Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees, 77403-77405 [E5-8115]

Download as PDF Federal Register / Vol. 70, No. 250 / Friday, December 30, 2005 / Notices 77403 DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES collection of information to OMB for review and clearance. Food and Drug Administration Food and Drug Administration [Docket No. 2005N–0178] [Docket No. 2001D–0489] (formerly Docket No. 01D–0489) Draft Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees The draft guidance document, when finalized, is intended to assist sponsors of clinical trials in determining when a Data Monitoring Committee (DMC) is needed for study monitoring, and how such committees should operate. The draft guidance was revised based on public comments. The draft guidance addresses the roles, responsibilities, and operating procedures of DMCs, and describes certain reporting and recordkeeping responsibilities including the following: (1) Sponsor notification to the DMC regarding waivers of expedited reporting, (2) DMC reports of meeting minutes to the sponsor, (3) sponsor reporting to FDA on DMC safety-related recommendations, (4) standard operating procedures (SOPs) for DMCs, (5) DMC meeting records, and (6) DMC reports to the sponsor. Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Regulations Under the Federal Import Milk Act AGENCY: Food and Drug Administration, HHS. ACTION: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees AGENCY: Notice. Food and Drug Administration, HHS. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Regulations Under the Federal Import Milk Act’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–4659. In the Federal Register of October 7, 2005 (70 FR 58709), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0212. The approval expires on December 31, 2008. A copy of the supporting statement for this information collection is available on the Internet at http://www.fda.gov/ ohrms/dockets. SUPPLEMENTARY INFORMATION: Dated: December 22, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E5–8114 Filed 12–29–05; 8:45 am] BILLING CODE 4160–01–S 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 January 30, 2005. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: 202–395–6974. Submit written requests for single copies of the draft guidance dated December 2005 to the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1–800–835– 4709 or 301–827–1800. Persons with access to the Internet may obtain the draft guidance at either http:// www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/ default.htm. wwhite on PROD1PC61 with NOTICES FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (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 VerDate Aug<31>2005 18:16 Dec 29, 2005 Jkt 208001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 A. Sponsor Notification to the DMC Regarding Waivers The sponsor has the responsibility of reporting to FDA serious, unexpected adverse events in drugs and biologics trials under part 312 (21 CFR part 312) in § 312.32 and unanticipated adverse events in the case of device trials under part 812 (21 CFR part 812) in § 812.150(b)(1). We recommend in the draft guidance that sponsors notify DMCs about any waivers granted by FDA for expedited reporting of certain serious events. B. DMC Report of Meeting Minutes to the Sponsor FDA recommends in the draft guidance that the DMC issue a written report to the sponsor based on the meeting minutes. Reports to the sponsor should include only those data generally available to the sponsor. The sponsor may convey the relevant information in this report to other interested parties such as study investigators. Meeting minutes or other information that include discussion of confidential data would not be provided to the sponsor. C. Sponsor reporting to FDA on DMC Safety-Related Recommendations The requirement of the sponsor to report DMC recommendations related to serious adverse events in an expedited manner in clinical trials of new drugs (§ 312.32(c)) would not apply when the DMC recommendation is related to an excess of events not classifiable as E:\FR\FM\30DEN1.SGM 30DEN1 77404 Federal Register / Vol. 70, No. 250 / Friday, December 30, 2005 / Notices serious. Nevertheless, we recommend in the draft guidance that sponsors inform FDA about all recommendations related to the safety of the investigational product whether or not the adverse event in question meets the definition of ‘‘serious.’’ D. Standard Operating Procedures In the draft guidance, FDA recommends that sponsors establish procedures to do the following things: • Assess potential conflicts of interest of proposed DMC members; • Ensure that those with serious conflicts of interest are not included on the DMC; • Provide disclosure to all DMC members of any potential conflicts that are not thought to impede objectivity and, thus, would not preclude service on the DMC; • Identify and disclose any concurrent service of any DMC member on other DMCs of the same, related or competing products; • Ensure separation, and designate a different statistician to advise on the management of the trial, if the primary study statistician takes on the responsibility for interim analysis and reporting to the DMC; and • Minimize the risks of bias