subpart C or D of part 1271. Section 1271.290(c) requires 
establishments to affix a distinct identification code to each HCT/P 
that they manufacture that relates the HCT/P to the donor and to all 
records

[[Page 16042]]

pertaining to the HCT/P. Whenever an establishment distributes an HCT/P 
to a consignee, Sec.  1271.290(f) requires the establishment to inform 
the consignee, in writing, of the product tracking requirements and the 
methods the establishment uses to fulfill these requirements. Non-
reproductive HCT/P establishments described in Sec.  1271.10 are 
required under Sec.  1271.350(a)(1) and (a)(3) to investigate and 
report to FDA adverse reactions (defined in Sec.  1271.3(y)) using Form 
FDA-3500A (Sec.  1271.350(a)(2)). Form FDA-3500A is approved under OMB 
control number 0910-0291. Section 1271.370(b) and (c) requires 
establishments to include specific information either on the HCT/P 
label or with the HCT/P.
    The standard operating procedures (SOP) provisions under part 1271 
include the following: (1) Section 1271.160(b)(2) (receiving, 
investigation, evaluating, and documenting information relating to core 
CGTP requirements, including complaints, and for sharing information 
with consignees and other establishments); (2) Sec.  1271.180(a) (to 
meet core CGTP requirements for all steps performed in the manufacture 
of HCT/Ps); (3) Sec.  1271.190(d)(1) (facility cleaning and 
sanitization); (4) Sec.  1271.200(b) (cleaning, sanitizing, and 
maintenance of equipment); (5) Sec.  1271.200(c) (calibration of 
equipment); (6) Sec.  1271.230(a) and (c) (validation of a process and 
review and evaluation of changes to a validated process); (7) Sec.  
1271.250(a) (controls for labeling HCT/Ps); (8) Sec.  1271.265(e) 
(receipt, predistribution shipment, availability for distribution, and 
packaging and shipping of HCT/Ps); (9) Sec.  1271.265(f) (suitable for 
return to inventory); (10) Sec.  1271.270(b) (records management 
system); (11) Sec.  1271.290(b)(1) (system of HCT/P tracking); and (12) 
Sec.  1271.320(a) (review, evaluation, and documentation of complaints 
as defined in Sec.  1271.3(aa)).
    Section 1271.155(f) requires an establishment operating under the 
terms of an exemption or alternative to maintain documentation of FDA's 
grant of the exemption or approval and the date on which it began 
operating under the terms of the exemption or alternative. Section 
1271.160(b)(3) requires the quality program of an establishment that 
performs any step in the manufacture of HCT/Ps to document corrective 
actions relating to core CGTP requirements. Section 1271.160(b)(6) 
requires documentation of HCT/P deviations. Section 1271.160(d) 
requires, in brief, documentation of validation of computer software if 
the establishment relies upon it to comply with core CGTP requirements. 
Section 1271.190(d)(2) requires documentation of all cleaning and 
sanitation activities performed to prevent contamination of HCT/Ps. 
Section 1271.195(d) requires documentation of environmental control and 
monitoring activities. Section 1271.200(e) requires documentation of 
all equipment maintenance, cleaning, sanitizing, calibration, and other 
activities. Section 1271.210(d) requires, in brief, documentation of 
the receipt, verification, and use of each supply or reagent. Section 
1271.230(a) requires documentation of validation activities and results 
when the results of processing described in Sec.  1271.220 cannot be 
fully verified by subsequent inspection and tests. Section 1271.230(c) 
requires that when changes to a validated process subject to 
1271.230(a) occur, documentation of the review and evaluation of the 
process and revalidation, if necessary, must occur. Section 1271.260(d) 
and (e) requires documentation of any corrective action taken when 
proper storage conditions are not met and documentation of the storage 
temperature for HCT/Ps. Section 1271.265(c)(1) requires documentation 
