[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://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://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://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
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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