Agency Forms Undergoing Paperwork Reduction Act Review, 42091-42093 [2010-17685]

Download as PDF Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before July 22, 2010. Oral comments from the public will be scheduled between approximately 2 and 3 p.m. e.t. Time allotted for each presentation will be limited to three minutes each. If the number of speakers requesting to comment is greater than can be reasonably accommodated during the scheduled open public hearing session, ONC will take written comments after the meeting until close of business. Persons attending ONC’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. ONC welcomes the attendance of the public at its advisory committee meetings. Seating is limited at the location, and ONC will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Judy Sparrow at least seven (7) days in advance of the meeting. ONC is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://healthit.hhs.gov for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (Pub. L. 92–463, 5 USC. App. 2). Dated: July 6, 2010. Judith Sparrow, Office of Programs and Coordination, Office of the National Coordinator for Health Information Technology. [FR Doc. 2010–16950 Filed 7–19–10; 8:45 am] BILLING CODE 4150–45–P DEPARTMENT OF HEALTH AND HUMAN SERVICES wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 Office of the National Coordinator for Health Information Technology; HIT Policy Committee Advisory Meeting; Notice of Meeting AGENCY: Office of the National Coordinator for Health Information Technology, HHS. ACTION: Notice of meeting. This notice announces a forthcoming meeting of a public advisory committee of the Office of the National Coordinator for Health Information Technology (ONC). The meeting will be open to the public. Name of Committee: HIT Policy Committee. VerDate Mar<15>2010 15:23 Jul 19, 2010 Jkt 220001 General Function of the Committee: To provide recommendations to the National Coordinator on a policy framework for the development and adoption of a nationwide health information technology infrastructure that permits the electronic exchange and use of health information as is consistent with the Federal Health IT Strategic Plan and that includes recommendations on the areas in which standards, implementation specifications, and certification criteria are needed. Date and Time: The meeting will be held on July 21, 2010, from 9:30 a.m. to 4 p.m. e.t. Location: The Renaissance Washington, DC, Dupont Circle Hotel, 1143 New Hampshire Avenue, NW., Washington, DC, phone: 202–775–0800. Contact Person: Judy Sparrow, Office of the National Coordinator, HHS, 330 C Street, SW., Washington, DC 20201, 202–205–4528, fax: 202–690–6079, email: judy.sparrow@hhs.gov. Please call the contact person for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Agenda: The committee will hear reports from its workgroups, including the Meaningful Use Workgroup, the Certification/Adoption Workgroup, the Enrollment Workgroup, and the Privacy & Security Tiger Team. ONC intends to make background material available to the public no later than two (2) business days prior to the meeting. If ONC is unable to post the background material on its Web site prior to the meeting, it will be made publicly available at the location of the advisory committee meeting, and the background material will be posed on ONC’s Web site after the meeting, at https://healthit.hhs.gov. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before July 16, 2010. Oral comments from the public will be scheduled between approximately 3 p.m. to 4 p.m. Time allotted for each presentation is limited to three minutes. If the number of speakers requesting to comment is greater than can be reasonably accommodated during the scheduled open public hearing session, ONC will take written comments after the meeting until close of business. Persons attending ONC’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 42091 ONC welcomes the attendance of the public at its advisory committee meetings. Seating is limited at the location, and ONC will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Judy Sparrow at least seven (7) days in advance of the meeting. ONC is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://healthit.hhs.gov for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (Pub. L. 92–463, 5 U.S.C., App. 2). Dated: July 6, 2010. Judith Sparrow, Office of Programs and Coordination, Office of the National Coordinator for Health Information Technology. [FR Doc. 2010–16945 Filed 7–19–10; 8:45 am] BILLING CODE 4150–45–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30-Day–10–0639] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Proposed Project Special Exposure Cohort Petitions, (OMB Control Number 0920–0639, Expiration Date 07/31/2010)— Extension—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description On October 30, 2000, the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384–7385 [1994, supp. 2001] was enacted. It established E:\FR\FM\20JYN1.SGM 20JYN1 42092 Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices a compensation program to provide a lump sum payment of $150,000 and medical benefits as compensation to covered employees suffering from designated illnesses incurred as a result of their exposure to radiation, beryllium, or silica while in the performance of duty for the Department of Energy and certain of its vendors, contractors and subcontractors. This legislation also provided for payment of compensation for certain survivors of these covered employees. There is no change to the information collection. This program has been mandated to be in effect until Congress ends the funding. EEOICPA instructed the President to designate one or more Federal Agencies to carry out the compensation program. Accordingly, the President issued Executive Order 13179 (‘‘Providing Compensation to America’s Nuclear Weapons Workers’’) on December 7, 2000 (65 FR 77487), assigning primary responsibility for administration of the compensation program to the Department of Labor (DOL). The executive order directed the Department of Health and Human Services (HHS) to perform several technical and policymaking roles in support of the DOL program. Among other duties, the executive order directed HHS to establish and implement procedures for considering petitions by classes of nuclear weapons workers to be added to the ‘‘Special Exposure Cohort’’ (the ‘‘Cohort’’), various groups of workers whose claims for cancer under EEOICPA can be adjudicated without demonstrating that their cancer was ‘‘at least as likely as not’’ caused by radiation doses they incurred in the performance of duty. In brief, EEOICPA authorizes HHS to designate such classes of employees for addition to the Cohort when NIOSH lacks sufficient information to estimate with sufficient accuracy the radiation doses of the employees, if HHS also finds that the health of members of the class may have been endangered by the radiation dose the class potentially incurred. HHS must also obtain the advice of the Advisory Board on Radiation and Worker Health (the petitioner(s), obtain their contact information, and establish that the petitioner(s) is qualified and intends to petition HHS; (b) establish an initial definition of the class of employees being proposed to be considered for addition to the Cohort; (c) determine whether there is justification to require HHS to evaluate whether or not to designate the proposed class as an addition to the Cohort (such an evaluation involves potentially extensive data collection, analysis, and related deliberations by NIOSH, the Board, and HHS); and, (d) target an evaluation by HHS to examine relevant potential limitations of radiation monitoring and/or dosimetry-relevant records and to examine the potential for related radiation exposures that might have endangered the health of members of the class. Finally, under § 83.18, petitioners may contest the proposed decision of the Secretary to add or deny adding classes of employees to the cohort by submitting evidence that the proposed decision relies on a record of either factual or procedural errors in the implementation of these procedures. NIOSH estimates that the time to prepare and submit such a challenge is 45 minutes. Because of the uniqueness of this submission, NIOSH is not providing a form. There are no costs to petitioners unless a petitioner chooses to purchase the services of a expert in dose reconstruction, an option provided for under 42 CFR 83.9(c)(2)(iii). The petitioner would assume the financial burden of purchasing such services at their option. In such cases, HHS estimates a report by such an expert may cost between $640 and $6,400, depending on the scope of the petition and access to relevant information. This is based on an estimate of costs of $80 per hour for contractual services by a health physicist, who NIOSH estimates would be employed within a range of eight to eighty hours to conduct and prepare a report on the required assessment. The total estimated annual burden hours are 238. Board) in establishing such findings. On March 7, 2003, HHS proposed procedures for adding such classes to the Cohort in a notice of proposed rulemaking at 42 CFR Part 83. The HHS procedures authorize a variety of individuals and entities to submit petitions, as specified under § 83.7. Petitioners are required to provide the information specified in § 83.9 to qualify their petitions for a complete evaluation by HHS and the Board. HHS has developed two petition forms to assist the petitioners in providing this required information efficiently and completely, and an Authorization Form to permit a respondent to authorize another party to submit a petition on their behalf, as specified in § 83.7. Petition Form A is a one-page form to be used by EEOICPA claimants for whom NIOSH will have attempted to conduct dose reconstructions and will have determined that available information is not sufficient to complete the dose reconstruction. The form addresses the informational requirements specified under § 83.9(a) and (b). Petition Form B, accompanied by separate instructions, is intended for all other petitioners. The form addresses the informational requirements specified under § 83.9(a) and (c). Forms A and B can