that all release criteria have been met before distribution of an HCT/
P. Section 1271.265(c)(3) requires documentation of any departure from 
a procedure relevant to preventing risks of communicable disease 
transmission at the time of occurrence. Section 1271.265(e) requires 
documentation of the activities in paragraphs (a) through (d) of this 
section, which must include identification of the HCT/P and the 
establishment that supplied the HCT/P, activities performed and the 
results of each activity, date(s) of activity, quantity of HCT/P 
subject to the activity, and disposition of the HCT/P. Section 
1271.270(a) requires documentation of each step in manufacturing 
required in part 1271, subparts C and D. Section 1271.270(e) requires 
documentation of the name and address, and a list of responsibilities 
of any establishment that performs a manufacturing step for the 
establishment. Section 1271.290(d) and (e) require documentation of a 
method for recording the distinct identification code and type of each 
HCT/P distributed to a consignee to enable tracking from the consignee 
to the donor and to enable tracking from the donor to the consignee or 
final disposition. Section 1271.320(b) requires an establishment to 
maintain a record of each complaint that it receives. The complaint 
file must contain sufficient information about each complaint for 
proper review and evaluation of the complaint and for determining 
whether the complaint is an isolated event or represents a trend.
    Section 1271.420(a) requires importers of HCT/Ps to notify FDA 
District Director having jurisdiction over the port of entry through 
which the HCT/Ps are offered for import. The HCT/Ps must be held intact 
or transported under quarantine until they are inspected and released 
by FDA.
    Respondents to this information collection are establishments that 
recover, process, store, label, package or distribute any HCT/P, or 
perform donor screening or testing. The estimates provided are based on 
most recent available information from FDA's database system and trade 
organizations. The hours per response and hours per record are based on 
data provided by the Eastern Research Group, or FDA experience with 
similar recordkeeping or reporting requirements.
    There are an estimated 2,218 HCT/P establishments (conventional 
tissue, eye tissue, peripheral blood stem cell, stem cell products from 
cord blood, reproductive tissue, and sperm banks), including 667 
manufacturers of HCT/P products regulated under the Federal Food, Drug, 
and Cosmetic Act and section 351 of the PHS Act (42 U.S.C. 262), that 
have registered and listed with FDA. In addition, we estimate that 182 
new establishments have registered with FDA (Sec. Sec.  1271.10(b)(1) 
and (b)(2) and 1271.25(a) and (b)). There are an estimated 1,221 
listing updates (Sec. Sec.  1271.10(b)(2), 1271.21(c)(ii), and 
1271.25(c)) and 588 location/ownership amendments (Sec.  1271.26).
    Under Sec.  1271.55(a), an estimated total of 2,206,890 HCT/Ps 
(which include conventional tissues, eye tissues, hematopoetic stem 
cells/progenitor cells, and reproductive cells and tissues), and an 
estimated total of 2,066,890 non-reproductive cells and tissues (total 
HCT/Ps minus reproductive cells and tissues) are distributed per year 
by an estimated 1,551 establishments (2,218 - 667 = 1,551) with 
approved applications).
    Under Sec.  1271.60(c) and (d)(2), FDA estimates that 1,375 
establishments shipped an estimated 572,000 HCT/P under quarantine, and 
that an estimated 25 establishments requested 78 exemptions from or 
alternative to any requirement under part 1271, subpart C or D, 
specifically under Sec.  1271.155(a).
    Under Sec. Sec.  1271.290(c) and 1271.370(b) and (c), the estimated 
1,561 non-reproductive HCT/P establishments label each of their 
2,066,890 HCT/Ps with certain information. These

