[Federal Register Volume 62, Number 238 (Thursday, December 11, 1997)]
[Notices]
[Pages 65276-65277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32458]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0311]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
following proposed collection of information listed below has been
submitted to the Office of Management and Budget (OMB) for review and
clearance under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on this collection of information by
January 12, 1998.
ADDRESSES: Submit written comments on this collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA.
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: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.
CGMP and Related Regulations for Blood and Blood Components--(21
CFR Parts 606 and 640)--(OMB Control Number 0910-0116)--
Reinstatement
Under the statutory requirements contained in the Public Health
Service Act (42 U.S.C. 262), no blood, blood component, or derivative
may move in interstate commerce unless: (1) It is propagated or
manufactured and prepared at an establishment holding an unsuspended
and unrevoked license; (2) the product complies with regulatory
standards designed to ensure safety, purity, and potency; and (3) it
bears a label plainly marked with the product's proper name, its
manufacturer, and expiration date.
The CGMP and related regulations implement FDA's statutory
authority to ensure the safety, purity, and potency of blood and blood
components. The information collection requirements in the CGMP
regulations provide FDA with the necessary information to perform its
duty to ensure the safety, purity, and potency of blood and blood
components. These requirements establish accountability and
traceability in the processing and handling of blood and blood
components and enable FDA to perform meaningful inspections. The
recordkeeping requirements serve preventative and remedial purposes.
The disclosure requirements identify the various blood and blood
components and important properties of the product, demonstrate that
the CGMP requirements have been met, and facilitate the tracing of a
product back to its original source. The reporting requirements inform
FDA of any deviations that occur and that may require immediate
corrective action.
Section 606.100(b) requires that written standard operating
procedures (SOP's) be maintained for the collection, processing,
compatibility testing, storage and distribution of blood and blood
components used for transfusion and manufacturing purposes. Section
606.100(c) requires the review of all pertinent records to a lot or
unit of blood prior to release of the lot or unit. Any unexplained
discrepancy or failure of a lot or unit of final product to meet any of
its specifications must be thoroughly investigated, and the
investigation, including conclusions and followup, must be recorded.
Section 606.110(a) requires a physician to certify in writing that the
donor's health permits plateletpheresis or leukapheresis if a variance
from additional regulatory standards for a specific product is used
when obtaining the product from a specific donor for a specific
recipient. Section 606.151(e) requires that records of expedited
transfusions in life-threatening emergencies be maintained. So that all
steps in the collection, processing, compatibility testing, storage and
distribution, quality control, and transfusion reaction reports and
complaints for each unit of blood and blood components can be clearly
traced, Sec. 606.160 requires that legible and indelible
contemporaneous records of each significant step be made and maintained
for no less than 5 years. Section 606.165 requires that distribution
and receipt records be maintained to facilitate recalls, if necessary.
Section 606.170(a) requires records to be maintained of any reports of
complaints of adverse reactions as a result of blood collection or
transfusion. Each such report must be thoroughly investigated, and a
written report, including conclusions and followup, must be prepared
and maintained. Section 606.170(b) requires that fatal complications of
blood collections and transfusions be reported to FDA as soon as
possible and that a written report shall be submitted within 7 days. In
addition to the CGMP's in part 606, there are regulations in part 640
that require additional standards for blood and blood components:
Secs. 640.3(a) and (f), 640.4(a), 640.25(b)(4) and (c)(1), 640.27(b),
640.31(b), 640.33(b), 640.51(b), 640.53(c), 640.56(b) and (d), 640.61,
640.63(b)(3), (e)(1) and (e)(3), 640.65(b)(2), 640.66, 640.71(b)(1),
640.72, 640.73, and 640.76(a) and (b). The information collection
requirements and estimated burdens for these regulations are included
in the part 606 burden estimates, as described below.
The recordkeeping requirements for Secs. 640.3(a)(1), 640.4(a)(1),
and 640.66, which address the maintenance of SOP's, are included in the
estimate for Sec. 606.100(b); the recordkeeping requirements for
Sec. 640.27(b), which addresses the maintenance of donor health records
for plateletpheresis, is included in the estimate for Sec. 606.110(a);
and the recordkeeping requirements for Secs. 640.3(a)(2), 640.3(f),
640.4(a)(2), 640.25(b)(4) and (c)(1), 640.31(b), 640.33(b), 640.51(b),
640.53(c), 640.56(b) and (d), 640.61, 640.63(b)(3), (e)(1), and (e)(3),
640.65(b)(2), 640.71(b)(1), 640.72, and 640.76(a) and (b), which
address the maintenance of various records, are included in the
estimate for Sec. 606.160. The reporting requirement in Sec. 640.73,
which addresses the reporting of fatal donor reactions, is included in
the estimate for Sec. 606.170(b).
Respondents to this collection of information are registered blood
establishments. There are an estimated 3,021 FDA registered blood
collection facilities in the United States that annually collect an
estimated 23,500,000 units of whole blood and source plasma. Of the
3,021 registered establishments, 1,799 establishments perform pheresis
collections and 278 establishments perform transfusions.
[[Page 65277]]
There are also an estimated 4,500 Health Care Financing Administration
registered transfusion services. The recordkeeping chart reflects the
estimate that 95 percent of the recordkeepers which collect 98 percent
of the blood supply had developed SOP's as part of their normal
business practice. Establishments may minimize burdens associated with
the CGMP and related regulations by using model SOP's developed by
blood organizations. These blood organizations represent almost all of
the registered establishments.
FDA estimates the burden of this information collection as follows:
Table 1.--Estimated Annual Reporting Burden1
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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606.170(b) 42 1 42 8 336
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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 Recordkeeping Burden1
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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606.100(b) 151 1 151 24 3,624
606.100(c) 151 3.6 550 3.6 550
606.110(a) 90 5 450 2.5 225
606.151(e) 239 12 2,868 1 239
606.160 151 3,112 470,000 1,556 234,956
606.165 151 3,112 470,000 258 38,958
606.170(a) 376 12 4,512 12 4,512
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: December 5, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-32458 Filed 12-10-97; 8:45 am]
BILLING CODE 4160-01-F