[Federal Register Volume 65, Number 195 (Friday, October 6, 2000)]
[Notices]
[Pages 59851-59852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25698]


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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