Proposed Data Collections Submitted for Public Comment and Recommendations, 29754-29755 [2011-12571]

Download as PDF 29754 Federal Register / Vol. 76, No. 99 / Monday, May 23, 2011 / Notices References ICCVAM. 2008a. ICCVAM–NICEATM/ ECVAM Scientific Workshop on Alternative Methods to Refine, Reduce, or Replace the Mouse LD50 Assay for Botulinum Toxin Testing. NIH Publication No. 08–6416. Research Triangle Park, NC: NIEHS. Available: https://iccvam.niehs.nih.gov/docs/ biologics-docs/BoNTwkshprept.pdf. ICCVAM. 2008b. ICCVAM Test Method Evaluation Report: Validation Status of Five In Vitro Test Methods Proposed for Assessing Pyrogenicity of Pharmaceuticals and Other Products. NIH Publication No. 08– 6392. Research Triangle Park, NC: NIEHS. Available: https://iccvam.niehs.nih.gov/ methods/pyrogen/pyr_tmer.htm. Dated: May 16, 2011. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2011–12627 Filed 5–20–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60-Day–11–0576] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404–639–5960 and send comments to Daniel Holcomb, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Possession, Use, and Transfer of Select Agents and Toxins (OMB Control No. 0920–0576)—Revision—Office of Public Health Preparedness and Response (OPHPR), Division of Select Agents and Toxins, Centers for Disease Control and Prevention (CDC). Background and Brief Description The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Subtitle A of Public Law 107–188 (42 U.S.C. 262a), requires the United States Department of Health and Human Services (HHS) to regulate the possession, use, and transfer of biological agents or toxins (i.e., select agents and toxins) that could pose a severe threat to public health and safety. The Agricultural Bioterrorism Protection Act of 2002, Subtitle B of Public Law 107–188 (7 U.S.C. 8401), requires the United States Department of Agriculture (USDA) to regulate the possession, use, and transfer of biological agents or toxins (i.e., select agents and toxins) that could pose a severe threat to animal or plant health, or animal or plant products. In accordance with these Acts, HHS and USDA promulgated regulations requiring entities to register with the CDC or the Animal and Plant Health Inspection Service (APHIS) if they possess, use, or transfer a select agent or toxin (42 CFR part 73, 7 CFR part 331, and 9 CFR part 121). CDC is requesting continued OMB approval to collect this information through the use of five forms: (1) Application for Registration, (2) Request to Transfer Select Agent or Toxin, (3) Report of Theft, Loss, or Release of Select Agent and Toxin, (4) Report of Identification of Select Agent or Toxin, and (5) Request for Exemption. There have been no new select agent program forms added to this information collection request. The current versions of the standard forms have been revised to: (1) Reduce the burden expended by the regulated entities and CDC by removing similar questions, (2) enhance clarification of the transfer process, (3) determine the level of potential exposure, and (4) improve surveillance methods for monitoring the reports of select agents and toxins identified by registered entities. In addition to the standardized forms listed above, requests for expedited reviews, administrative reviews and inspections are also submitted to CDC. There is not a standardized form for the request for expedited review, administrative review and inspections. Therefore, an entity must submit a written request to the Secretary of Health and Human Services, by way of the Attorney General for expedited reviews (42 CFR 73.10(e)) and exclusions of an attenuated strain of a select agent or toxin that does not pose a severe threat to public health and safety (42 CFR 73.3(e)(1) and 73.4(e)(1)). Inspections take place prior to issuance of a certificate of registration to ensure compliance with regulation 42 CFR 73.18. Following the inspection an entity may be asked to respond to written requests and submits the documentation to CDC. Entities may also amend their registration (42 CFR, 73.7(h)(1)) if any changes occur to the information previously submitted. When applying for an amendment to a certificate of registration, an entity must obtain and complete the relevant portion of the application package. The total estimated annualized burden for all data collection is 8,878 hours. Information will be collected via fax, email and mail from respondents of the 320 entities registered with the Select Agent Program. There is no cost to the respondents other than their time. srobinson on DSK4SPTVN1PROD with NOTICES ESTIMATED ANNUALIZED BURDEN HOURS Form name 73.3(d) ............................................. 73.7(h)(1) ........................................ VerDate Mar<15>2010 16:22 May 20, 2011 Jkt 223001 PO 00000 Frm 00035 Average burden per response 5 320 1 8 4.5 1 23 2,560 320 Application for Registration ............ Amendment to Registration Application. Request to Transfer Select Agents or Toxins. 