[[Page 16043]]

establishments are also required to inform their consignees in writing 
of the requirements for tracking and of their established tracking 
system under Sec.  1271.290(f).
    FDA estimates 34 HCT/P establishments submitted 166 adverse 
reaction reports with 136 involving a communicable disease (Sec.  
1271.350(a)(1)).
    FDA estimates that 182 new establishments will create SOPs, and 
that 2,218 establishments will review and revise existing SOPs 
annually.
    FDA estimates that 1,109 HCT/P establishments (2,218 x 50 percent = 
1,109) and 781 non-reproductive HCT/P establishments (1,561 x 50 
percent = 781) record and justify a departure from the procedures 
(Sec. Sec.  1271.47(d) and 1271.265(c)(3)).
    Under Sec.  1271.50(a), HCT/P establishments are required to have a 
documented medical history interview about the donor's medical history 
and relevant social behavior as part of the donor's relevant medical 
records for each of the estimated total of 109,019 donors (which 
include conventional tissue donors, eye tissue donors, peripheral and 
cord blood stem cell donors, and reproductive cell and tissue donors), 
and the estimated total of 103,419 non-reproductive cells and tissue 
donors (total donors minus reproductive cell and tissue donors).
    FDA estimates that 665 HCT/P establishments (2,218 x 30 percent = 
665) document an urgent medical need of the product to notify the 
physician using the HCT/P (Sec. Sec.  1271.60(d)(3) and 1271.65(b)(3)).
    FDA also estimates that 1,774 HCT/P establishments (2,218 x 80 
percent = 1,774) have to maintain records for an average of 2 contract 
establishments to perform their manufacturing process (Sec.  
1271.270(e) and 1,249 HCT/P establishments (1,561 x 80 percent = 
1,249)) maintain an average of 5 complaint records annually (Sec.  
1271.320(b)).
    FDA estimates that under 1271.420(a), 200 establishments will 
submit 560 reports of HCT/Ps offered for imports. In some cases, the 
estimated burden may appear to be lower or higher than the burden 
experienced by individual establishments. The estimated burden in these 
charts is an estimated average burden, taking into account the range of 
impact each regulation may have on respondents.
    In the Federal Register of September 7, 2016 (81 FR 61685), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. One comment was received 
beyond the scope of the four information collection topics solicited 
and therefore we have not discussed it in this document.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR section                    Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses                                                      \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.10(b)(1) and 1271.21(b) \2\............           2,218               1           2,218  .5 (30 minutes)...........................           1,109
1271.10(b)(1) and (b)(2), 1271.21(a), and                182               1             182  .75 (45 minutes)..........................             137
 1271.25(a) and (b) \2\.
1271.10(b)(2), 1271.21(c)(2)(ii) and                   1,221               1           1,221  .5 (30 minutes)...........................             611
 1271.25(c) \2\.
1271.26 \2\.................................             588               1             588  .25 (15 minutes)..........................             147
1271.155(a).................................              25            3.12              78  3.........................................             234
1271.350(a)(1) and (a)(3)...................              34            4.88             166  1.........................................             166
1271.420(a).................................             200             2.8             560  .25 (15 minutes)..........................             140
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total...................................  ..............  ..............  ..............  ..........................................           2,544
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
                                               recordkeepers   recordkeeper       records                                                       \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
New SOPs \2\................................             182               1             182  48........................................           8,736
SOP Update \2\..............................           2,218               1           2,218  24........................................          53,232
1271.47(d)..................................           1,109               1           1,109  1.........................................           1,109
1271.50(a)..................................           2,218           49.15         109,019  5.........................................         545,095
1271.55(d)(1)...............................           2,218           49.15         109,019  1.........................................         109,019
1271.55(d)(2)...............................           2,218               1           2,218  1.........................................           2,218
1271.55(d)(4)...............................           2,218               1           2,218  120.......................................         266,160
1271.60(d)(3) and (d)(4) 1271.65(b)(3)(iii).             665               1             665  2.........................................           1,330
1271.155(f).................................              25            3.12              78  .25 (15 minutes)..........................              20
1271.160(b)(3) and (b)(6)...................           1,561              12          18,732  1.........................................          18,732
1271.160(d).................................           1,561              12          18,732  1.........................................          18,732
1271.190(d)(2)..............................           1,561              12          18,732  1.........................................          18,732
1271.195(d).................................           1,561              12          18,732  1.........................................          18,732
1271.200(e).................................           1,561              12          18,732  1.........................................          18,732
1271.210(d).................................           1,561              12          18,732  1.........................................          18,732
1271.230(a).................................           1,561              12          18,732  1.........................................          18,732
1271.230(c).................................           1,561               1           1,561  1.........................................           1,561
1271.260(d).................................           1,561              12          18,732  .25 (15 minutes)..........................           4,683
1271.260(e).................................           1,561             365         569,765  .083 (5 minutes)..........................          47,291
1271.265(c)(1)..............................           1,561        1,324.08       2,066,890  .083 (5 minutes)..........................         171,552
1271.265(c)(3)..............................             781               1             781  1.........................................             781

[[Page 16044]]

 
1271.265(e).................................           1,561        1,324.08       2,066,890  .083 (5 minutes)..........................         171,552
1271.270(a).................................           1,561        1,324.08       2,066,890  .25 (15 minutes)..........................         516,723
1271.270(e).................................           1,774               2           3,548  .5 (30 minutes)...........................           1,774
1271.290(d) and (e).........................           1,561           66.25         103,419  .25 (15 minutes)..........................          25,855
1271.320(b).................................           1,249               5           6,245  1.........................................           6,245
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total...................................  ..............  ..............  ..............  ..........................................       2,066,060
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b), 1271.200(c), 1271.230(a), 1271.250(a),
  1271.265(e), 1271.265(f), 1271.270(b) and (d), 1271.290(b)(1), and 1271.320(a).
\3\ Rounded to the nearest whole number.