that are associated with such arrangements, if the primary study statistician takes on the responsibility for interim analysis and reporting to the DMC, and it appears infeasible or highly impractical for any other statistician to take over responsibilities related to trial management. E. Meeting Records FDA recommends in the draft guidance that the DMC or the group preparing the interim reports to the DMC maintain all meeting records. This information should be submitted to FDA with the clinical study report (§ 314.50(d)(5)(ii) (21 CFR 314.50(d)(5)(ii))). Description of Respondents: The submission and data collection recommendations described in this document affect sponsors of clinical trials and DMCs. Burden Estimate: Table 1 of this document provides the burden estimate of the annual reporting burden for the information to be submitted in accordance with the revised draft guidance. Table 2 of this document provides the burden estimate of the annual recordkeeping burden for the information to be maintained in accordance with the revised draft guidance. Based on information from FDA review divisions, FDA estimates there are currently 740 clinical trials with DMCs regulated by CBER, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health. FDA estimates that the average length of a clinical trial is 2 years, resulting in an annual estimate of 370 clinical trials. Because FDA has no information on which to project a change in the use of DMCs, FDA estimates that the number of clinical trials with DMCs will not change significantly in the next few years. For purposes of this information collection, FDA estimates that each sponsor is responsible for approximately 10 trials, resulting in an estimated 37 sponsors affected by the guidance annually. Based on information provided to FDA by sponsors that have typically used DMCs for the kinds of studies for which this draft guidance recommends them, FDA estimates that the majority of sponsors have already prepared SOPs for DMCs, and only a minimum amount of time would be necessary to revise or update them for use for other clinical studies. FDA receives very few requests for waivers regarding expedited reporting of certain serious events, therefore, FDA has estimated one respondent per year to account for the rare instance a request may be made. FDA estimates that the DMCs would hold two meetings per year per clinical trial resulting in the issuance of two DMC reports of the meeting minutes to the sponsor. One set of both of the meeting records should be maintained per clinical trial. The ‘‘Hours per Response’’ and ‘‘Hours per Record’’ are based on FDA’s experience with comparable recordkeeping and reporting provisions applicable to FDA regulated industry. The ‘‘Hours per Response’’ include the time the respondent would spend reviewing, gathering, and preparing the information to be submitted to the DMC, FDA, or the sponsor. The ‘‘Hours per Record’’ include the time to record, gather, and maintain the information. In the Federal Register of November 20, 2001 (FR 66 58151), FDA published a 60-day notice requesting public comment on the information collection provisions in the draft guidance. FDA received a number of comments on the draft guidance, however, only one letter of comment included comments regarding the information collection provisions. The comment stated that the ‘‘Hours per Response’’ were underestimated for the SOPs and Data Analysis Plan (statistical approach) listed in table 1 of the 60-day notice (66 FR 58151 at 58153) for the ‘‘Estimated Annual Reporting Burden.’’ The comment requested an increase to 12 hours for these burdens from the previous estimate of 4 hours for the SOPs, and 8 hours for the Data Analysis Plan. In revising the draft guidance, FDA is adding the applicable regulations throughout the draft guidance including the regulations associated with these two burden estimates. The burden associated with the submission of SOPs and the statistical approach in table 1 of the 60-day notice is covered under §§ 312.23 and 812.150(b)(10) and is approved under OMB Control Nos. 0910–0014 and 0910–0078. Therefore, these categories were removed from table 1 and no change in the burden estimates is necessary. Based on revisions to the draft guidance, however, two additional information collection burdens have been added to table 1 of this document, and one additional previous information collection burden was deleted from table 1 of the 60-day notice. The information collection provisions in the draft guidance for §§ 312.30, 312.32, 312.38, 312.55, and 312.56 have been approved under OMB Control No. 0910–0014; § 314.50 has been approved under OMB Control No. 0910–0001; and §§ 812.35 and 812.150 have been approved under OMB Control No. 0190– 0078. The total estimated burden for both the reporting and recordkeeping burdens under the draft guidance are 1,794.75 hours. wwhite on PROD1PC61 with NOTICES TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Section of Draft Guidance/ Reporting Activity No. of Respondents 4.4.1.2 Sponsor notification to the DMC regarding waivers of expedited reporting VerDate Aug<31>2005 18:16 Dec 29, 2005 Jkt 208001 Annual Frequency per Response 1 PO 00000 Frm 00033 Total Annual Responses 1 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM