Updating the List of Hazardous Drugs for the NIOSH Alert: Additions and Deletions to the NIOSH Hazardous Drug List, 19570-19571 [E9-9779]

Download as PDF pwalker on PROD1PC71 with NOTICES 19570 Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Notices Medicaid program, a State health department, or the Drug Enforcement Administration must submit a written request to the State PMP that identifies the summary statistics sought. The requesting Department, program, administration, etc., must certify that the requested information is necessary for research to be conducted by such department, program, or administration, respectively, and the intended purpose of the research is related to a function committed to such department, program, or administration by law that is not investigative in nature. (e) An agent of the State agency or entity of another State that is responsible for the establishment and maintenance of the State’s controlled substance monitoring program must submit a written request on Agency letterhead that identifies the requestor as the person responsible for that State’s controlled substance monitoring program. After authentication by the disclosing State PMP, the requesting State certifies that (i) the State has an application approved under this section; and (ii) the requested information is for the purpose of implementing the State’s controlled substance monitoring program. Patients. The Administrator notes that NASPER does not specifically designate disclosures to patients as a category for minimum requirements, perhaps because HIPAA and other patient information access provisions already permit sufficient patient access to their own controlled prescription drug information. The Administrator invites specific comment on this issue. Unsolicited Disclosures of Information from PMPs. Practitioners and Dispensers. Under 42 U.S.C. 280g– 3(f)(2)(A), NASPER requires that ‘‘[I]n consultation with practitioners, dispensers, and other relevant and interested stakeholders, a State receiving a grant under subsection (a) * * * shall establish a program to notify practitioners and dispensers of information that will help identify and prevent the unlawful diversion or misuse of controlled substances * * *.’’ The Administrator understands that notifying prescribers and dispensers when PMP activity suggest drug diversion, or identifying individuals who may need substance abuse treatment, is important to reducing substance abuse and reducing illicit distribution of controlled prescription substances. In addition, the Administrator is aware that many States have established ‘‘thresholds’’ that trigger such notifications. States have considerable latitude in establishing such programs; and, at a minimum VerDate Nov<24>2008 17:48 Apr 28, 2009 Jkt 217001 States must establish and articulate the criteria for such thresholds. For example: The threshold for notifying prescribers and dispensers is when an individual has filled five or more controlled substance prescriptions from five different prescribers, or five different dispensers in the State, within a six month period. Drug Diversion Investigators—Under 42 U.S.C. 280g–3(f)(2)(B) a State PMP ‘‘may, to the extent permitted under State law, notify the appropriate authorities responsible for carrying out drug diversion investigations if the State determines that information in the database maintained by the State under subsection (e) indicates an unlawful diversion or abuse of a controlled substance.’’ The Administrator notes that the language in NASPER clearly indicates that the provision for PMP to notify law enforcement officials of potentially criminal violations is voluntary. It is likely that most States with existing PMPs have established procedures and thresholds for these types of unsolicited disclosures. The Administrator understands that minimum required thresholds and procedures would be quantitatively and qualitatively different from those proposed for practitioners and dispensers, above. At this time, the Administrator is not proposing minimum requirements for unsolicited disclosures to drug diversion investigators; however, the Administrator invites comment on this issue. Eric B. Broderick, Acting Administrator, Assistant Surgeon General, Substance Abuse and Mental Health Services Administration. [FR Doc. E9–9854 Filed 4–28–09; 8:45 am] BILLING CODE 4162–20–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket Number 105–A] Updating the List of Hazardous Drugs for the NIOSH Alert: Additions and Deletions to the NIOSH Hazardous Drug List AGENCY: National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of draft document available for public comment. PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 SUMMARY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document available for public comment entitled ‘‘Updating the List of Hazardous Drugs for the NIOSH Alert: Additions and Deletions to the NIOSH Hazardous Drug List.’’ The document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/review/ public/105a/. DATES: Comments must be postmarked by June 30, 2009. ADDRESSES: You may submit comments to nioshdocket@cdc.gov or to the NIOSH Docket Office, Robert A. Taft Laboratories, MS–C34, 4676 Columbia Parkway, Cincinnati, OH 45226 or by facsimile (513) 533–8285. Comments should be in Microsoft Word format and should reference NIOSH docket number 105–A. NIOSH includes all comments received without change in the docket, including any personal information provided. After the comment period has closed, comments will be able to be accessed electronically at https:// www.cdc.gov/NIOSH under the link to the NIOSH docket. As appropriate, NIOSH will post comments with the commenters’ names, affiliations and other information, on the Internet. Background: The ‘‘NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings’’ was published in September 2004 (https:// www.cdc.gov/niosh/docs/2004–165/). Since that time, approximately 60 new drugs have received FDA approval and approximately 60 drugs have received special warnings (usually black box warnings) based on reported adverse effects in patients. An additional 18 drugs were included from the updated National Institutes of Health (NIH) Hazardous Drug List. From this list of approximately 150 drugs, 62 drugs were determined to have one or more characteristic of a hazardous drug and published for comment in NIOSH docket number 105. After review by experts, public review and comment, input from stakeholders and review of the scientific literature, NIOSH has proposed a second draft list of hazardous drugs. A number of drugs were removed from the initial proposed list based on comments from the various groups and organizations. The second draft list identifies 24 drugs that fit the NIOSH definition of hazardous drugs. Based on comments received by NIOSH, Bacillus Calmette-Guerin (BCG) will be removed from Appendix A in the 2004 E:\FR\FM\29APN1.SGM 29APN1 Federal Register / Vol. 74, No. 81 / Wednesday, April 29, 2009 / Notices NIOSH Alert on Hazardous Drugs (https:// www.cdc.gov/niosh/docs/2004–165/) due to potential adverse effects in some patients from cross-contamination. This guidance document does not have the force and effect of law. FOR FURTHER INFORMATION CONTACT: Barbara MacKenzie, NIOSH, Robert A. Taft Laboratories, MS–C26, 4676 Columbia Parkway, Cincinnati, OH 45226, telephone (513) 533–8132, Email: hazardousdrugs@cdc.gov. Reference: https://www.cdc.gov/niosh/ docs/2004–102/. Web address for this document: https://www.cdc.gov/niosh/ review/public/105a/. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Room 111, Cincinnati, Ohio, 45226, telephone (513) 533–8303. Dated: April 22, 2009. Christine M. Branche, Acting Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. E9–9779 Filed 4–28–09; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HOMELAND SECURITY U.S. Immigration and Customs Enforcement Agency Information Collection Activities: New Information Collection; Comment Request pwalker on PROD1PC71 with NOTICES ACTION: 30-Day Notice of Information Collection Under Review; Form I–312, Designation of Attorney in Fact. The Department of Homeland Security, U.S. Immigration and Customs Enforcement (USICE), has submitted the following information collection request for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the Federal Register on February 12, 2009 Vol. 74 No. 28 7072, allowing for a 60-day public comment period. No comments were received on this information collection. The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted for thirty days May 29, 2009. Written comments and suggestions from the public and affected agencies regarding items contained in this notice and especially with regard to the estimated public burden and associated response time should be VerDate Nov<24>2008 17:48 Apr 28, 2009 Jkt 217001 directed to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to OMB Desk Officer, for United States Immigration and Customs Enforcement, Department of Homeland Security, and sent via electronic mail to oira_submission@omb.eop.gov or faxed to (202) 395–6974. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information should address one or more of the following four points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection (1) Type of Information Collection: New information collection. (2) Title of the Form/Collection: Designation of Attorney in Fact. (3) Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection: Form I–312. U.S. Immigration and Customs Enforcement. (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or Households. The I–312 is the instrument the U.S. Immigration and Customs Enforcement (ICE) uses to provide immigration bond obligors a means to designate an attorney to accept on the obligor’s behalf, the return of cash or United States bonds or notes deposited to secure an immigration bond upon the cancellation of the bond or the performance of the obligor. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: 12,500 responses at 30 minutes (.50 hours) per response. PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 19571 (6) An estimate of the total public burden (in hours) associated with the collection: 6,250 annual burden hours. Requests for a copy of the proposed information collection instrument, with instructions; or inquiries for additional information should be directed to: Joseph M. Gerhart, Chief, Records Management Branch; U.S. Immigration and Customs Enforcement, 500 12th Street, SW., Room 3138, Washington, DC 20536; (202) 732–6337. Dated: April 22, 2009. Lee Shirkey, Acting Chief, Records Management Branch, U.S. Immigration and Customs Enforcement, Department of Homeland Security. [FR Doc. E9–9720 Filed 4–28–09; 8:45 am] BILLING CODE 9111–28–P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: National Interest Waivers; Supplemental Evidence to I–140 and I– 485, Extension of a Currently Approved Information Collection; Comment Request ACTION: 30–Day Notice of Information Collection Under Review: National Interest Waivers; Supplemental Evidence to I–140 and I–485; OMB Control No. 1615–0063. The Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the Federal Register on February 11, 2009, at 74 FR 6915, allowing for a 60-day public comment period. USCIS did not receive any comments for this information collection. The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until May 29, 2009. This process is conducted in accordance with 5 CFR 1320.10. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), and to the Office of Information and Regulatory Affairs, Office of E:\FR\FM\29APN1.SGM 29APN1