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
               21 CFR section                    Number of      disclosures    Total annual          Average burden per disclosure          Total hours
                                                respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.55(a)..................................           1,551        1,422.88       2,206,890  .5 (30 minutes)...........................       1,103,445
1271.60(c) and (d)(2).......................           1,375             416         572,000  .5 (30 minutes)...........................         286,000
1271.290(c).................................           1,561        1,324.08       2,066,890  .083 (5 minutes)..........................         171,552
1271.290(f).................................           1,561               1           1,561  1.........................................           1,561
1271.370(b) and (c).........................           1,561        1,324.08       2,066,890  .25 (15 minutes)..........................         516,723
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total...................................  ..............  ..............  ..............  ..........................................       2,079,281
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: March 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-06398 Filed 3-30-17; 8:45 am]
 BILLING CODE 4164-01-P
16040 Federal Register / Vol. 82, No. 61 / Friday, March 31, 2017 / Notices

Revocable Trust dated October 7, 2008, electronically to A. Federal Reserve Bank of
James P. Stein Trust Number One, and Comments.applications@stls.frb.org: Philadelphia (William Spaniel, Senior
the Inter Vivos Stock Trust of Simon G. 1. Craig L. Weiss, Memphis, Vice President) 100 North 6th Street,
Stein IV FBO James P. Stein, Muscatine, Tennessee; to acquire shares of Paragon Philadelphia, Pennsylvania 19105–
Iowa; James P. Stein as trustee of the Financial Solutions, Inc., and thereby 1521. Comments can also be sent
James P. Stein Revocable Trust dated indirectly acquire shares of Paragon electronically to
December 16, 2005 and the Inter Vivos Bank, both of Memphis, Tennessee. Comments.applications@phil.frb.org:
Stock Trust of Simon G. Stein IV FBO C. Federal Reserve Bank of Dallas 1. Hamilton Bancorp, Inc., Ephrata,
James P. Stein, Muscatine, Iowa; (Robert L. Triplett III, Senior Vice Pennsylvania; to become a bank holding
Timothy J. Stein as trustee of the President) 2200 North Pearl Street, company by acquiring Stonebridge
Timothy J. Stein Revocable Trust dated Dallas, Texas 75201–2272: Bank, West Chester, Pennsylvania.
1. Keitha Ann Nilsson, Daingerfield,
August 10, 2012, James P. Stein Trust Board of Governors of the Federal Reserve
Texas, and Mickey Wiley Carter, Jr.,
Number One, and the Inter Vivos Stock System, March 28, 2017.
Omaha, Texas; to join the Holton Family
Trust of Simon G. Stein IV FBO James Yao-Chin Chao,
Group, a group acting in concert; to
P. Stein, Lakeway, Texas; Carrie A. Assistant Secretary of the Board.
retain voting shares of WSB Bancshares,
Zorich as trustee of the Carrie A. Zorich Inc., and indirectly retain shares of [FR Doc. 2017–06395 Filed 3–30–17; 8:45 am]
Revocable Trust dated July 23, 2007, Wellington State Bank, both of BILLING CODE 6210–01–P
James P. Stein Trust Number One, and Wellington, Texas.
the Inter Vivos Stock Trust of Simon G.
Stein IV FBO James P. Stein, Muscatine, Board of Governors of the Federal Reserve
System, March 28, 2017. DEPARTMENT OF HEALTH AND
Iowa; Maryann Bramhall-Lambert as HUMAN SERVICES
Yao-Chin Chao,
trustee of the GST Exempt Trust for
benefit of James P. Stein Family, Iowa Assistant Secretary of the Board.
Food and Drug Administration
City, Iowa; GST Exempt Trust for benefit [FR Doc. 2017–06394 Filed 3–30–17; 8:45 am]
[Docket No. FDA–2013–N–0731]
of James P. Stein Family, Muscatine, BILLING CODE 6210–01–P

