[Federal Register Volume 62, Number 150 (Tuesday, August 5, 1997)]
[Notices]
[Pages 42131-42133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20495]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0311]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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 reinstatement of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
provisions relating to the regulation of FDA's current good 
manufacturing practice

[[Page 42132]]

(CGMP) and related regulations for blood and blood components.

DATES: Submit written comments on the collection of information by 
October 6, 1997.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1223.

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 reinstatement 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 listed below.
    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.

CGMP and Related Regulations for Blood and Blood Components--Parts 
606 and 640 (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

[[Page 42133]]

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. 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:

                                        Estimated Annual Reporting Burden                                       
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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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There are no capital costs or operating and maintenance costs associated with this information collection.      


                                      Estimated Annual Recordkeeping Burden                                     
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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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There are no capital costs or operating and maintenance costs associated with this information collection.      


    Dated: July 28, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-20495 Filed 8-4-97; 8:45 am]
BILLING CODE 4160-01-F