be submitted electronically as well as in hard copy. Petitioners should be aware that HHS is not requiring petitioners to use the forms. Petitioners can choose to submit petitions as letters or in other formats, but petitions must meet the informational requirements referenced above. NIOSH expects, however, that all petitioners for whom Form A would be appropriate will actually use the form, since NIOSH will provide it to them upon determining that their dose reconstruction cannot be completed and encourage them to submit the petition. NIOSH expects the large majority of petitioners for whom Form B would be appropriate will also use the form, since it provides a simple, organized format for addressing the informational requirements of a petition. NIOSH will use the information obtained through the petition for the following purposes: (a) Identify the wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 ESTIMATE OF ANNUALIZED BURDEN HOURS Form name & number (CFR reference) Form A 42 CFR 83.9 ...................................... Form B 42 CFR 83.9 ...................................... 42 CFR 83.9 ................................................... 42 CFR 83.18 ................................................. VerDate Mar<15>2010 15:23 Jul 19, 2010 Jkt 220001 No. of respondents Respondents Petitioners Petitioners Petitioners Petitioners PO 00000 using Form A ............................... using Form B ............................... not using Form B ......................... Appealing proposed decisions ..... Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\20JYN1.SGM 30 40 5 5 20JYN1 Average burden per respondent (in hours) No. of responses per respondent 1 1 1 1 3/60 5 6 45/60 42093 Federal Register / Vol. 75, No. 138 / Tuesday, July 20, 2010 / Notices ESTIMATE OF ANNUALIZED BURDEN HOURS—Continued No. of respondents Form name & number (CFR reference) Respondents Authorization Form 42 CFR 83.7 .................... Person authorizing a party to submit a petition on his/her behalf. Dated: July 13, 2010. Carol Walker, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. 2010–17685 Filed 7–19–10; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0367] Agency Information Collection Activities; Proposed Collection; Comment Request; Information Request Regarding Menthol in Cigarettes AGENCY: Food and Drug Administration, HHS. wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1 ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on an information request regarding the use of menthol in cigarettes. DATES: Submit either electronic or written comments on the collection of information by September 20, 2010. ADDRESSES: Submit electronic comments on the collection of information to https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management, Food and Drug VerDate Mar<15>2010 15:23 Jul 19, 2010 Jkt 220001 Administration, 1350 Piccard Dr. PI50– 400B, Rockville, MD 20850, 301–796– 3794, Jonnalynn.Capezzuto@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Information Request Regarding Menthol in Cigarettes—(OMB Control Number 0910–0662)—Extension On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) (Public Law 111–31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 20 Average burden per respondent (in hours) No. of responses per respondent 1 3/60 Act by adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. Section 917 of the Tobacco Control Act requires the Secretary of Health and Human Services (the Secretary) to establish a Tobacco Products Scientific Advisory Committee (TPSAC). Section 907(e) of the Tobacco Control Act requires the TPSAC to submit a report and recommendations to the Secretary on the impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities. To ensure a comprehensive review of this issue, the Center for Tobacco Products is requesting tobacco industry data and information to support the work of TPSAC. Under section 907(e) of the Tobacco Control Act, TPSAC must submit its report and recommendations to the Secretary within 1 year of its formation, or March 23, 2011. In order to provide TPSAC with the information it needs to carry out its statutory obligation, FDA is requesting that tobacco companies submit information under section 904(b) of the Tobacco Control Act. OMB granted emergency processing and approved the information collection on May 12, 2010. In a letter dated May 26, 2010, FDA asked tobacco manufacturers to submit documents containing scientific, marketing, and health-related information pertaining to the use of menthol in cigarettes. FDA has requested that tobacco manufacturers submit all documents and underlying scientific information relating to research activities, and research findings, conducted, supported, or possessed by the manufacturer (or agents thereof) on a specified set of topics. ‘‘Research activities’’ may include, but are not limited to, focus groups, surveys, experimental clinical studies, toxicological and biochemical assays, taste panels, and assessments of the effectiveness of product marketing practices. Scientific and health-related information FDA has requested include E:\FR\FM\20JYN1.SGM 20JYN1