Iowa; Daniel P. Stein Revocable Trust Agency Information Collection
dated October 7, 2008, Muscatine, Iowa; Activities; Submission for Office of
James P. Stein Revocable Trust dated FEDERAL RESERVE SYSTEM
Management and Budget Review;
December 16, 2005, Muscatine, Iowa; Formations of, Acquisitions by, and Comment Request; Human Cells,
Timothy J. Stein Revocable Trust dated Mergers of Bank Holding Companies Tissues, and Cellular and Tissue-
August 10, 2012, Lakeway, Texas; Carrie Based Products: Establishment
A. Zorich Revocable Trust dated July 23, The companies listed in this notice Registration and Listing; Eligibility
2007, Muscatine, Iowa; James P. Stein have applied to the Board for approval, Determination for Donors; and Current
Trust Number One, Muscatine, Iowa; pursuant to the Bank Holding Company Good Tissue Practice
Inter Vivos Stock Trust of Simon G. Act of 1956 (12 U.S.C. 1841 et seq.)
Stein IV FBO James P. Stein, Muscatine, (BHC Act), Regulation Y (12 CFR part AGENCY: Food and Drug Administration,
Iowa; Thomas L. Lambert, Iowa City, 225), and all other applicable statutes HHS.
Iowa; Francis L. Lambert, Rock Island, and regulations to become a bank ACTION: Notice.
Illinois; and Susan M. Yeast, West holding company and/or to acquire the
Liberty, Iowa; in addition to, James P. assets or the ownership of, control of, or SUMMARY: The Food and Drug
Stein; Timothy J. Stein; Carrie A. Zorich; the power to vote shares of a bank or Administration (FDA or we) is
Daniel P. Stein; Benjamin L. Parks, Iowa bank holding company and all of the announcing that a proposed collection
City, Iowa; William M. Parks; and Ruth banks and nonbanking companies of information has been submitted to the
M. Parks, Muscatine, Iowa, as members owned by the bank holding company, Office of Management and Budget
of Sawyer Group Family Council which including the companies listed below. (OMB) for review and clearance under
votes and controls shares owned by the The applications listed below, as well the Paperwork Reduction Act of 1995.
Ann F. Parks Special Trust Number as other related filings required by the DATES: Fax written comments on the
One; GST Exempt Trust for benefit of Board, are available for immediate collection of information by May 1,
James P. Stein Family; Daniel P. Stein inspection at the Federal Reserve Bank 2017.
Revocable Trust dated October 7, 2008; indicated. The applications will also be
ADDRESSES: To ensure that comments on
James P. Stein Revocable Trust dated available for inspection at the offices of
the information collection are received,
December 16, 2005; Timothy J. Stein the Board of Governors. Interested
OMB recommends that written
persons may express their views in
Revocable Trust dated August 10, 2012; comments be faxed to the Office of
writing on the standards enumerated in
Carrie A. Zorich Revocable Trust dated Information and Regulatory Affairs,
the BHC Act (12 U.S.C. 1842(c)). If the
July 23, 2007; James P. Stein Trust OMB, Attn: FDA Desk Officer, FAX:
proposal also involves the acquisition of
Number One; and the Inter Vivos Stock 202–395–7285, or emailed to oira_
a nonbanking company, the review also
Trust of Simon G. Stein IV FBO James submission@omb.eop.gov. All
includes whether the acquisition of the
P. Stein, as a group acting in concert; to comments should be identified with the
nonbanking company complies with the
retain voting shares of Central OMB control number 0910–0543. Also
standards in section 4 of the BHC Act
Bancshares, Inc. and thereby indirectly include the FDA docket number found
sradovich on DSK3GMQ082PROD with NOTICES

(12 U.S.C. 1843). Unless otherwise
retain shares of CBI Bank & Trust, in brackets in the heading of this
noted, nonbanking activities will be
Muscatine, Iowa, and The Farmers and document.
conducted throughout the United States.
Mechanics Bank, Galesburg, Illinois. Unless otherwise noted, comments FOR FURTHER INFORMATION CONTACT: For
B. Federal Reserve Bank of St. Louis regarding each of these applications specific questions for FDA related to
(David L. Hubbard, Senior Manager) must be received at the Reserve Bank this document, contact JonnaLynn
P.O. Box 442, St. Louis, Missouri indicated or the offices of the Board of Capezzuto, Office of Operations, Food
63166–2034. Comments can also be sent Governors not later than April 27, 2017. and Drug Administration, Three White

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Federal Register / Vol. 82, No. 61 / Friday, March 31, 2017 / Notices 16041

