[Federal Register Volume 65, Number 130 (Thursday, July 6, 2000)]
[Notices]
[Pages 41674-41676]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16978]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1353]


Agency Information Collection Activities; Proposed Collection; 
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 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 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 
requirement relating to the regulation of FDA's current good 
manufacturing practice (CGMP) and related regulations for blood and 
blood components.

DATES:  Submit written comments on the collection of information by 
September 5, 2000.

ADDRESSES:  Submit written comments on the collection of information to 
the Dockets Management Branch (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: Karen L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

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: (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.

Current Good Manufacturing Practices and Related Regulations for 
Blood and Blood Components--Parts 606 and 640 (21 CFR Parts 606 and 
640) (OMB Control 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

[[Page 41675]]

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 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) (21 CFR 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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden<SUP>1</SUP>
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                                                      Annual
         21 CFR Section<SUP>2</SUP>              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 Recordkeeping Burden<SUP>1</SUP>
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                                                      Annual
         21 CFR Section<SUP>2</SUP>              No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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606.100(b)                           322<SUP>3</SUP>               1             322              24           7,728
606.100(c)                           152<SUP>4</SUP>              26           4,000               1           4,000
606.110(a)                            68<SUP>5</SUP>               5             340               0.5           170
606.151(e)                           322<SUP>3</SUP>              12           3,864               0.083         321
606.160                              322<SUP>3</SUP>           1,677         540,000               0.5       270,000

[[Page 41676]]

 
606.165                              152<SUP>4</SUP>           3,553         540,000               0.083      44,820
606.170(a)                           322<SUP>3</SUP>              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), 640.56(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: June 27, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-16978 Filed 7-5-00; 8:45 am]
BILLING CODE 4160-01-F