[Federal Register Volume 71, Number 210 (Tuesday, October 31, 2006)]
[Notices]
[Pages 63772-63773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18313]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0421]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Biological Products: Reporting of Biological Product 
Deviations in Manufacturing; Forms FDA 3486 and 3486A

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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, and Forms FDA 3486 and 3486A.

DATES: Submit written or electronic comments on the collection of 
information by January 2, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(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: Jonna Capezzuto, Office of the Chief 
Information Officer (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 these topics: (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.

Biological Products: Reporting of Biological Product Deviations in 
Manufacturing; Forms FDA 3486 and 3486A (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 
biological products including human blood and blood components must 
comply with the applicable CGMP regulations (parts 211, 606, and 820 
(21 CFR parts 211, 606, and 820)). Transfusion services are required 
under 42 CFR 493.1271 to comply with 21 CFR parts 606 and 640 as they 
pertain to the performance of manufacturing activities. FDA regards 
biological product deviation (BPD) 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 requires the 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) or to the 
Center for Drugs Evaluation and Research (CDER) 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. The BPD reporting 
under 21 CFR 1271.350(b) for human cells, tissues, and cellular and 
tissue-based products is approved under OMB control number 0910-0559 
(expires November 30, 2007). Form FDA 3486 is used to submit BPDs under 
these regulations.
    Respondents to this collection of information are the licensed 
manufacturers of biological products other than human blood and blood 
components, licensed manufacturers of blood and blood components 
including Source Plasma, unlicensed registered blood establishments, 
and transfusion services. Based on information from FDA's database, 
there are an estimated 147 licensed manufacturers of biological 
products other than human blood and blood components, 194 licensed 
manufacturers of human blood and blood components, including Source 
Plasma, and 1,230 unlicensed registered blood establishments. Based on 
the Center for Medicare and Medicaid Services records, there are an 
estimated 4,980 transfusion services. The number of licensed 
manufacturers and total annual responses under Sec.  600.14 include the 
estimates for both CBER and CDER. The number of total annual responses 
is based on the number of

[[Page 63773]]

BPD reports FDA received in fiscal year 2005. 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 form, Form FDA 3486, and the ability to submit this report 
electronically to CBER (CDER does not currently accept electronic 
filings) further streamlines the report submission process.
    CBER is developing an addendum to Form FDA 3486. The web-based 
addendum (Form FDA 3486A) would request additional information when a 
BPD report has been reviewed by FDA and evaluated as a possible recall. 
The additional information requested would include information not 
contained in the Form FDA 3486 such as: (1) Distribution pattern, (2) 
method of consignee notification, (3) consignee(s) of products for 
further manufacture, (4) additional product information, and (5) 
updated product disposition. This information would be requested by 
CBER through e-mail notification to the submitter of the BPD report. 
This information would be used by CBER for purposes of recall 
classification. We plan to use Form FDA 3486A for only biological 
products regulated by CBER. We do not plan to use this form for 
biological products regulated by CDER because they receive very few BPD 
reports and do not accept electronic filings. CBER estimates that 5 
percent of the total BPD reports submitted to CBER would need 
additional information submitted in the addendum. CBER estimates it 
would take between 15 to 45 minutes to complete the addendum. For 
calculation purposes, CBER is using one-half hour.
    Activities such as investigating, changing standard operating 
procedures or processes, and followup are currently required under 21 
CFR parts 211 (approved under OMB control no. 0910-0139, expires 
September 30, 2008), 606 (approved under OMB control no. 0910-0116, 
expires December 31, 2008), and 820 (approved under OMB control no. 
0910-0073, expires September 30, 2007) and, therefore, are not included 
in the burden calculation for the separate requirement of submitting a 
BPD report to FDA.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              FDA Form           No. of        Annual Frequency     Total Annual        Hours per
              21 CFR Section                   Number         Respondents        per Response        Responses          Responses         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
600.14                                               3486                147               2.73                401                2.0                802
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.171\2\                                           3486                194             169.89             32,958                2.0             65,916
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.171\3\                                           3486              6,210               1.50              9,311                2.0             18,622
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 3486A\4\              6,551               0.33              2,133                0.5              1,067
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                      ..............  .................  .................  .................  .................             86,407
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or 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 (1,230 + 4,980 = 6,210).
\4\ Five percent of the total annual responses to CBER (42,653 x 0.05 = 2,133).


    Dated: October 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18313 Filed 10-30-06; 8:45 am]
BILLING CODE 4160-01-S