Flint North, 10A63, 11601 Landsdown further facilitate the ease and speed of must retain the records pertaining to a
St., North Bethesda, MD 20852, 301– submissions, electronic submission is particular HCT/P at least 10 years after
796–3794. accepted at http://www.fda.gov/ the date of its administration, or, if the
SUPPLEMENTARY INFORMATION: In BiologicsBloodVaccines/Guidance date of administration is not known,
compliance with 44 U.S.C. 3507, FDA ComplianceRegulatoryInformation/ then at least 10 years after the date of
has submitted the following proposed EstablishmentRegistration/Tissue the HCT/P’s distribution, disposition, or
collection of information to OMB for EstablishmentRegistration/default.htm. expiration, whichever is latest
review and clearance. Form FDA 3356 is being revised as (§ 1271.55(d)(4)).
follows: (1) Adding import contact When a product is shipped in
Human Cells, Tissues, and Cellular and information including an email address quarantine, as defined in § 1271.3(q),
Tissue-Based Products: Establishment and phone number; (2) deleting before completion of screening and
Registration and Listing; Eligibility columns related to HCT/Ps subject to testing, the HCT/P must be
Determination for Donors; and Current registration and listing under 21 CFR accompanied by records identifying the
Good Tissue Practice—OMB Control part 207 or 807; and (3) revising the donor stating that the donor-eligibility
Number 0910–0543—Extension instructions accordingly. The estimated determination has not been completed
Under section 361 of the Public burden is not affected by these changes. and stating that the product must not be
Health Service Act (the PHS Act) (42 implanted, transplanted, infused, or
Eligibility Determination for Donors
U.S.C. 264), FDA may issue and enforce transferred until completion of the
regulations necessary to prevent the In brief, FDA requires certain HCT/P donor-eligibility determination, except
introduction, transmission, or spread of establishments described in § 1271.1(b) in cases of urgent medical need, as
communicable diseases between the to determine donor eligibility based on defined in § 1271.3(u) (§ 1271.60(c)).
States or possessions or from foreign donor screening and testing for relevant When a HCT/P is used in cases of
countries into the States. As derivatives communicable disease agents and documented urgent medical need, the
of the human body, all HCT/Ps pose diseases except as provided under results of any completed donor
some risk of carrying pathogens that § 1271.90. The documented screening and testing, and a list of any
could potentially infect recipients or determination of a donor’s eligibility is required screening and testing that has
handlers. FDA has issued regulations made by a responsible person as defined not yet been completed also must
related to HCT/Ps involving in § 1271.3(t) and is based on the results accompany the HCT/P (§ 1271.60(d)(2)).
establishment registration and listing of required donor screening, which When a HCT/P is used in cases of urgent
using Form FDA 3356, eligibility includes a donor medical history medical need or from a donor who has
determination for donors, and Current interview (defined in § 1271.3(n)), and been determined to be ineligible (as
Good Tissue Practice (CGTP). testing (§ 1271.50(a)). Certain records permitted under § 1271.65),
must accompany an HCT/P once the documentation by the HCT/P
Establishment Registration and Listing; donor-eligibility determination has been establishment is required showing that
Form FDA 3356 made (§ 1271.55(a)). This requirement the recipient’s physician received
The regulations in part 1271 (21 CFR applies both to an HCT/P from a donor notification that the testing and
part 1271) require domestic and foreign who is determined to be eligible as well screening were not complete (in cases of
establishments that recover, process, as to an HCT/P from a donor who is urgent medical need), and upon the
store, label, package, or distribute an determined to be ineligible or where the completion of the donor-eligibility
HCT/P described in § 1271.10(a), or that donor-eligibility determination is not determination, of the results of the
perform screening or testing of the cell complete if there is a documented determination (§§ 1271.60(d)(3) and
or tissue donor to register with FDA urgent medical need, as defined in (d)(4), and 1271.65(b)(3)).
(§ 1271.10(b)(1)) and submit a list of § 1271.3(u) (§ 1271.60). Once the donor- An HCT/P establishment is also
each HCT/P manufactured eligibility determination has been made, required to establish and maintain
(§ 1271.10(b)(2)). Section 1271.21(a) the HCT/P must be accompanied by a procedures for all steps that are
requires an establishment to follow summary of records used to make the performed in determining eligibility
certain procedures for initial registration donor eligibility determination (§ 1271.47(a)), including the use of a
and listing of HCT/Ps, and § 1271.25(a) (§ 1271.55(b)), and a statement whether, product from a donor of viable,
and (b) identifies the required initial based on the results of the screening and leukocyte-rich cells or tissue testing
registration and HCT/P listing testing of the donor, the donor is reactive for cytomegalovirus
information. Section 1271.21(b), in determined to be eligible or ineligible (§ 1271.85(b)(2)). The HCT/P
brief, requires an annual update of the (§ 1271.55(a)(2)). Records used in establishment must record and justify
establishment registration. Section determining the eligibility of a donor, any departure from a procedure relevant
1271.21(c)(ii) requires establishments to i.e., results and interpretations of testing to preventing risks of communicable
submit HCT/P listing updates if a for relevant communicable disease disease transmission at the time of its
change as described in § 1271.25(c) has agents, the donor-eligibility occurrence (§ 1271.47(d)).
occurred. Section 1271.25(c) identifies determination, the name and address of
the required HCT/P listing update the testing laboratory or laboratories, Current Good Tissue Practice
information. Section 1271.26 requires and the name of the responsible person FDA requires HCT/P establishments
establishments to submit an amendment (defined in § 1271.3(t)) who made the to follow CGTP (§ 1271.1(b)). Section
if ownership or location of the donor-eligibility determination and the 1271.155(a) permits the submission of a
establishment changes. FDA requires date of the determination, must be request for FDA approval of an
sradovich on DSK3GMQ082PROD with NOTICES

