80 FR 18238 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 64 (April 3, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 64 (April 3, 2015)
| Page Range | 18238-18239 | |
| FR Document | 2015-07670 |
[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)] [Notices] [Pages 18238-18239] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07670] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-15-0929] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) 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; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) 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; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected]. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written [[Page 18239]] comments should be received within 30 days of this notice. Proposed Project World Trade Center Health Program Petition for the Addition of a New WTC-Related Health Condition for Coverage under the World Trade Center (WTC) Health Program (OMB No. 0920-0929, expiration 04/30/ 2015)--Revision--Centers for Disease Control and Prevention (CDC), National Institutes for Occupational Safety and Health (NIOSH). Background and Brief Description Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act) to add Title XXXIII establishing the WTC Health Program within the Department of Health and Human Services (HHS). The WTC Health Program provides medical monitoring and treatment benefits to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery, and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania (responders), and to eligible persons who were present in the dust or dust cloud on September 11, 2001 or who worked, resided, or attended school, childcare, or adult daycare in the New York City disaster area (survivors). PHS Act Sec. 3312(a)(3) identifies a list of health conditions for which individuals who are enrolled in the WTC Health Program may be monitored or treated. PHS Act Sec. 3312(a)(6)(B) specifies that interested parties may petition the Administrator of the WTC Health Program to request that a new health condition be added to the List of WTC-Related Health Conditions in 42 CFR 88.1. To aid the petitioner, the WTC Health Program provides a petition form to be completed and then sent to the Administrator for review. However, the petitioner is not required to use the form, and may submit a petition in a different format, provided it contains all of the data elements requested on the form. Data elements include the interested party's name, contact information, signature, and a statement about the medical basis for the relationship/association between the 9/11 exposure and the proposed health condition, which the Administrator of the WTC Health Program will use to determine whether to propose a rule to add the condition, to not to add the condition, or to seek a recommendation from the Scientific/Technical Advisory Committee (STAC). The petition form is amended slightly to reflect a WTC Health Program policy change. The current form asks respondents to offer reference to ``a peer-reviewed, published, epidemiologic study.'' The revised form will ask respondents to reference ``peer-reviewed, published, epidemiologic and/or direct observational studies.'' The submission of a petition is purely voluntary, and is not required or otherwise compelled by NIOSH or the WTC Health Program. NIOSH expects to receive no more than 20 submissions annually. Petitioners include prospective and enrolled WTC responders, screening- eligible survivors, certified-eligible survivors, or members of groups who advocate on behalf of responders or survivors, such as physicians. It is estimated that an individual spends an average of 40 hours gathering information to substantiate a request to add a health condition and assembling the petition. The total estimated annualized burden hours are 800. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondent Form name Number of responses per per response respondents respondent (hours) ---------------------------------------------------------------------------------------------------------------- Responder/Survivor/Advocate Petition for the 20 1 40 (physician). addition of health conditions. ---------------------------------------------------------------------------------------------------------------- Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2015-07670 Filed 4-2-15; 8:45 am] BILLING CODE 4163-18-P
![18238 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices
of marketed and investigational human Within the subsequent 30 days, FDA voting or nonvoting consumer
drug products for use in the treatment will compile a list of consumer representatives will not participate in
of cancer. organizations that will participate in the the selection process.
G. Science Advisory Board to the selection process and will forward to Dated: March 30, 2015.
National Center for Toxicological each such organization a ballot listing at Leslie Kux,
Research: Reviews and advises the least two qualified nominees selected by
Associate Commissioner for Policy.
Agency on the establishment, the Agency based on the nominations
received, together with each nominee’s [FR Doc. 2015–07605 Filed 4–2–15; 8:45 am]
implementation and evaluation of the
research programs and regulatory current curriculum vitae or resume. BILLING CODE 4164–01–P
responsibilities as it relates to NCTR. Ballots are to be filled out and returned
The Board will also provide an extra- to FDA within 30 days. The nominee
receiving the highest number of votes DEPARTMENT OF HEALTH AND
Agency review in ensuring that the HUMAN SERVICES
research programs at NCTR are ordinarily will be selected to serve as
scientifically sound and pertinent. the member representing consumer
Centers for Disease Control and
H. Vaccines and Related Biological interests for that particular advisory
Prevention
Products Advisory Committee: Reviews committee or panel.
