[Federal Register Volume 65, Number 239 (Tuesday, December 12, 2000)]
[Notices]
[Pages 77633-77635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-31592]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1642]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Establishment Registration and Listing Requirements 
for Human Cells, Tissues, and Cellular and Tissue-Based Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 relating to FDA regulations for human tissue intended for 
transplantation.

DATES: Submit written or electronic comments on the collection of 
information by February 12, 2001.

ADDRESSES: Submit electronic comments on the collection of

[[Page 77634]]

information to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. Submit written comments on the collection of 
information to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All 
comments should be identified with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

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 request 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: (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.

Establishment Registration and Listing of Requirements for Human 
Cellular and Tissue-Based Products--21 CFR Part 1270 (OMB Control 
Number 0910-0372)--Extension

    Under section 361 of the Public Health Service Act (the PHS Act) 
(42 U.S.C. 264), FDA issued regulations to prevent the transmission of 
human immunodeficiency virus (HIV), hepatitis B, hepatitis C, and other 
organisms causing infectious disease through the use of human tissue 
for transplantation. The regulations in part 1271 (21 CFR part 1271) 
require establishments that recover, process, store, label, package, or 
distribute any human cell, tissue, and cellular and tissue-based 
product (HCT/P), or that perform donor screening or testing, to submit 
an initial establishment registration and HCT/P list to FDA. 
Subsequently, establishments must submit an annual update to their 
establishment registration. In addition, establishments are required to 
submit HCT/P list updates, if any, and amendments whenever an 
establishment changes ownership or locations. FDA provides a 
registration and listing form (Form FDA 3356) to facilitate the ease 
and speed of submissions.
    Sections 1271.10(b) and 1271.21(a) and (b) require the initial 
establishment registration and HCT/P listing information. Sections 
1271.10(b) and 1271.21(b) require the annual establishment registration 
by domestic and foreign HCT/P establishments that are solely regulated 
under section 361 of the PHS Act and this part. Sections 1271.10(b), 
1271.21(c)(ii), and 1271.25(c) require domestic and foreign HCT/P 
establishments to submit HCT/P listing updates only when an HCT/P is 
changed, added, or discontinued, and when there has been a material 
change to information submitted previously to the agency. If no change 
has occurred since the previous submission, an update is not required. 
Sections 1271.10(b) and 1271.26 require domestic and foreign HCT/P 
establishments to submit an amendment, but only when the establishment 
makes a change in location or ownership.
    Sections 207.20, 207.26, 207.30, 807.20, 807.26, and 807.30 (21 CFR 
207.20, 207.26, 207.30, 807.20, 807.26, and 807.30) already require 
establishments that manufacture drug or device products to submit 
initial establishment registration and product listing, as well as 
annual establishment registration, product listing updates, and 
location and ownership amendments. Sections 207.20(f) and 807.20(d) 
require that manufacturers of HCT/P drugs and devices submit this 
registration and listing information using Form FDA 3356 instead of the 
multiple forms identified under parts 207 and 807 (21 CFR parts 207 and 
807). Therefore, these establishments will incur only a one-time burden 
to transition from the use of several forms to the use of one form.
    Respondents to this information collection are establishments that 
recover, process, store, label, package, or distribute any human cells, 
tissue, and cellular and tissue-based product. Based on information 
provided to FDA by industry representatives, trade organizations, and 
professional societies, the estimated number of establishments 1,225 
(i.e., approximately 110 conventional tissue, 114 eye tissue banks, 400 
peripheral blood stem cells, 25 stem cell products from cord blood, 400 
reproductive tissue, 110 sperm banks, and 66 licensed biological 
products and approved devices). Our burden estimates for the annual 
frequency per response and average hours per response are based on 
institutional experience with comparable reporting provisions for 
drugs, including biological products, and devices, information from 
industry representatives and trade organizations, and data provided by 
the Eastern Research Group, a consulting firm hired by FDA to prepare 
an economic analysis of the potential economic impact on sperm banks 
and other reproductive tissue facilities.
    Table 1 of this document provides the initial, one-time estimated 
burden for HCT/P establishment registration and HCT/P listing. This 
information may be submitted simultaneously on the same form, Form FDA 
3356. We estimate that 0.75 hour of staff time will be needed for each 
initial submission.
    In table 1 of this document we also include the one-time burden for 
HCT/P drug and device manufacturers regulated under parts 207 and 807. 
Parts 207 and 807 require that drug and device manufacturers submit 
initial establishment registration and product listing, annual 
establishment registration, product listing updates, and location/
ownership amendments. Sections 207.20(f) and 807.20(d) change only the 
reporting format and require use of only one form, new Form FDA 3356, 
in place of the multiple forms currently required, i.e., Forms FDA-2656 
and FDA-2657 for drug manufacturers, and Forms FDA-2891, FDA-2891(a), 
and FDA-2892 for device manufacturers. Therefore, the one-time 
reporting burden estimate for Secs. 207.20(f) and 807.20(d) in table 1 
of this document reflects only the time necessary to transition from 
the use of current multiple forms to the use of Form FDA 3356.
    Table 2 of this document provides the estimate of the ongoing 
annual reporting burden for establishment registration. In

[[Page 77635]]

addition, table 2 of this document sets out estimated reporting burdens 
for HCT/P listing updates and establishment location or ownership 
amendments that would occur during any given year. If there is no 
change to an HCT/P listing, establishment location or ownership, a 
submission is not required. It is estimated that ongoing annual 
registration, updates and amendments require 0.50 hour, while the 
initial submission requires on average 0.75 hour. In addition, table 2 
of this document shows that the average hours per response is 0.25 hour 
for the HCT/P listing updates and location/ownership amendments, which 
are required only when a change is made. In table 2 of this document, 
we also estimate that approximately 5 percent of the 1,159 
establishments, or 58 establishments, will make changes to HCT/P's, 
location, or ownership in any one year after the initial registration 
and listing.
    FDA estimates the burden of this collection of information as 
follows:

                           Table 1.--Estimated Initial (One-Time) Reporting Burden\1\
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                                                             Annual
      21 CFR Section         Form FDA 3356     No. of       Frequency   Total Annual    Hours per    Total Hours
                                             Respondents  per Response    Responses     Response
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207.20(f)                                        1             1             1             0.5           0.5
807.20(f)                                       65             1            65             0.5          32.5
1271.10(b) and 1271.25(a)   Inital           1,159             1         1,159             0.75        869.25
 and (b)                     registration
                             and listing
Total                                                                                                  902.25
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                  Table 2.--Estimated Annual Reporting Burden\1\
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                                                             Annual
      21 CFR Section         Form FDA 3356     No. of       Frequency   Total Annual    Hours per    Total Hours
                                             Respondents  per Response    Responses     Response
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1271.10(b) and 1271.21(b)   Annual           1,159             1         1,159             0.5         579.5
                             registration
1271.10(b), 1271.21(c),     Listing update      58             1            58             0.5          29
 and 1271.25(c)
1271.10(b) and 1271.26      Location/           58             1            58             0.25         14.5
                             ownership
                             amendment
Total                                                                                                 623
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: December 5, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-31592 Filed 12-11-00; 8:45 am]
BILLING CODE 4160-01-F