the use of a registration and listing form, maintained (§ 1271.55(d)(1)). If any exemption from or an alternative to any
Form FDA 3356: Establishment information on the donor is not in requirement in subpart C or D of part
Registration and Listing for Human English, the original record must be 1271. Section 1271.290(c) requires
Cells, Tissues, and Cellular and Tissue- maintained and translated to English, establishments to affix a distinct
Based Products (HCT/Ps), to submit the and accompanied by a statement of identification code to each HCT/P that
required information (§§ 1271.10, authenticity by the translator they manufacture that relates the HCT/
1271.21, 1271.25, and 1271.26)). To (§ 1271.55(d)(2)). HCT/P establishments P to the donor and to all records

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16042 Federal Register / Vol. 82, No. 61 / Friday, March 31, 2017 / Notices

pertaining to the HCT/P. Whenever an with core CGTP requirements. Section proper review and evaluation of the
establishment distributes an HCT/P to a 1271.190(d)(2) requires documentation complaint and for determining whether
consignee, § 1271.290(f) requires the of all cleaning and sanitation activities the complaint is an isolated event or
establishment to inform the consignee, performed to prevent contamination of represents a trend.
in writing, of the product tracking HCT/Ps. Section 1271.195(d) requires Section 1271.420(a) requires
requirements and the methods the documentation of environmental control importers of HCT/Ps to notify FDA
establishment uses to fulfill these and monitoring activities. Section District Director having jurisdiction over
requirements. Non-reproductive HCT/P 1271.200(e) requires documentation of the port of entry through which the
establishments described in § 1271.10 all equipment maintenance, cleaning, HCT/Ps are offered for import. The
are required under § 1271.350(a)(1) and sanitizing, calibration, and other HCT/Ps must be held intact or
(a)(3) to investigate and report to FDA activities. Section 1271.210(d) requires, transported under quarantine until they
adverse reactions (defined in in brief, documentation of the receipt, are inspected and released by FDA.
§ 1271.3(y)) using Form FDA–3500A verification, and use of each supply or Respondents to this information
(§ 1271.350(a)(2)). Form FDA–3500A is reagent. Section 1271.230(a) requires collection are establishments that
approved under OMB control number documentation of validation activities recover, process, store, label, package or
0910–0291. Section 1271.370(b) and (c) and results when the results of distribute any HCT/P, or perform donor
requires establishments to include screening or testing. The estimates
processing described in § 1271.220
specific information either on the HCT/ provided are based on most recent
cannot be fully verified by subsequent
P label or with the HCT/P. available information from FDA’s
inspection and tests. Section
The standard operating procedures database system and trade
1271.230(c) requires that when changes
(SOP) provisions under part 1271 organizations. The hours per response
to a validated process subject to and hours per record are based on data
include the following: (1) Section
1271.230(a) occur, documentation of the provided by the Eastern Research
1271.160(b)(2) (receiving, investigation,
review and evaluation of the process Group, or FDA experience with similar
evaluating, and documenting
and revalidation, if necessary, must recordkeeping or reporting
information relating to core CGTP
occur. Section 1271.260(d) and (e) requirements.
requirements, including complaints,
requires documentation of any There are an estimated 2,218 HCT/P
and for sharing information with
corrective action taken when proper establishments (conventional tissue, eye
consignees and other establishments);
storage conditions are not met and tissue, peripheral blood stem cell, stem
(2) § 1271.180(a) (to meet core CGTP
requirements for all steps performed in documentation of the storage cell products from cord blood,
the manufacture of HCT/Ps); (3) temperature for HCT/Ps. Section reproductive tissue, and sperm banks),
§ 1271.190(d)(1) (facility cleaning and 1271.265(c)(1) requires documentation including 667 manufacturers of HCT/P
sanitization); (4) § 1271.200(b) (cleaning, that all release criteria have been met products regulated under the Federal