and evaluates data concerning the [30Day–15–0929]
IV. Nomination Procedures
safety, effectiveness, and appropriate Agency Forms Undergoing Paperwork
Any interested person or organization
use of vaccines and related biological may nominate one or more qualified Reduction Act Review
products which are intended for use in persons to represent consumer interests
the prevention, treatment, or diagnosis on the Agency’s advisory committees or The Centers for Disease Control and
of human diseases, as well as considers panels. Self-nominations are also Prevention (CDC) has submitted the
the quality and relevance of FDA’s accepted. Nominations should include a following information collection request
research program which provides cover letter and a current curriculum to the Office of Management and Budget
scientific support for the regulation of vitae or resume for each nominee, (OMB) for review and approval in
these products. including a current business and/or accordance with the Paperwork
home address, telephone number, and Reduction Act of 1995. The notice for
II. Criteria for Members
email address if available, and a list of the proposed information collection is
Persons nominated for membership as consumer or community-based published to obtain comments from the
consumer representatives on organizations for which the candidate public and affected agencies.
committees or panels should meet the can demonstrate active participation. Written comments and suggestions
following criteria: (1) Demonstrate ties FDA seeks to include the views of from the public and affected agencies
to consumer and community-based women and men, members of all racial concerning the proposed collection of
organizations, (2) be able to analyze and ethnic groups, and individuals with information are encouraged. Your
technical data, (3) understand research and without disabilities on its advisory comments should address any of the
design, (4) discuss benefits and risks, committees and therefore, encourages following: (a) Evaluate whether the
and (5) evaluate the safety and efficacy nominations of appropriately qualified proposed collection of information is
of products under review. The candidates from these groups. necessary for the proper performance of
consumer representative should be able Nominations should also specify the the functions of the agency, including
to represent the consumer perspective advisory committee(s) or panel(s) for whether the information will have
on issues and actions before the which the nominee is recommended. In practical utility; (b) Evaluate the
advisory committee; serve as a liaison addition, nominations should include accuracy of the agencies estimate of the
between the committee and interested confirmation that the nominee is aware burden of the proposed collection of
consumers, associations, coalitions, and of the nomination, unless self- information, including the validity of
consumer organizations; and facilitate nominated. FDA will ask potential the methodology and assumptions used;
dialogue with the advisory committees candidates to provide detailed (c) Enhance the quality, utility, and
on scientific issues that affect information concerning such matters as clarity of the information to be
consumers. financial holdings, employment, and collected; (d) Minimize the burden of
research grants and/or contracts to the collection of information on those
III. Selection Procedures
permit evaluation of possible sources of who are to respond, including through
Selection of members representing conflicts of interest. Members will be the use of appropriate automated,
consumer interests is conducted invited to serve for terms up to 4 years. electronic, mechanical, or other
through procedures that include the use FDA will review all nominations technological collection techniques or
of organizations representing the public received within the specified other forms of information technology,
interest and public advocacy groups. timeframes and prepare a ballot e.g., permitting electronic submission of
These organizations recommend containing the names of qualified responses; and (e) Assess information
nominees for the Agency’s selection. nominees. Names not selected will collection costs.
Representatives from the consumer remain on a list of eligible nominees To request additional information on
health branches of Federal, State, and and be reviewed periodically by FDA to the proposed project or to obtain a copy
local governments also may participate determine continued interest. Upon of the information collection plan and
asabaliauskas on DSK5VPTVN1PROD with NOTICES
in the selection process. Any consumer selecting qualified nominees for the instruments, call (404) 639–7570 or
organization interested in participating ballot, FDA will provide those send an email to omb@cdc.gov. Written
in the selection of an appropriate voting consumer organizations that are comments and/or suggestions regarding
or nonvoting member to represent participating in the selection process the items contained in this notice
consumer interests should send a letter with the opportunity to vote on the should be directed to the Attention:
stating that interest to FDA (see listed nominees. Only organizations CDC Desk Officer, Office of Management
ADDRESSES) within 30 days of vote in the selection process. Persons and Budget, Washington, DC 20503 or
publication of this document. who nominate themselves to serve as by fax to (202) 395–5806. Written
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![Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices 18239
comments should be received within 30 present in the dust or dust cloud on whether to propose a rule to add the
days of this notice. September 11, 2001 or who worked, condition, to not to add the condition,
resided, or attended school, childcare, or to seek a recommendation from the
Proposed Project
or adult daycare in the New York City Scientific/Technical Advisory
World Trade Center Health Program disaster area (survivors). Committee (STAC).
