[Federal Register: January 29, 2004 (Volume 69, Number 19)]
[Notices]               
[Page 4303-4305]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ja04-51]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0026]

 
Agency Information Collection Activities; Proposed Collection; 
Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based 
Products; Establishment Registration and Listing; Form FDA 3356

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

[[Page 4304]]

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 establishment registration and listing for human cells, 
tissues, and cellular and tissue-based products (HCT/Ps) and the 
associated Form FDA 3356 used to report establishment registration and 
listing information.

DATES:  Submit written or electronic comments on the collection of 
information by March 29, 2004.

ADDRESSES:  Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Submit written comments on the collection of information to 

the Division of Dockets Management (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 
Management Programs (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 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; Form FDA 3356--21 CFR 1271 (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 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 section 
1271.25(a) and (b) identify 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 section 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 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 (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) 
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

[[Page 4305]]

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.
    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
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207.20(f)           Change to Form                   1               1             1          0.5           0.5
                     3356
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807.20(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 and
 1271.21(a), 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 Annual 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
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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.


    Dated: January 21, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-1839 Filed 1-28-04; 8:45 am]

BILLING CODE 4160-01-S