Hours per Response 1 Total Hours .25 30DEN1 .25 77405 Federal Register / Vol. 70, No. 250 / Friday, December 30, 2005 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued Section of Draft Guidance/ Reporting Activity No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 4.4.3.2 DMC reports of meeting minutes to the sponsor 370 2 740 1 740 5 Sponsor reporting to FDA on DMC safety-related recommendations 37 1 37 .5 18.5 Total 1 There 758.75 are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1 No. of Recordkeepers Reporting Activity Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 4.1 and 6.4 SOPs for DMCs 37 1 37 8 296 4.4.3.2 DMC meeting records 370 1 370 2 740 Total 1 There 1,036 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: December 22, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E5–8115 Filed 12–29–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Privacy Act System of Records AGENCY: Indian Health Service (IHS), HHS. Amendment of one altered Privacy Act system of records. ACTION: SUMMARY: Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a system of records, System No. 09–17–0001, ‘‘Medical, Health and Billing Records.’’ The amended and altered system of records makes only administrative edits and revisions as necessary. The amended and altered system, which incorporates the comments received following the initial publication, shall become effective December 30, 2005. FOR FURTHER INFORMATION: Contact Ms. Patricia Gowan, IHS Lead Health Information Management (HIM) Consultant (Acting), Office of Health Programs, Phoenix Area Office IHS, Two Renaissance Square, Suite 606, 40 North Central Avenue, Phoenix, AZ 85004 or via the Internet at Patricia.Gowan@ihs.gov. wwhite on PROD1PC61 with NOTICES DATES: VerDate Aug<31>2005 18:16 Dec 29, 2005 Jkt 208001 As required by the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), this document sets forth the amendment of the proposed alteration of a system of records maintained by the IHS, in response to comments received following the initial publication in the Federal Register at 70 FR 49931 on August 25, 2005. The purpose of altering System No. 09–17–0001, ‘‘Health and Medical Records,’’ is to enable the IHS to clarify that IHS also uses the records in the system to process, document, and monitor thirdparty payment billing and reimbursement claims, in addition to debt collection activities; to include contract health service records; to include several new and modified purposes and new and modified routine uses that are in line with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule provisions and Agency policy changes. IHS published the notification of the altered Privacy Act system of records in the Federal Register on August 25, 2005. During the comment period, IHS received several responses from the public. After a careful review of their concerns, IHS does not agree with the suggested changes and therefore has not revised the notice. One of the commentors suggested revising routine use #10 so that it would provide an exception that would enable IHS to disclose patient health information for public health purposes. IHS has decided not to accept the recommendation of this comment because the IHS already complies with state laws that specifically require disclosures of health SUPPLEMENTARY INFORMATION: PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 information for public health activities under the current routine use #7. In addition, the proposed routine use #10 modifies and replaces the current routine use #7 to allow disclosures ‘‘as authorized by law’’ which is a broader standard than the current ‘‘as required by law’’ standard. In fact, the particular example submitted by the commentor in support of the recommendation does not meet the public health authority and activities criteria of the HIPAA Privacy Rule. The Nevada State Pharmacy Board is not a public health authority and reporting such information to a state database appears to be primarily for law enforcement purposes. The Nevada statute also does not specifically require IHS or other Federal agencies to report to their database. Another comment stated that ‘‘IHS consider changing the permissive word ‘‘may’’ to the mandatory word ‘‘shall’’ in regards to the proposed Routine Use Number 23.’’ In response to the comment, IHS has decided to reject the comment based on the fact that routine use disclosures are not mandatory but are discretionary disclosures made by the appropriate IHS Privacy Act System Manager for which is defined in the Privacy Act of 1974, as amended, 5 U.S.C. 552a; and the OMB Privacy Act Implementation Guidelines and Responsibilities of July 9, 1975. The revision or modification of various IHS and Federal Records addresses in Appendix 1 and Appendix 2 is necessary to this system of records as administrative edits or changes. In Appendix 1, the address for the Fort McDermitt Clinic under the Phoenix Area IHS was inadvertently omitted; E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 70, Number 250 (Friday, December 30, 2005)]
[Notices]
[Pages 77403-77405]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-8115]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2001D-0489] (formerly Docket No. 01D-0489)


