Draft “Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials;” Availability, 22664-22665 [05-8634]

Download as PDF 22664 Federal Register / Vol. 70, No. 83 / Monday, May 2, 2005 / Notices other by written request to terminate or modify the agreement. [FR Doc. 05–8715 Filed 4–29–05; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Privacy Act of 1974, as amended; Computer Matching Program Office of Child Support Enforcement (OCSE), ACF, DHHS. ACTION: Notice of a computer matching program. AGENCY: SUMMARY: In compliance with the Privacy Act of 1974, as amended by Public Law 100–503, the Computer Matching and Privacy Protection Act of 1988, we are publishing a notice of a computer matching program that OCSE will conduct on behalf of itself and State Agencies administering Unemployment Compensation programs under Federal or State law to facilitate the administration of such programs. The match will utilize National Directory of New Hires (NDNH) records and State Unemployment Compensation (UC) records. DATES: OCSE will file a report of the subject matching program with the Committee on Homeland Security and Governmental Affairs of the Senate, the Committee on Government Reform and Oversight of the House of Representatives, and the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB). The matching program will be effective as indicated below. ADDRESSES: Interested parties may comment on this notice by writing to the Director, Division of Federal Systems, Office of Child Support Enforcement, Aerospace Building, 370 L’Enfant Promenade, SW., Washington, DC 20447. All comments received will be available for public inspection at this address. FOR FURTHER INFORMATION CONTACT: Director, Division of Federal Systems, Office of Child Support Enforcement, Aerospace Building, 370 L’Enfant Promenade, SW., Washington, DC 20447. Telephone Number (202) 401– 9271. SUPPLEMENTARY INFORMATION: The Privacy Act (5 U.S.C. 552a), as amended, provides for certain protections for individuals applying for and receiving Federal benefits. The law regulates the use of computer matching VerDate jul<14>2003 19:05 Apr 29, 2005 Jkt 205001 by Federal agencies when records in a system of records are matched with other Federal, state and local government records. The Privacy Act requires agencies involved in computer matching programs to: 1. Negotiate written agreements with the other agency or agencies participating in the matching programs; 2. Provide notification to applicants and beneficiaries that their records are subject to matching; 3. Verify match findings before reducing, suspending, or terminating an individual’s benefits or payments; 4. Furnish detailed reports to Congress and OMB; and 5. Establish a Data Integrity Board that must approve matching agreements. This Computer Match meets the requirements of 5 U.S.C. 552a. Dated: April 21, 2005. David H. Siegel, Acting Commissioner, Office of Child Support Enforcement. Notice of Computer Matching Program A. Participating Agencies 69 FR 31392 on June 3, 2004. The NDNH is maintained within the Location and Collection system of records. The matching program is a routine use under this system of records. State TANF programs will provide to OSCE electronic files containing the names and other personal identifying data of TANF recipients. Upon receipt of the electronic files of State TANF recipients, OSCE will perform a computer match against the NDNH. The NDNH database consists of Quarterly Wage, New Hire, and Unemployment Insurance information. The results of the matching program will be furnished by OSCE to State TANF programs. 1. The electronic files provided by State TANF programs will contain data elements of the recipient’s name and Social Security number (SSN). 2. OSCE will match the SSN on the State TANF file by computer against the NDNH database. Matching records, based on SSNs, will produce data elements of the individual’s name, SSN, home address, and employment information. To exchange personal data for purposes of identifying individuals who are employed and also are receiving payments pursuant to TANF benefit programs being administered by State TANF programs and to verify continuing eligibility for TANF benefits. OSCE will match public assistance records, furnished by State TANF programs, against information in the NDNH. After matching has been conducted, OSCE will provide match results to State TANF programs which will use this information to verify the continued eligibility of individuals to receive public assistance benefits and, if ineligible, to take such action, as may be authorized by law and regulation. E. Inclusive Dates of the Matching Program The effective date of the matching agreement and date when matching may actually begin shall be July 1, 2005. This Computer Matching Notice is being published in the Federal Register at least 30 days prior to that date, and at least 40 days prior to that date OSCE shall send a matching program notice to the Congressional committees of jurisdiction under 5 U.S.C. 552a(o)(2)(A); and to OMB. By agreement between ACF and State TANF programs, the matching program will be in effect for 18 months from the effective date, with an option to renew for 12 additional months, unless one of the parties to the agreement advises the other by written request to terminate or modify the agreement. C. Authority for Conducting the Match [FR Doc. 05–8730 Filed 4–29–05; 8:45 am] The authority for conducting the matching program is contained in section 453(j)(3) of the Social Security Act (42 U.S.C. 653(j)(3)). BILLING CODE 4184–01–M OSCE and State TANF programs. B. Purpose of the Matching program D. Categories of Records and Individuals Covered by the Matching Program The system of records maintained by the ACF under the privacy Act of 1974, as amended, 5 U.S.C. 552a, from which records will be disclosed for the purpose of this computer match, is the Location and Collection system of records, DHHS/OSCE No. 09–90–0074, last published in the Federal Register at PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0155] Draft ‘‘Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials;’’ Availability AGENCY: Food and Drug Administration, HHS. E:\FR\FM\02MYN1.SGM 02MYN1 Federal Register / Vol. 70, No. 83 / Monday, May 2, 2005 / Notices ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials,’’ dated April 2005. The draft guidance provides sponsors of vaccine trials with recommendations on assessing the severity of clinical and laboratory abnormalities in healthy adult and adolescent volunteers enrolled in clinical trials. In particular, the draft guidance includes toxicity grading scale tables to use as a guideline for selecting the assessment criteria. DATES: Submit written or electronic comments on the draft guidance by August 1, 2005 to ensure their adequate consideration in preparation of the final guidance. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance 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 the CBER Voice Information System at 1–800–835–4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Brenda R. Friend, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: SUMMARY: selecting the criteria to assess the severity of clinical and laboratory abnormalities in healthy adult and adolescent volunteers enrolled in clinical trials. The parameters in the tables are not necessarily warranted for every clinical trial of healthy volunteers. The parameters monitored should be appropriate for the specific study vaccine. In addition, the use of toxicity grading scales to categorize adverse events observed during clinical trials does not replace regulatory requirements to monitor, investigate, and report adverse events. The draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirement of the applicable statutes and regulations. II. Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the draft guidance. Submit written or electronic comments to ensure adequate consideration in preparation of the final guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in the brackets in the heading of this document. A copy of the draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access I. Background FDA is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials’’ dated April 2005. The draft guidance provides sponsors of vaccine trials with toxicity grading scale tables as a guideline for Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/cber/guidelines.htm or https://www.fda.gov/ohrms/dockets/ default.htm. Dated: April 22, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–8634 Filed 4–29–05; 8:45 am] VerDate jul<14>2003 19:05 Apr 29, 2005 Jkt 205001 BILLING CODE 4160–01–S PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 22665 DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. AGENCY: SUMMARY: The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory’s certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https://workplace.samhsa.gov and https://www.drugfreeworkplace.gov. FOR FURTHER INFORMATION CONTACT: Mrs. Giselle Hersh or Dr. Walter Vogl, Division of Workplace Programs, SAMHSA/CSAP, Room 2–1035, 1 Choke Cherry Road, Rockville, Maryland 20857; 240–276–2600 (voice), 240–276– 2610 (fax). SUPPLEMENTARY INFORMATION: The Mandatory Guidelines were developed in accordance with Executive Order 12564 and section 503 of Public Law 100–71. Subpart C of the Mandatory Guidelines, ‘‘Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies,’’ sets strict standards that laboratories must meet in order to conduct drug and specimen validity tests on urine specimens for Federal agencies. To become certified, an applicant laboratory must undergo three rounds of performance testing plus an on-site inspection. To maintain that E:\FR\FM\02MYN1.SGM 02MYN1

