[Federal Register: October 6, 2000 (Volume 65, Number 195)]
[Notices]
[Page 59851-59852]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc00-93]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00N-1353]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Current Good Manufacturing Practices and
Related Regulations for Blood and Blood Components
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
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.
DATES: Submit written comments on the collection of information by
November 6, 2000.
ADDRESSES: Submit written comments on the 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:
Wendy Taylor, 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 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Current Good Manufacturing Practices (CGMP) and Related Regulations
for Blood and Blood Components (OMB Number 0910-0116)--Extension
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,
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) (21 CFR 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) (21 CFR 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 606.110(b) requires
establishments to request prior Center for Biologics Evaluation and
Research (CBER) approval for plasmapheresis of donors who do not meet
donor requirements. The regulation in 21 CFR 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, 21 CFR 606.160 requires that
legible and indelible contemporaneous records of each significant step
be made and maintained for no less than 5 years. The regulations in 21
CFR 606.165 require that distribution and receipt records be maintained
to facilitate recalls, if necessary. Section 606.170(a) (21 CFR
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 (21 CFR part 606), there are
regulations in part 640 (21 CFR part 640) that require additional
standards for blood and blood components as follows: Sections 640.2(f);
640.3(a); 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. Respondents to
this collection of information are licensed and unlicensed blood
establishments inspected by FDA, and other transfusion services
inspected by the Health Care Financing Administration (HCFA). Based on
FDA's registration system, there are an estimated 3,032 registered
blood establishments inspected by FDA of which 1,349 perform pheresis.
Based on information provided by HCFA, there are an estimated 3,400
transfusion services inspected by HCFA. An estimated 27 million units
of whole blood and blood components are collected annually. 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 customary and usual business practice.
Establishments may minimize burdens associated with the CGMP and
related regulations by using model SOP's developed by industries'
accreditation
[[Page 59852]]
organizations. These accreditation organizations represent almost all
registered blood establishments. The total annual responses in the
reporting chart for fatality reporting are based on an annual average
of fatality reports submitted to FDA. The annual frequency of
recordkeeping and total annual records, and the estimated reporting and
recordkeeping burden hours are based on information provided by
industry, and FDA's experience. Under Sec. 606.110(b), licensed
establishments submit supplements to their biologics license
applications to request prior CBER approval of plasmapheresis donors
who do not meet donor requirements. The information collection
requirements for Sec. 606.110(b) are reported under OMB control number
0910-0315.
In the Federal Register of July 6, 2000 (65 FR 41674), the agency
requested comments on the proposed collections of information. No
significant comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
21 CFR Section\2\ No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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606.170(b) 75 1 75 20 1,500
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\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).
Table 2.--Estimated Annual Reporting Burden\1\
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Annual
21 CFR Section\2\ No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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606.100(b) 322\3\ 1 322 24 7,728
606.100(c) 152\4\ 26 4,000 1 4,000
606.110(a) 68\5\ 5 340 0.5 170
606.151(e) 322\3\ 12 3,864 0.083 321
606.160 322\3\ 1,677 540,000 0.5 270,000
606.165 152\4\ 3,553 540,000 0.083 44,820
606.170(a) 322\3\ 12 3,864 1 3,864
Total 330,903
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\The recordkeeping requirements in 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 in Sec.
640.27(b), which address the maintenance of donor health records for plateletpheresis, are included in the
estimate for Sec. 606.110(a); and the recordkeeping requirements in Secs. 640.2(f), 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), 640.53(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.
\3\5 percent of HCFA and FDA-registered blood establishments (0.05 X (3,400+3,032))
\4\5 percent of FDA-registered establishments (3,032)
\5\5 percent of pheresis establishments (1,349)
Dated: October 2, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-25698 Filed 10-5-00; 8:45 am]
BILLING CODE 4160-01-F