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Draft Guidance for 
Clinical Trial Sponsors: Establishment and Operation of Clinical Trial 
Data Monitoring Committees

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 January 
30, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
    Submit written requests for single copies of the draft guidance 
dated December 2005 to the Office of Communication, Training, and 
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and 
Research (CBER), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist the office in processing your requests. The draft guidance may 
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/
ohrms/dockets/default.htm.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management 
Programs (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.

Draft Guidance for Clinical Trial Sponsors: Establishment and Operation 
of Clinical Trial Data Monitoring Committees

    The draft guidance document, when finalized, is intended to assist 
sponsors of clinical trials in determining when a Data Monitoring 
Committee (DMC) is needed for study monitoring, and how such committees 
should operate. The draft guidance was revised based on public 
comments. The draft guidance addresses the roles, responsibilities, and 
operating procedures of DMCs, and describes certain reporting and 
recordkeeping responsibilities including the following: (1) Sponsor 
notification to the DMC regarding waivers of expedited reporting, (2) 
DMC reports of meeting minutes to the sponsor, (3) sponsor reporting to 
FDA on DMC safety-related recommendations, (4) standard operating 
procedures (SOPs) for DMCs, (5) DMC meeting records, and (6) DMC 
reports to the sponsor.

A. Sponsor Notification to the DMC Regarding Waivers

    The sponsor has the responsibility of reporting to FDA serious, 
unexpected adverse events in drugs and biologics trials under part 312 
(21 CFR part 312) in Sec.  312.32 and unanticipated adverse events in 
the case of device trials under part 812 (21 CFR part 812) in Sec.  
812.150(b)(1). We recommend in the draft guidance that sponsors notify 
DMCs about any waivers granted by FDA for expedited reporting of 
certain serious events.

B. DMC Report of Meeting Minutes to the Sponsor

    FDA recommends in the draft guidance that the DMC issue a written 
report to the sponsor based on the meeting minutes. Reports to the 
sponsor should include only those data generally available to the 
sponsor. The sponsor may convey the relevant information in this report 
to other interested parties such as study investigators. Meeting 
minutes or other information that include discussion of confidential 
data would not be provided to the sponsor.

C. Sponsor reporting to FDA on DMC Safety-Related Recommendations

    The requirement of the sponsor to report DMC recommendations 
related to serious adverse events in an expedited manner in clinical 
trials of new drugs (Sec.  312.32(c)) would not apply when the DMC 
recommendation is related to an excess of events not classifiable as

[[Page 77404]]

serious. Nevertheless, we recommend in the draft guidance that sponsors 
inform FDA about all recommendations related to the safety of the 
investigational product whether or not the adverse event in question 
meets the definition of ``serious.''

D. Standard Operating Procedures

    In the draft guidance, FDA recommends that sponsors establish 
procedures to do the following things:
     Assess potential conflicts of interest of proposed DMC 
members;
     Ensure that those with serious conflicts of interest are 
not included on the DMC;
     Provide disclosure to all DMC members of any potential 
conflicts that are not thought to impede objectivity and, thus, would 
not preclude service on the DMC;
     Identify and disclose any concurrent service of any DMC 
member on other DMCs of the same, related or competing products;
     Ensure separation, and designate a different statistician 
to advise on the management of the trial, if the primary study 
statistician takes on the responsibility for interim analysis and 
reporting to the DMC; and
     Minimize the risks of bias that are associated with such 
arrangements, if the primary study statistician takes on the 
responsibility for interim analysis and reporting to the DMC, and it 
appears infeasible or highly impractical for any other statistician to 
take over responsibilities related to trial management.

