Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records, 28486-28488 [E8-11057]

Download as PDF 28486 Federal Register / Vol. 73, No. 96 / Friday, May 16, 2008 / Notices in the next 3 years. However, to avoid counting this burden as zero, FDA has estimated the burden at one respondent making one submission a year for a total of one annual submission. The hours per response values were estimated as follows: First, we assumed that the information requested in the guidance is readily available to the submitter. We expect that the submitter will need to gather information from appropriate persons in the submitter’s company and to prepare this information for submission to FDA. The submitter will almost always merely need to copy existing documentation. We believe that this effort should take no longer than 3 hours per submission. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers Activity Develop documentation process 1There Annual Frequency per Recordkeeping 1 Total Annual Records 1 1 Total Hours 16 16 are no capital costs or operating and maintenance costs associated with this collection of information. In determining the estimated annual recordkeeping burden, FDA estimated that at least 90 percent of firms maintain documentation, such as packing codes, batch records, and inventory records, as part of their basic food production or import operations. Therefore, the recordkeeping burden was calculated as the time required for the 10 percent of firms that may not be currently maintaining this documentation to develop and maintain documentation, such as batch records and inventory records. In previous information collection requests, this recordkeeping burden was estimated to be 16 hours per record. FDA has retrained its prior estimate of 16 hours per record for the recordkeeping burden. As shown in table 1 of this document, FDA estimates that one respondent will make one submission per year. Although FDA estimates that only 1 out of 10 firms will not be currently maintaining the necessary documentation, to avoid counting the recordkeeping burden for the 1 submission per year as 1/10 of a recordkeeper, FDA estimates that 1 recordkeeper will take 16 hours to develop and maintain documentation recommended by the guidance. Dated: May 8, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–10985 Filed 5–15–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES collection of information to OMB for review and clearance. Food and Drug Administration Adverse Experience Reporting for Licensed Biological Products; and General Records—(OMB Control Number 0910–0308)—Extension Under the Public Health Service Act (42 U.S.C. 262), FDA is required to ensure the marketing of only those biological products which are safe and effective. FDA must, therefore, be informed of all adverse experiences occasioned by the use of licensed biological products. FDA issued the adverse experience reporting (AER) requirements in part 600 (21 CFR part 600) to enable FDA to take actions necessary for the protection of the public health in response to reports of adverse experiences related to licensed biological products. The primary purpose of FDA’s AER system is to flag potentially serious safety problems with licensed biological products, focusing especially on newly licensed products. Although premarket testing discloses a general safety profile of a biological product’s comparatively common adverse effects, the larger and more diverse patient populations exposed to the licensed biological product provides the opportunity to collect information on rare, latent, and long-term effects. Reports are obtained from a variety of sources, including patients, physicians, foreign regulatory agencies, and clinical investigators. Information derived from the AER system contributes directly to increased public health protection because such information enables FDA to recommend important changes to the product’s labeling (such as adding a new warning), to initiate removal of a biological product from the market when necessary, and to assure the manufacturer has taken adequate corrective action if necessary. The regulation in § 600.80(c)(1) requires licensed manufacturers to report each adverse experience that is both serious and unexpected, whether [Docket No. FDA–2008–N–0073] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by June 16, 2008. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974, or e-mailed to baguilar@omb.eop.gov. All comments should be identified with the OMB control number 0910–0308. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: sroberts on PROD1PC70 with NOTICES Hours per Record Jonna Capezzuto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 4659. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 16:18 May 15, 2008 Jkt 214001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\16MYN1.SGM 16MYN1 28487 Federal Register / Vol. 73, No. 96 / Friday, May 16, 2008 / Notices foreign or domestic, as soon as possible but in no case later than 15-calendar days of initial receipt of the information by the licensed manufacturer. These are known as postmarketing 15-day Alert reports. Section 600.80(c)(1) also requires licensed manufacturers to submit any followup reports within 15calendar days of receipt of new information or as requested by FDA. Section 600.80(e) requires licensed manufacturers to submit a 15-day Alert report for an adverse experience obtained from a postmarketing clinical study only if there is a reasonable possibility that the product caused the adverse experience. Section 600.80(c)(2) requires licensed manufacturers to report each adverse experience not reported in a postmarketing 15-day Alert report at quarterly intervals, for 3 years from the date of issuance of the biologics license, and then at annual intervals. The majority of these periodic reports will be submitted annually because a large percentage of currently licensed biological products have been licensed longer than 3 years. Section 600.80(i) requires licensed manufacturers to maintain for a period of 10 years records of all adverse experiences known to the licensed manufacturer, including raw data and any correspondence relating to the adverse experiences. Section 600.81 requires licensed manufacturers to submit, at an interval of every 6 months, information about the quantity of the product distributed under the biologics license, including the quantity distributed to distributors. These semiannual distribution reports provide FDA with important information about products distributed under biologics licenses, including the quantity, certain lot numbers, labeled date of expiration, number of dosage units, and date of release. Under § 600.90, a licensed manufacturer may submit a waiver request for any requirements that applies to the licensed manufacturer under § 600.80 and 600.81. A waiver request submitted under § 600.90 must include supporting documentation. Manufacturers