[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 Burden<SUP>1                                  
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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 Burden<SUP>1                                
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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