73.16 ............................................... Number of responses per respondent 1 1.5 480 Number of respondents CFR Fmt 4703 Sfmt 4703 E:\FR\FM\23MYN1.SGM 23MYN1 Total burden hours 29755 Federal Register / Vol. 76, No. 99 / Monday, May 23, 2011 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of respondents Number of responses per respondent Average burden per response Total burden hours CFR Form name 73.19(a)(b) ...................................... 180 1 1 180 320 9 1 2,880 73.5 & 73.6(d–e) ............................. 73.3 & 73.4(e)(1) ............................ 73.10(e) ........................................... 73.20 ............................................... 73.18 ............................................... Notification of Theft, Loss or Release. Report of Identification of Select Agent. Request of Exemption .................... Request for Exclusions/Restricted Request for Expedited Review ....... Administrative Review .................... Inspections ..................................... 3 71 1 30 320 1 1 1 1 1 1 1 1 4 8 3 71 1 120 2,560 Total ......................................... ......................................................... ........................ ........................ 73.5 & 73.6(a)(b) ............................ Dated: May 17, 2011. Daniel Holcomb, Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 2011–12571 Filed 5–20–11; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) srobinson on DSK4SPTVN1PROD with NOTICES In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC), announces the following meeting for the aforementioned committee: Time and Date 8 a.m.–6 p.m., June 22, 2011. 8 a.m.–4 p.m., June 23, 2011. Place: CDC, Tom Harkin Global Communications Center, 1600 Clifton Road, NE., Building 19, Kent ‘‘Oz’’ Nelson Auditorium, Atlanta, Georgia 30333. Status: Open to the public, limited only by the space available. Purpose: The committee is charged with advising the Director, CDC, on the appropriate uses of immunizing agents. In addition, under 42 U.S.C. 1396s, the committee is mandated to establish and periodically review and, as appropriate, revise the list of vaccines for administration to vaccine-eligible children through the Vaccines for Children (VFC) program, along with schedules regarding the appropriate periodicity, dosage, and contraindications applicable to the vaccines. Matters To Be Discussed: The agenda will include discussions on: human papillomavirus vaccines, pertussis, meningococcal vaccine, influenza, VerDate Mar<15>2010 16:22 May 20, 2011 Jkt 223001 febrile seizures related to vaccine administration, herpes zoster vaccine, 13-valent pneumococcal conjugate vaccine (PCV13), new MMR Vaccine Work Group, two dose varicella vaccination and hepatitis B vaccine. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Stephanie B. Thomas, National Center for Immunization and Respiratory Diseases, CDC, 1600 Clifton Road, NE., (E–05), Atlanta, Georgia 30333, Telephone: (404)639–8836, Fax: (404)639–8905, E-mail: acip@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention, and the Agency for Toxic Substances and Disease Registry. Dated: May 16, 2011. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2011–12563 Filed 5–20–11; 8:45 am] BILLING CODE 4160–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)—Ethics Subcommittee (ES) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned subcommittee: TIMES AND DATES: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 ............................ 8,878 1 p.m.–5 p.m., June 16, 2011 8:30 a.m.–12:30 p.m., June 17, 2011 PLACE: CDC, Thomas R. Harkin Global Communications Center, Distance Learning Auditorium, 1600 Clifton Road, NE., Atlanta, Georgia 30333. This meeting is also available by teleconference. Please dial (877) 928– 1204 and enter code 4305992. STATUS: Open to the public, limited only by the space available. The meeting room accommodates approximately 60 people. To accommodate public participation in the meeting, a conference telephone line will be available. The public is welcome to participate during the public comment. The public comment periods are tentatively scheduled from 4 p.m.–4:15 p.m. on June 16, 2011 and from 12 p.m.–12:15 p.m. on June 17, 2011. PURPOSE: The ES will provide counsel to the ACD, CDC, regarding a broad range of public health ethics questions and issues arising from programs, scientists and practitioners. MATTER TO BE DISCUSSED: Agenda items will include the following: An update on ES presentation during the April 28, 2011, ACD, CDC meeting; discussion of next steps on addressing potential public health ethical issues associated with implementation of effective preventive interventions for noncommunicable disease; and review of workgroup progress on developing practical tools to assist state, tribal, local, and territorial health departments in their efforts to address public health ethics challenges. The agenda is subject to change as priorities dictate. CONTACT PERSON FOR MORE INFORMATION: For security reasons, members of the public interested in attending the meeting should contact Drue Barrett, PhD, Designated Federal Officer, ACD, CDC–ES, 1600 Clifton Road, NE., M/S D–50, Atlanta, Georgia 30333. Telephone (404) 639–4690. E-mail: dbarrett@cdc.gov. The deadline for E:\FR\FM\23MYN1.SGM 23MYN1