of biological products for human use must keep records of each step in the manufacture and distribution of a product including any recalls. These recordkeeping requirements serve preventative and remedial purposes by establishing accountability and traceability in the manufacture and distribution of products. These requirements also enable FDA to perform meaningful inspections. Section 600.12 requires, among other things, concurrently with the performance of each step that all records of each step in the manufacture and distribution of a product be made and retained for no less than 5 years after the records of manufacture have been completed or 6 months after the latest expiration date for the individual product, whichever represents a later date. In addition, manufacturers must maintain records of sterilization of equipment and supplies, animal necropsy records, and records in cases of divided manufacturing of a product. Section 600.12(b)(2) requires manufacturers to maintain complete records pertaining to the recall from distribution of any product. Respondents to this collection of information are manufacturers of biological products. Under table 1 of this document, the number of respondents is based on the estimated number of manufacturers that submitted the required information to the Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research, FDA, in fiscal year (FY) 2006. Based on information obtained from FDA’s database system, there were 88 licensed biologics manufacturers. This number excludes those manufacturers who produce blood and blood components and in-vitro diagnostic licensed products, because § 600.80(k) specifically exempts manufacturers of these products from adverse experience reporting requirements. The total annual responses are based on the estimated number of submissions received annually by FDA in FY 2006. However, not all manufacturers have submissions in a given year and some may have multiple submissions. There were an estimated 23,835 15-day Alert reports, 21,872 periodic reports, and 179 lot distribution reports submitted to FDA. The number of 15-day Alert reports for postmarketing studies under § 600.80(e) is included in the total number of 15day Alert reports. FDA received 6 requests for waiver under § 600.90, all of which were granted. The hours per response are based on FDA experience. The burden hours required to complete the MedWatch Form for § 600.80(c)(1), (e), and (f) are reported under OMB control no. 0910–0291. In the Federal Register of February 15, 2008 (73 FR 8881), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 600.80(c)(1) and 600.80(e) 88 270.85 23,835 1 23,835 600.80(c)(2) 88 248.55 21,872 28 612,416 600.81 88 2.03 179 1 179 600.90 6 6 1 6 1 Total sroberts on PROD1PC70 with NOTICES 1 There 636,436 are no capital costs or operating and maintenance costs associated with this collection of information. Under table 2 of this document, the number of respondents is based on the number of manufacturers subject to those regulations. Based on information obtained from FDA’s database system, there were 303 licensed manufacturers of biological products in FY 2006. However, the number of recordkeepers VerDate Aug<31>2005 16:18 May 15, 2008 Jkt 214001 listed for § 600.12(a) through (e) excluding (b)(2) is estimated to be 112. This number excludes manufacturers of blood and blood components because their burden hours for recordkeeping have been reported under 21 CFR 606.160 in OMB control no. 0910–0116. The total annual records is based on the PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 annual average of lots released (5,291), number of recalls made (1,841), and total number of adverse experience reports received (45,707) in FY 2006. The hours per record are based on FDA experience. FDA estimates the burden of this recordkeeping as follows: E:\FR\FM\16MYN1.SGM 16MYN1 28488 Federal Register / Vol. 73, No. 96 / Friday, May 16, 2008 / Notices TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. Of Recordkeepers 21 CFR Section Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 600.12 112 47.24 5,291 32 169,312 600.12(b)(2) 303 6.08 1,841 24 44,184 88 519.40 45,707 1 45,707 600.80(i) Total 1 There 259,203 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 13, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–11057 Filed 5–15–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental & Craniofacial Research; Notice of Closed Meeting sroberts on PROD1PC70 with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Board of Scientific Counselors, National Institute of Dental and Craniofacial Research. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Dental & Craniofacial Research, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Board of Scientific Counselors, National Institute of Dental and Craniofacial Research. Date: June 9–11, 2008. Time: June 9, 2008, 7 p.m. to 9 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institutes of Health, Building 30, 30 Convent Drive, Room 117, Bethesda, MD 20892. Time: June 10, 2008, 8 a.m. to 8 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institutes of Health, Building 30, 30 Convent Drive, Room 117, Bethesda, MD 20892. VerDate Aug<31>2005 16:18 May 15, 2008 Jkt 214001 Time: June 11, 2008, 8 a.m. to 12:30 p.m. Agenda: To review and evaluate personal qualifications and performance, and competence of individual investigators. Place: National Institutes of Health, Building 30, 30 Convent Drive, Room 117, Bethesda, MD 20892. Contact Person: Norman S Braveman, Assistant to the Director, NIH—NIDCR, 31 Center Drive, Bldg. 31, Room 5B55, Bethesda, MD 20892, 301 594–2089, norman.braveman@nih.gov. Information is also available on the Institute’s/Center’s home page: http:// www.nidcr.nih.gov/about/ CouncilCommittees.asp, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS) Dated: May 8, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–10836 Filed 5–15–08; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Frm 00065 Fmt 4703 Sfmt 4703 Dated: May 8, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–10837 Filed 5–15–08; 8:45 am] BILLING CODE 4140–01–M Center for Scientific Review; Notice of Closed Meeting PO 00000 Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Inner Ear Hair Cells. Date: May 22, 2008. Time: 1 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Daniel R. Kenshalo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5176, MSC 7844, Bethesda, MD 20892, 301–435– 1255, kenshalod@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Pathobiology of Kidney Disease Study Section, June 12, 2008, 8 a.m. to June 13, 2008, 5 p.m., Hotel Deca, 4507 Brooklyn Avenue, NE., Seattle, WA 98105 which was published in the Federal Register on May 2, 2008, 73 FR 24296–24298. The meeting will be held one day only June 12, 2008. The meeting time and location remain the same. The meeting is closed to the public. E:\FR\FM\16MYN1.SGM 16MYN1