Agencies

[Federal Register Volume 70, Number 83 (Monday, May 2, 2005)]
[Notices]
[Pages 22664-22665]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8634]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0155]


Draft ``Guidance for Industry: Toxicity Grading Scale for Healthy 
Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical 
Trials;'' Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 22665]]


ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: 
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers 
Enrolled in Preventive Vaccine Clinical Trials,'' dated April 2005. The 
draft guidance provides sponsors of vaccine trials with recommendations 
on assessing the severity of clinical and laboratory abnormalities in 
healthy adult and adolescent volunteers enrolled in clinical trials. In 
particular, the draft guidance includes toxicity grading scale tables 
to use as a guideline for selecting the assessment criteria.

DATES: Submit written or electronic comments on the draft guidance by 
August 1, 2005 to ensure their adequate consideration in preparation of 
the final guidance. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance 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 the CBER Voice Information System at 1-800-
835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.
    Submit written comments on the draft guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to https://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Brenda R. Friend, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Toxicity Grading Scale for Healthy Adult and 
Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials'' 
dated April 2005. The draft guidance provides sponsors of vaccine 
trials with toxicity grading scale tables as a guideline for selecting 
the criteria to assess the severity of clinical and laboratory 
abnormalities in healthy adult and adolescent volunteers enrolled in 
clinical trials. The parameters in the tables are not necessarily 
warranted for every clinical trial of healthy volunteers. The 
parameters monitored should be appropriate for the specific study 
vaccine. In addition, the use of toxicity grading scales to categorize 
adverse events observed during clinical trials does not replace 
regulatory requirements to monitor, investigate, and report adverse 
events.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on this topic. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirement of the applicable 
statutes and regulations.

II. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding the draft guidance. Submit 
written or electronic comments to ensure adequate consideration in 
preparation of the final guidance. Submit a single copy of electronic 
comments or two paper copies of any mailed comments, except that 
individuals may submit one paper copy. Comments are to be identified 
with the docket number found in the brackets in the heading of this 
document. A copy of the draft guidance and received comments are 
available for public examination in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either https://www.fda.gov/cber/guidelines.htm or https://www.fda.gov/
ohrms/dockets/default.htm.

    Dated: April 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8634 Filed 4-29-05; 8:45 am]
BILLING CODE 4160-01-S

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