Agencies

[Federal Register Volume 74, Number 81 (Wednesday, April 29, 2009)]
[Notices]
[Pages 19570-19571]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9779]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket Number 105-A]


Updating the List of Hazardous Drugs for the NIOSH Alert: 
Additions and Deletions to the NIOSH Hazardous Drug List

AGENCY: National Institute for Occupational Safety and Health (NIOSH) 
of the Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice of draft document available for public comment.

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

SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) of the Centers for Disease Control and Prevention (CDC) 
announces the availability of the following draft document available 
for public comment entitled ``Updating the List of Hazardous Drugs for 
the NIOSH Alert: Additions and Deletions to the NIOSH Hazardous Drug 
List.'' The document and instructions for submitting comments can be 
found at https://www.cdc.gov/niosh/review/public/105a/.

DATES: Comments must be postmarked by June 30, 2009.

ADDRESSES: You may submit comments to nioshdocket@cdc.gov or to the 
NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia 
Parkway, Cincinnati, OH 45226 or by facsimile (513) 533-8285. Comments 
should be in Microsoft Word format and should reference NIOSH docket 
number 105-A. NIOSH includes all comments received without change in 
the docket, including any personal information provided. After the 
comment period has closed, comments will be able to be accessed 
electronically at https://www.cdc.gov/NIOSH under the link to the NIOSH 
docket. As appropriate, NIOSH will post comments with the commenters' 
names, affiliations and other information, on the Internet.
    Background: The ``NIOSH Alert: Preventing Occupational Exposures to 
Antineoplastic and Other Hazardous Drugs in Health Care Settings'' was 
published in September 2004 (https://www.cdc.gov/niosh/docs/2004-165/). 
Since that time, approximately 60 new drugs have received FDA approval 
and approximately 60 drugs have received special warnings (usually 
black box warnings) based on reported adverse effects in patients. An 
additional 18 drugs were included from the updated National Institutes 
of Health (NIH) Hazardous Drug List. From this list of approximately 
150 drugs, 62 drugs were determined to have one or more characteristic 
of a hazardous drug and published for comment in NIOSH docket number 
105.
    After review by experts, public review and comment, input from 
stakeholders and review of the scientific literature, NIOSH has 
proposed a second draft list of hazardous drugs. A number of drugs were 
removed from the initial proposed list based on comments from the 
various groups and organizations. The second draft list identifies 24 
drugs that fit the NIOSH definition of hazardous drugs. Based on 
comments received by NIOSH, Bacillus Calmette-Guerin (BCG) will be 
removed from Appendix A in the 2004

[[Page 19571]]

NIOSH Alert on Hazardous Drugs (https://www.cdc.gov/niosh/docs/2004-165/) due to potential adverse effects in some patients from cross-
contamination.
    This guidance document does not have the force and effect of law.

FOR FURTHER INFORMATION CONTACT: Barbara MacKenzie, NIOSH, Robert A. 
Taft Laboratories, MS-C26, 4676 Columbia Parkway, Cincinnati, OH 45226, 
telephone (513) 533-8132, E-mail: hazardousdrugs@cdc.gov.
    Reference: https://www.cdc.gov/niosh/docs/2004-102/. Web address for 
this document: https://www.cdc.gov/niosh/review/public/105a/. All 
information received in response to this notice will be available for 
public examination and copying at the NIOSH Docket Office, 4676 
Columbia Parkway, Room 111, Cincinnati, Ohio, 45226, telephone (513) 
533-8303.

    Dated: April 22, 2009.
Christine M. Branche,
Acting Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. E9-9779 Filed 4-28-09; 8:45 am]
BILLING CODE 4163-19-P
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