Agencies

[Federal Register Volume 75, Number 138 (Tuesday, July 20, 2010)]
[Notices]
[Pages 42091-42093]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17685]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-10-0639]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-5960 or send an email to 
omb@cdc.gov. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC 20503 or by fax to (202) 395-
5806. Written comments should be received within 30 days of this 
notice.

Proposed Project

    Special Exposure Cohort Petitions, (OMB Control Number 0920-0639, 
Expiration Date 07/31/2010)--Extension--National Institute for 
Occupational Safety and Health (NIOSH), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    On October 30, 2000, the Energy Employees Occupational Illness 
Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384-7385 [1994, 
supp. 2001] was enacted. It established

[[Page 42092]]

a compensation program to provide a lump sum payment of $150,000 and 
medical benefits as compensation to covered employees suffering from 
designated illnesses incurred as a result of their exposure to 
radiation, beryllium, or silica while in the performance of duty for 
the Department of Energy and certain of its vendors, contractors and 
subcontractors. This legislation also provided for payment of 
compensation for certain survivors of these covered employees. There is 
no change to the information collection. This program has been mandated 
to be in effect until Congress ends the funding.
    EEOICPA instructed the President to designate one or more Federal 
Agencies to carry out the compensation program. Accordingly, the 
President issued Executive Order 13179 (``Providing Compensation to 
America's Nuclear Weapons Workers'') on December 7, 2000 (65 FR 77487), 
assigning primary responsibility for administration of the compensation 
program to the Department of Labor (DOL). The executive order directed 
the Department of Health and Human Services (HHS) to perform several 
technical and policymaking roles in support of the DOL program.
    Among other duties, the executive order directed HHS to establish 
and implement procedures for considering petitions by classes of 
nuclear weapons workers to be added to the ``Special Exposure Cohort'' 
(the ``Cohort''), various groups of workers whose claims for cancer 
under EEOICPA can be adjudicated without demonstrating that their 
cancer was ``at least as likely as not'' caused by radiation doses they 
incurred in the performance of duty. In brief, EEOICPA authorizes HHS 
to designate such classes of employees for addition to the Cohort when 
NIOSH lacks sufficient information to estimate with sufficient accuracy 
the radiation doses of the employees, if HHS also finds that the health 
of members of the class may have been endangered by the radiation dose 
the class potentially incurred. HHS must also obtain the advice of the 
Advisory Board on Radiation and Worker Health (the Board) in 
establishing such findings. On March 7, 2003, HHS proposed procedures 
for adding such classes to the Cohort in a notice of proposed 
rulemaking at 42 CFR Part 83.
    The HHS procedures authorize a variety of individuals and entities 
to submit petitions, as specified under Sec.  83.7. Petitioners are 
required to provide the information specified in Sec.  83.9 to qualify 
their petitions for a complete evaluation by HHS and the Board. HHS has 
developed two petition forms to assist the petitioners in providing 
this required information efficiently and completely, and an 
Authorization Form to permit a respondent to authorize another party to 
submit a petition on their behalf, as specified in Sec.  83.7. Petition 
Form A is a one-page form to be used by EEOICPA claimants for whom 
NIOSH will have attempted to conduct dose reconstructions and will have 
determined that available information is not sufficient to complete the 
dose reconstruction. The form addresses the informational requirements 
specified under Sec.  83.9(a) and (b). Petition Form B, accompanied by 
separate instructions, is intended for all other petitioners. The form 
addresses the informational requirements specified under Sec.  83.9(a) 
and (c). Forms A and B can be submitted electronically as well as in 
hard copy. Petitioners should be aware that HHS is not requiring 
petitioners to use the forms. Petitioners can choose to submit 
petitions as letters or in other formats, but petitions must meet the 
informational requirements referenced above. NIOSH expects, however, 
that all petitioners for whom Form A would be appropriate will actually 
use the form, since NIOSH will provide it to them upon determining that 
their dose reconstruction cannot be completed and encourage them to 
submit the petition. NIOSH expects the large majority of petitioners 
for whom Form B would be appropriate will also use the form, since it 
provides a simple, organized format for addressing the informational 
requirements of a petition.
    NIOSH will use the information obtained through the petition for 
the following purposes: (a) Identify the petitioner(s), obtain their 
contact information, and establish that the petitioner(s) is qualified 
and intends to petition HHS; (b) establish an initial definition of the 
class of employees being proposed to be considered for addition to the 
Cohort; (c) determine whether there is justification to require HHS to 
evaluate whether or not to designate the proposed class as an addition 
to the Cohort (such an evaluation involves potentially extensive data 
collection, analysis, and related deliberations by NIOSH, the Board, 
and HHS); and, (d) target an evaluation by HHS to examine relevant 
potential limitations of radiation monitoring and/or dosimetry-relevant 
records and to examine the potential for related radiation exposures 
that might have endangered the health of members of the class.
    Finally, under Sec.  83.18, petitioners may contest the proposed 
decision of the Secretary to add or deny adding classes of employees to 
the cohort by submitting evidence that the proposed decision relies on 
a record of either factual or procedural errors in the implementation 
of these procedures. NIOSH estimates that the time to prepare and 
submit such a challenge is 45 minutes. Because of the uniqueness of 
this submission, NIOSH is not providing a form.
    There are no costs to petitioners unless a petitioner chooses to 
purchase the services of a expert in dose reconstruction, an option 
provided for under 42 CFR 83.9(c)(2)(iii). The petitioner would assume 
the financial burden of purchasing such services at their option. In 
such cases, HHS estimates a report by such an expert may cost between 
$640 and $6,400, depending on the scope of the petition and access to 
relevant information. This is based on an estimate of costs of $80 per 
hour for contractual services by a health physicist, who NIOSH 
estimates would be employed within a range of eight to eighty hours to 
conduct and prepare a report on the required assessment.
    The total estimated annual burden hours are 238.

                                       Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      No. of      Average burden
 Form name & number (CFR reference)          Respondents              No. of       responses per  per respondent
                                                                    respondents     respondent       (in hours)
----------------------------------------------------------------------------------------------------------------
Form A 42 CFR 83.9.................  Petitioners using Form A...              30               1            3/60
Form B 42 CFR 83.9.................  Petitioners using Form B...              40               1               5
42 CFR 83.9........................  Petitioners not using Form                5               1               6
                                      B.
42 CFR 83.18.......................  Petitioners Appealing                     5               1           45/60
                                      proposed decisions.

[[Page 42093]]

 
Authorization Form 42 CFR 83.7.....  Person authorizing a party               20               1            3/60
                                      to submit a petition on
                                      his/her behalf.
----------------------------------------------------------------------------------------------------------------


    Dated: July 13, 2010.
Carol Walker,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 2010-17685 Filed 7-19-10; 8:45 am]
BILLING CODE 4163-18-P
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