[Federal Register Volume 68, Number 125 (Monday, June 30, 2003)]
[Notices]
[Pages 38712-38713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16495]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0268]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Biological Products: Reporting of Biological Product 
Deviations in Manufacturing

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 
requirements relating to the reporting of biological product deviations 
in manufacturing.

DATES:  Submit written or electronic comments on the collection of 
information by August 29, 2003.

ADDRESSES:  Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. All comments should be identified with 
the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of 
Management Programs (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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

[[Page 38713]]

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.

Biological Products: Reporting of Biological Product Deviations in 
Manufacturing (OMB Control Number 0910-0458)--Extension

    Under section 351 of the Public Health Service Act (42 U.S.C. 262), 
all biological products, including human blood and blood components, 
offered for sale in interstate commerce must be licensed and meet 
standards designed to ensure the continued safety, purity, and potency 
of such products. In addition, the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 351) provides that drugs and devices (including 
human blood and blood components) are adulterated if they do not 
conform with Current Good Manufacturing Practice (CGMP) assuring that 
they meet the requirements of the act. All establishments manufacturing 
human blood and blood components are required to register with FDA, and 
comply with the CGMP regulations for human blood and blood components 
(parts 211 and 606 (21 CFR parts 211 and 606)). Transfusion services 
are required under 42 CFR 493.1273(a) to comply with part 606 and 21 
CFR 640 as they pertain to the performance of manufacturing activities. 
FDA regards biological product deviation reporting to be an essential 
tool in its directive to protect public health by establishing and 
maintaining surveillance programs that provide timely and useful 
information.
    Section 600.14 (21 CFR 600.14) requires the licensed manufacturer 
who holds the biological product license, for other than human blood 
and blood components, and who had control over the product when the 
deviation occurred, to report to the Center for Biologics Evaluation 
and Research (CBER) as soon as possible but not to exceed 45 calendar 
days after acquiring information reasonably suggesting that a 
reportable event has occurred. Section 606.171 requires a licensed 
manufacturer of human blood and blood components, including Source 
Plasma; an unlicensed registered blood establishment; or a transfusion 
service who had control over the product when the deviation occurred, 
to report to CBER as soon as possible but not to exceed 45 calendar 
days after acquiring information reasonably suggesting that a 
reportable event has occurred.
    Respondents to this collection of information are the licensed 
manufacturers of biological products other than human blood and blood 
components, unlicensed registered blood establishments, and transfusion 
services. Based on information from CBER's databases for fiscal year 
(FY) 2002, the agency estimates that 115 licensed manufacturers of 
biological products other than human blood and blood components 
submitted 476 error and accident reports under Sec.  600.14. FDA also 
estimates 207 licensed manufacturers of human blood and blood 
components, including Source Plasma, submitted 27,000 error and 
accident reports under Sec.  606.171. In addition, FDA estimates 2,800 
unlicensed registered blood establishments and 3,221 transfusion 
services submitted a total of 6,446 error and accident reports. The 
number of total annual responses is based on the number of biological 
product deviation reports CBER received in FY 2002. The rate of 
submission is not expected to change significantly in the next few 
years. Based on information from industry, the estimated average time 
to complete a deviation report is 2 hours. The availability of the 
standardized report FDA Form 3486, and the ability to submit this 
report electronically further streamlines the report submission 
process. Activities such as investigating, changing SOP's or processes, 
and follow-up are currently required under parts 211 (approved under 
OMB control numbers 0910-0139 and 0910-0353), 606 (approved under OMB 
control number 0910-0116), and 21 CFR part 820 (approved under OMB 
control number 0910-0073) and, therefore, are not included in the 
burden calculation for the separate requirement of submitting a 
deviation report to FDA.
    FDA estimates the burden of this collection of information as 
follows:

                                                          Estimated Annual Reporting Burden\1\
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                                                    FDA Form                           Annual Frequency per  Total Annual    Hours per
                 21 CFR Section                      Number       No. of Respondents         Response          Responses     Response      Total Hours
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600.14                                              3486                115                     4.1             476             2               952
606.171\2\                                          3486                207                   130.4          27,000             2            54,000
606.171\3\                                          3486              6,021                     1.1           6,446             2            12,892
  Total                                             3486              6,343            ....................  33,922        ............      67,844
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Licensed manufacturers of human blood and blood components, including Source Plasma.
\3\ Unlicensed registered blood establishments and transfusion services (2,800+3,221=6,021).


    Dated: June 24, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16495 Filed 6-27-03; 8:45 am]
BILLING CODE 4160-01-S