Agencies

[Federal Register Volume 76, Number 99 (Monday, May 23, 2011)]
[Notices]
[Pages 29754-29755]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12571]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-11-0576]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-5960 
and send comments to Daniel Holcomb, CDC Acting Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
to omb@cdc.gov.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Possession, Use, and Transfer of Select Agents and Toxins (OMB 
Control No. 0920-0576)--Revision--Office of Public Health Preparedness 
and Response (OPHPR), Division of Select Agents and Toxins, Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002, Subtitle A of Public Law 107-188 (42 U.S.C. 
262a), requires the United States Department of Health and Human 
Services (HHS) to regulate the possession, use, and transfer of 
biological agents or toxins (i.e., select agents and toxins) that could 
pose a severe threat to public health and safety. The Agricultural 
Bioterrorism Protection Act of 2002, Subtitle B of Public Law 107-188 
(7 U.S.C. 8401), requires the United States Department of Agriculture 
(USDA) to regulate the possession, use, and transfer of biological 
agents or toxins (i.e., select agents and toxins) that could pose a 
severe threat to animal or plant health, or animal or plant products. 
In accordance with these Acts, HHS and USDA promulgated regulations 
requiring entities to register with the CDC or the Animal and Plant 
Health Inspection Service (APHIS) if they possess, use, or transfer a 
select agent or toxin (42 CFR part 73, 7 CFR part 331, and 9 CFR part 
121).
    CDC is requesting continued OMB approval to collect this 
information through the use of five forms: (1) Application for 
Registration, (2) Request to Transfer Select Agent or Toxin, (3) Report 
of Theft, Loss, or Release of Select Agent and Toxin, (4) Report of 
Identification of Select Agent or Toxin, and (5) Request for Exemption. 
There have been no new select agent program forms added to this 
information collection request. The current versions of the standard 
forms have been revised to: (1) Reduce the burden expended by the 
regulated entities and CDC by removing similar questions, (2) enhance 
clarification of the transfer process, (3) determine the level of 
potential exposure, and (4) improve surveillance methods for monitoring 
the reports of select agents and toxins identified by registered 
entities. In addition to the standardized forms listed above, requests 
for expedited reviews, administrative reviews and inspections are also 
submitted to CDC. There is not a standardized form for the request for 
expedited review, administrative review and inspections. Therefore, an 
entity must submit a written request to the Secretary of Health and 
Human Services, by way of the Attorney General for expedited reviews 
(42 CFR 73.10(e)) and exclusions of an attenuated strain of a select 
agent or toxin that does not pose a severe threat to public health and 
safety (42 CFR 73.3(e)(1) and 73.4(e)(1)). Inspections take place prior 
to issuance of a certificate of registration to ensure compliance with 
regulation 42 CFR 73.18. Following the inspection an entity may be 
asked to respond to written requests and submits the documentation to 
CDC.
    Entities may also amend their registration (42 CFR, 73.7(h)(1)) if 
any changes occur to the information previously submitted. When 
applying for an amendment to a certificate of registration, an entity 
must obtain and complete the relevant portion of the application 
package.
    The total estimated annualized burden for all data collection is 
8,878 hours. Information will be collected via fax, email and mail from 
respondents of the 320 entities registered with the Select Agent 
Program. There is no cost to the respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                   Number of
             CFR                  Form name        Number of     responses per   Average burden    Total burden
                                                  respondents     respondent      per response         hours
----------------------------------------------------------------------------------------------------------------
73.3(d)......................  Application for               5               1               4.5              23
                                Registration.
73.7(h)(1)...................  Amendment to                320               8               1             2,560
                                Registration
                                Application.
73.16........................  Request to                  320               1               1.5             480
                                Transfer
                                Select Agents
                                or Toxins.

[[Page 29755]]

 
73.19(a)(b)..................  Notification of             180               1               1               180
                                Theft, Loss or
                                Release.
73.5 & 73.6(a)(b)............  Report of                   320               9               1             2,880
                                Identification
                                of Select
                                Agent.
73.5 & 73.6(d-e).............  Request of                    3               1               1                 3
                                Exemption.
73.3 & 73.4(e)(1)............  Request for                  71               1               1                71
                                Exclusions/
                                Restricted.
73.10(e).....................  Request for                   1               1               1                 1
                                Expedited
                                Review.
73.20........................  Administrative               30               1               4               120
                                Review.
73.18........................  Inspections....             320               1               8             2,560
                              ----------------------------------------------------------------------------------
    Total....................  ...............  ..............  ..............  ................           8,878
----------------------------------------------------------------------------------------------------------------


    Dated: May 17, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-12571 Filed 5-20-11; 8:45 am]
BILLING CODE 4163-18-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.