[Federal Register: May 27, 2004 (Volume 69, Number 103)]
[Notices]               
[Page 30315-30317]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my04-67]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0026]

 
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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by June 
28, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

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

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--(OMB Control Number 0910-
0469)--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 from foreign countries into the States. 
As derivatives of the human body, all human cells, tissues, and 
cellular and tissue-based products (HCT/Ps) pose some risk of carrying 
pathogens that could potentially infect recipients or handlers. The 
regulations in part 1271 (21 CFR part 1271) require domestic and 
foreign establishments that recover, process, store, label, package, or 
distribute any HCT/P, 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 the initial establishment registration, and Sec.  
1271.25(a) and (b) identifies the required initial registration and 
HCT/P listing information. Section 1271.21(b) requires an annual update 
of the establishment registration. Section 1271.21(c)(ii) requires 
establishments to submit HCT/P listing updates when an HCT/P is changed 
as described in Sec.  1271.25(c). 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

[[Page 30316]]

and Tissue-Based Products (HCT/Ps);'' http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://forms.psc.gov/forms/FDA/fda.html
) (Sec. Sec.  1271.22 and 1271.25) to submit the required 

information. To further facilitate the ease and speed of submissions, 
electronic submission is accepted electronically at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/tissue/tisreg.htm
).

    Sections 207.20, 207.26, 207.30 (approved under OMB control number 
0910-0045), and 807.22(a) and (b) (approved under OMB control number 
0910-0387) (21 CFR 207.20, 207.26, 207.30, and 807.22(a) and (b)) 
already require establishments that manufacture drugs or devices to 
submit to FDA 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) 
(21 CFR 807.20(d)) require that manufacturers of HCT/P drugs (subject 
to review under an application submitted under section 505 of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) or under 
a biological products license application under section 351 of the PHS 
Act (42 U.S.C. 262)) and devices (subject to premarket review or 
notification, or exempt from notification, under an application 
submitted under the device provisions of the act or under a biological 
product license application under section 351 of the PHS Act) submit 
this registration and listing information using Form FDA 3356 instead 
of the multiple forms identified under parts 207 and 807. Therefore 
these establishments (FDA estimates a total of 67 (1 + 66) respondents 
as shown in table 1 of this document) 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 HCT/P, or 
perform donor screening or testing. In table 2 of this document, based 
on information from FDA's database system for the fiscal year (FY) 
2003, there are 1,003 establishments that have registered and listed 
with FDA. This number includes 552 establishments manufacturing 
conventional or ocular HCT/Ps, which are currently required to register 
and list with FDA. The remaining 451 establishments are manufacturers 
of hematopoietic stem cells derived from peripheral or cord blood, and 
reproductive cells and tissue. Although these establishments currently 
are not required to register and list, some have registered voluntarily 
and are therefore included in the burden estimate. Based on information 
from FDA's database for FY 2002, there were 484 listing updates and 12 
location/ownership amendments. When registration and listing 
requirements are implemented for all HCT/P establishments, i.e., when 
sections 207.20(f), 807.20(d), and 1271.3(d)(2) are effective, FDA 
estimates in table 1 of this document that approximately 367 (300 + 66 
+ 1) HCT/P establishments would initially register and list in addition 
to the 1,003 currently registered establishments.
    The burden estimates for the initial registration and listing and 
average hours per response are based on institutional experience with 
comparable reporting provisions for drugs, including biological 
products; 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.
    In the Federal Register of January 29, 2004 (69 FR 4303), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    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 per   Total Annual     Hours per     Total Hours
                                      Respondents      Response        Responses       Response
----------------------------------------------------------------------------------------------------------------
207.20(f)          Change to form                1               1               1           0.5             0.5
                    3356
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801.70(d)          ...............              66               1              66           0.5            33
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1271.10(b)(1) and  Initial                     300               1             300           0.75          225
 (b)(2),            registration
 1271.21(a), and    and listing
 1271.25(a) and
 (b)
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Total                                                                                                      258.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                           Table 2.--Estimated Initial (one-time) Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                        Annual
  21 CFR Section    Form FDA 3356       No. of       Frequency per   Total Annual     Hours per     Total Hours
                                      Respondents      Response        Responses       Response
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1271.10(b)(1) and  Annual                    1,003               1           1,003           0.5           501.5
 1271.21(b)         registration
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1271.10(b)(2),     Listing update              484               1             484           0.5           242
 1271.21(c)(ii),
 and 1271.25(c)
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1271.26            Registration                 12               1              12           0.25            3
                    amendment
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Total                                                                                                      746.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



[[Page 30317]]

    Dated: May 21, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-12011 Filed 5-26-04; 8:45 am]

BILLING CODE 4160-01-S