Agencies

[Federal Register Volume 73, Number 96 (Friday, May 16, 2008)]
[Notices]
[Pages 28486-28488]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11057]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0073]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Adverse Experience 
Reporting for Licensed Biological Products; and General Records

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June 
16, 2008.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0308. Also 
include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Adverse Experience Reporting for Licensed Biological Products; and 
General Records--(OMB Control Number 0910-0308)--Extension

    Under the Public Health Service Act (42 U.S.C. 262), FDA is 
required to ensure the marketing of only those biological products 
which are safe and effective. FDA must, therefore, be informed of all 
adverse experiences occasioned by the use of licensed biological 
products. FDA issued the adverse experience reporting (AER) 
requirements in part 600 (21 CFR part 600) to enable FDA to take 
actions necessary for the protection of the public health in response 
to reports of adverse experiences related to licensed biological 
products. The primary purpose of FDA's AER system is to flag 
potentially serious safety problems with licensed biological products, 
focusing especially on newly licensed products. Although premarket 
testing discloses a general safety profile of a biological product's 
comparatively common adverse effects, the larger and more diverse 
patient populations exposed to the licensed biological product provides 
the opportunity to collect information on rare, latent, and long-term 
effects. Reports are obtained from a variety of sources, including 
patients, physicians, foreign regulatory agencies, and clinical 
investigators. Information derived from the AER system contributes 
directly to increased public health protection because such information 
enables FDA to recommend important changes to the product's labeling 
(such as adding a new warning), to initiate removal of a biological 
product from the market when necessary, and to assure the manufacturer 
has taken adequate corrective action if necessary.
    The regulation in Sec.  600.80(c)(1) requires licensed 
manufacturers to report each adverse experience that is both serious 
and unexpected, whether

[[Page 28487]]