sanitizing, and maintenance of before distribution of an HCT/P. Section Food, Drug, and Cosmetic Act and
equipment); (5) § 1271.200(c) 1271.265(c)(3) requires documentation section 351 of the PHS Act (42 U.S.C.
(calibration of equipment); (6) of any departure from a procedure 262), that have registered and listed
§ 1271.230(a) and (c) (validation of a relevant to preventing risks of with FDA. In addition, we estimate that
process and review and evaluation of communicable disease transmission at 182 new establishments have registered
changes to a validated process); (7) the time of occurrence. Section with FDA (§§ 1271.10(b)(1) and (b)(2)
§ 1271.250(a) (controls for labeling HCT/ 1271.265(e) requires documentation of and 1271.25(a) and (b)). There are an
Ps); (8) § 1271.265(e) (receipt, the activities in paragraphs (a) through estimated 1,221 listing updates
predistribution shipment, availability (d) of this section, which must include (§§ 1271.10(b)(2), 1271.21(c)(ii), and
for distribution, and packaging and identification of the HCT/P and the 1271.25(c)) and 588 location/ownership
shipping of HCT/Ps); (9) § 1271.265(f) establishment that supplied the HCT/P, amendments (§ 1271.26).
(suitable for return to inventory); (10) activities performed and the results of Under § 1271.55(a), an estimated total
§ 1271.270(b) (records management each activity, date(s) of activity, of 2,206,890 HCT/Ps (which include
system); (11) § 1271.290(b)(1) (system of quantity of HCT/P subject to the conventional tissues, eye tissues,
HCT/P tracking); and (12) § 1271.320(a) activity, and disposition of the HCT/P. hematopoetic stem cells/progenitor
(review, evaluation, and documentation Section 1271.270(a) requires cells, and reproductive cells and
of complaints as defined in documentation of each step in tissues), and an estimated total of
§ 1271.3(aa)). manufacturing required in part 1271, 2,066,890 non-reproductive cells and
Section 1271.155(f) requires an subparts C and D. Section 1271.270(e) tissues (total HCT/Ps minus
establishment operating under the terms requires documentation of the name and reproductive cells and tissues) are
of an exemption or alternative to address, and a list of responsibilities of distributed per year by an estimated
maintain documentation of FDA’s grant any establishment that performs a 1,551 establishments (2,218 ¥ 667 =
of the exemption or approval and the manufacturing step for the 1,551) with approved applications).
date on which it began operating under establishment. Section 1271.290(d) and Under § 1271.60(c) and (d)(2), FDA
the terms of the exemption or (e) require documentation of a method estimates that 1,375 establishments
alternative. Section 1271.160(b)(3) for recording the distinct identification shipped an estimated 572,000 HCT/P
requires the quality program of an code and type of each HCT/P under quarantine, and that an estimated
establishment that performs any step in distributed to a consignee to enable 25 establishments requested 78
tracking from the consignee to the donor
sradovich on DSK3GMQ082PROD with NOTICES

the manufacture of HCT/Ps to document exemptions from or alternative to any
corrective actions relating to core CGTP and to enable tracking from the donor to requirement under part 1271, subpart C
requirements. Section 1271.160(b)(6) the consignee or final disposition. or D, specifically under § 1271.155(a).
requires documentation of HCT/P Section 1271.320(b) requires an Under §§ 1271.290(c) and 1271.370(b)
deviations. Section 1271.160(d) establishment to maintain a record of and (c), the estimated 1,561 non-
requires, in brief, documentation of each complaint that it receives. The reproductive HCT/P establishments
validation of computer software if the complaint file must contain sufficient label each of their 2,066,890 HCT/Ps
establishment relies upon it to comply information about each complaint for with certain information. These

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Document Created: 2017-03-31 01:38:01
Document Modified: 2017-03-31 01:38:01
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by May 1, 2017.
Contact		For specific questions for FDA related to this document, contact JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301- 796-3794.
FR Citation		82 FR 16040
DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 61 (March 31, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