E. Meeting Records

    FDA recommends in the draft guidance that the DMC or the group 
preparing the interim reports to the DMC maintain all meeting records. 
This information should be submitted to FDA with the clinical study 
report (Sec.  314.50(d)(5)(ii) (21 CFR 314.50(d)(5)(ii))).
    Description of Respondents: The submission and data collection 
recommendations described in this document affect sponsors of clinical 
trials and DMCs.
    Burden Estimate: Table 1 of this document provides the burden 
estimate of the annual reporting burden for the information to be 
submitted in accordance with the revised draft guidance. Table 2 of 
this document provides the burden estimate of the annual recordkeeping 
burden for the information to be maintained in accordance with the 
revised draft guidance.
    Based on information from FDA review divisions, FDA estimates there 
are currently 740 clinical trials with DMCs regulated by CBER, the 
Center for Drug Evaluation and Research, and the Center for Devices and 
Radiological Health. FDA estimates that the average length of a 
clinical trial is 2 years, resulting in an annual estimate of 370 
clinical trials. Because FDA has no information on which to project a 
change in the use of DMCs, FDA estimates that the number of clinical 
trials with DMCs will not change significantly in the next few years. 
For purposes of this information collection, FDA estimates that each 
sponsor is responsible for approximately 10 trials, resulting in an 
estimated 37 sponsors affected by the guidance annually.
    Based on information provided to FDA by sponsors that have 
typically used DMCs for the kinds of studies for which this draft 
guidance recommends them, FDA estimates that the majority of sponsors 
have already prepared SOPs for DMCs, and only a minimum amount of time 
would be necessary to revise or update them for use for other clinical 
studies. FDA receives very few requests for waivers regarding expedited 
reporting of certain serious events, therefore, FDA has estimated one 
respondent per year to account for the rare instance a request may be 
made. FDA estimates that the DMCs would hold two meetings per year per 
clinical trial resulting in the issuance of two DMC reports of the 
meeting minutes to the sponsor. One set of both of the meeting records 
should be maintained per clinical trial.
    The ``Hours per Response'' and ``Hours per Record'' are based on 
FDA's experience with comparable recordkeeping and reporting provisions 
applicable to FDA regulated industry. The ``Hours per Response'' 
include the time the respondent would spend reviewing, gathering, and 
preparing the information to be submitted to the DMC, FDA, or the 
sponsor. The ``Hours per Record'' include the time to record, gather, 
and maintain the information.
    In the Federal Register of November 20, 2001 (FR 66 58151), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions in the draft guidance. FDA received a number of 
comments on the draft guidance, however, only one letter of comment 
included comments regarding the information collection provisions.
    The comment stated that the ``Hours per Response'' were 
underestimated for the SOPs and Data Analysis Plan (statistical 
approach) listed in table 1 of the 60-day notice (66 FR 58151 at 58153) 
for the ``Estimated Annual Reporting Burden.'' The comment requested an 
increase to 12 hours for these burdens from the previous estimate of 4 
hours for the SOPs, and 8 hours for the Data Analysis Plan.
    In revising the draft guidance, FDA is adding the applicable 
regulations throughout the draft guidance including the regulations 
associated with these two burden estimates. The burden associated with 
the submission of SOPs and the statistical approach in table 1 of the 
60-day notice is covered under Sec. Sec.  312.23 and 812.150(b)(10) and 
is approved under OMB Control Nos. 0910-0014 and 0910-0078. Therefore, 
these categories were removed from table 1 and no change in the burden 
estimates is necessary.
    Based on revisions to the draft guidance, however, two additional 
information collection burdens have been added to table 1 of this 
document, and one additional previous information collection burden was 
deleted from table 1 of the 60-day notice.
    The information collection provisions in the draft guidance for 
Sec. Sec.  312.30, 312.32, 312.38, 312.55, and 312.56 have been 
approved under OMB Control No. 0910-0014; Sec.  314.50 has been 
approved under OMB Control No. 0910-0001; and Sec. Sec.  812.35 and 
812.150 have been approved under OMB Control No. 0190-0078.
    The total estimated burden for both the reporting and recordkeeping 
burdens under the draft guidance are 1,794.75 hours.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Section of Draft
    Guidance/           No. of         Annual Frequency       Total Annual        Hours per
    Reporting        Respondents         per Response          Responses          Response         Total Hours
    Activity
----------------------------------------------------------------------------------------------------------------
4.4.1.2 Sponsor                   1                     1                  1               .25               .25
 notification to
 the DMC
 regarding
 waivers of
 expedited
 reporting
-----------------

[[Page 77405]]

 
-----------------
-------------------------------------
Total                                                                                                     758.75
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
   Reporting          No. of         Annual Frequency       Total Annual
   Activity       Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
----------------------------------------------------------------------------------------------------------------
4.1 and 6.4                    37                     1                 37                  8                296
 SOPs for DMCs
---------------====================
-----------------------------------
Total                                                                                                      1,036
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: December 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-8115 Filed 12-29-05; 8:45 am]
BILLING CODE 4160-01-S