foreign or domestic, as soon as possible but in no case later than 15-
calendar days of initial receipt of the information by the licensed 
manufacturer. These are known as postmarketing 15-day Alert reports. 
Section 600.80(c)(1) also requires licensed manufacturers to submit any 
followup reports within 15-calendar days of receipt of new information 
or as requested by FDA.
    Section 600.80(e) requires licensed manufacturers to submit a 15-
day Alert report for an adverse experience obtained from a 
postmarketing clinical study only if there is a reasonable possibility 
that the product caused the adverse experience. Section 600.80(c)(2) 
requires licensed manufacturers to report each adverse experience not 
reported in a postmarketing 15-day Alert report at quarterly intervals, 
for 3 years from the date of issuance of the biologics license, and 
then at annual intervals. The majority of these periodic reports will 
be submitted annually because a large percentage of currently licensed 
biological products have been licensed longer than 3 years. Section 
600.80(i) requires licensed manufacturers to maintain for a period of 
10 years records of all adverse experiences known to the licensed 
manufacturer, including raw data and any correspondence relating to the 
adverse experiences. Section 600.81 requires licensed manufacturers to 
submit, at an interval of every 6 months, information about the 
quantity of the product distributed under the biologics license, 
including the quantity distributed to distributors. These semiannual 
distribution reports provide FDA with important information about 
products distributed under biologics licenses, including the quantity, 
certain lot numbers, labeled date of expiration, number of dosage 
units, and date of release. Under Sec.  600.90, a licensed manufacturer 
may submit a waiver request for any requirements that applies to the 
licensed manufacturer under Sec.  600.80 and 600.81. A waiver request 
submitted under Sec.  600.90 must include supporting documentation.
    Manufacturers of biological products for human use must keep 
records of each step in the manufacture and distribution of a product 
including any recalls. These recordkeeping requirements serve 
preventative and remedial purposes by establishing accountability and 
traceability in the manufacture and distribution of products. These 
requirements also enable FDA to perform meaningful inspections.
    Section 600.12 requires, among other things, concurrently with the 
performance of each step that all records of each step in the 
manufacture and distribution of a product be made and retained for no 
less than 5 years after the records of manufacture have been completed 
or 6 months after the latest expiration date for the individual 
product, whichever represents a later date. In addition, manufacturers 
must maintain records of sterilization of equipment and supplies, 
animal necropsy records, and records in cases of divided manufacturing 
of a product. Section 600.12(b)(2) requires manufacturers to maintain 
complete records pertaining to the recall from distribution of any 
product.
    Respondents to this collection of information are manufacturers of 
biological products. Under table 1 of this document, the number of 
respondents is based on the estimated number of manufacturers that 
submitted the required information to the Center for Biologics 
Evaluation and Research and Center for Drug Evaluation and Research, 
FDA, in fiscal year (FY) 2006. Based on information obtained from FDA's 
database system, there were 88 licensed biologics manufacturers. This 
number excludes those manufacturers who produce blood and blood 
components and in-vitro diagnostic licensed products, because Sec.  
600.80(k) specifically exempts manufacturers of these products from 
adverse experience reporting requirements. The total annual responses 
are based on the estimated number of submissions received annually by 
FDA in FY 2006. However, not all manufacturers have submissions in a 
given year and some may have multiple submissions. There were an 
estimated 23,835 15-day Alert reports, 21,872 periodic reports, and 179 
lot distribution reports submitted to FDA. The number of 15-day Alert 
reports for postmarketing studies under Sec.  600.80(e) is included in 
the total number of 15-day Alert reports. FDA received 6 requests for 
waiver under Sec.  600.90, all of which were granted. The hours per 
response are based on FDA experience. The burden hours required to 
complete the MedWatch Form for Sec.  600.80(c)(1), (e), and (f) are 
reported under OMB control no. 0910-0291.
    In the Federal Register of February 15, 2008 (73 FR 8881), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
600.80(c)(1)                   88                270.85             23,835                  1             23,835
 and 600.80(e)
----------------------------------------------------------------------------------------------------------------
600.80(c)(2)                   88                248.55             21,872                 28            612,416
----------------------------------------------------------------------------------------------------------------
600.81                         88                  2.03                179                  1                179
----------------------------------------------------------------------------------------------------------------
600.90                          6                  1                     6                  1                  6
----------------------------------------------------------------------------------------------------------------
Total                                                                                                    636,436
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Under table 2 of this document, the number of respondents is based 
on the number of manufacturers subject to those regulations. Based on 
information obtained from FDA's database system, there were 303 
licensed manufacturers of biological products in FY 2006. However, the 
number of recordkeepers listed for Sec.  600.12(a) through (e) 
excluding (b)(2) is estimated to be 112. This number excludes 
manufacturers of blood and blood components because their burden hours 
for recordkeeping have been reported under 21 CFR 606.160 in OMB 
control no. 0910-0116. The total annual records is based on the annual 
average of lots released (5,291), number of recalls made (1,841), and 
total number of adverse experience reports received (45,707) in FY 
2006. The hours per record are based on FDA experience.
    FDA estimates the burden of this recordkeeping as follows:

[[Page 28488]]



                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                      No. Of         Annual Frequency       Total Annual
21 CFR Section    Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
----------------------------------------------------------------------------------------------------------------
600.12                        112                 47.24              5,291                 32            169,312
----------------------------------------------------------------------------------------------------------------
600.12(b)(2)                  303                  6.08              1,841                 24             44,184
----------------------------------------------------------------------------------------------------------------
600.80(i)                      88                519.40             45,707                  1             45,707
----------------------------------------------------------------------------------------------------------------
Total                                                                                                    259,203
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: May 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-11057 Filed 5-15-08; 8:45 am]
BILLING CODE 4160-01-S