Petition for the Addition of a New WTC- PHS Act § 3312(a)(3) identifies a list The petition form is amended slightly
Related Health Condition for Coverage of health conditions for which to reflect a WTC Health Program policy
under the World Trade Center (WTC) individuals who are enrolled in the change. The current form asks
Health Program (OMB No. 0920–0929, WTC Health Program may be monitored respondents to offer reference to ‘‘a
expiration 04/30/2015)—Revision— peer-reviewed, published,
or treated. PHS Act § 3312(a)(6)(B)
Centers for Disease Control and epidemiologic study.’’ The revised form
specifies that interested parties may
Prevention (CDC), National Institutes for will ask respondents to reference ‘‘peer-
petition the Administrator of the WTC
Occupational Safety and Health reviewed, published, epidemiologic
Health Program to request that a new
(NIOSH). and/or direct observational studies.’’
health condition be added to the List of
Background and Brief Description WTC-Related Health Conditions in 42 The submission of a petition is purely
Title I of the James Zadroga 9/11 CFR 88.1. To aid the petitioner, the voluntary, and is not required or
Health and Compensation Act of 2010 WTC Health Program provides a otherwise compelled by NIOSH or the
(Pub. L. 111–347), amended the Public petition form to be completed and then WTC Health Program.
Health Service Act (PHS Act) to add sent to the Administrator for review. NIOSH expects to receive no more
Title XXXIII establishing the WTC However, the petitioner is not required than 20 submissions annually.
Health Program within the Department to use the form, and may submit a Petitioners include prospective and
of Health and Human Services (HHS). petition in a different format, provided enrolled WTC responders, screening-
The WTC Health Program provides it contains all of the data elements eligible survivors, certified-eligible
medical monitoring and treatment requested on the form. survivors, or members of groups who
benefits to eligible firefighters and Data elements include the interested advocate on behalf of responders or
related personnel, law enforcement party’s name, contact information, survivors, such as physicians. It is
officers, and rescue, recovery, and signature, and a statement about the estimated that an individual spends an
cleanup workers who responded to the medical basis for the relationship/ average of 40 hours gathering
September 11, 2001, terrorist attacks in association between the 9/11 exposure information to substantiate a request to
New York City, at the Pentagon, and in and the proposed health condition, add a health condition and assembling
Shanksville, Pennsylvania (responders), which the Administrator of the WTC the petition. The total estimated
and to eligible persons who were Health Program will use to determine annualized burden hours are 800.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (hours)
Responder/Survivor/Advocate (physician) ...... Petition for the addition of health conditions 20 1 40
Leroy A. Richardson, availability of a guidance for industry the SUPPLEMENTARY INFORMATION section
Chief, Information Collection Review Office, #211 entitled ‘‘Residual Solvents in for electronic access to the guidance
Office of Scientific Integrity, Office of the Animal Drug Products; Questions and document.
Associate Director for Science, Office of the Answers.’’ The questions and answers Submit electronic comments on the
Director, Centers for Disease Control and guidance addresses the United States guidance to http://www.regulations.gov.
Prevention. Pharmacopeia (USP) General Chapter Submit written comments to the
[FR Doc. 2015–07670 Filed 4–2–15; 8:45 am] <467> Residual Solvents that applies to Division of Dockets Management (HFA–
BILLING CODE 4163–18–P both human and veterinary drugs and to 305), Food and Drug Administration,
compendial and non-compendial drug 5630 Fishers Lane, Rm. 1061, Rockville,
products. This document answers MD 20852.
DEPARTMENT OF HEALTH AND questions regarding the Center for
HUMAN SERVICES FOR FURTHER INFORMATION CONTACT:
Veterinary Medicine’s (CVM) Heather Longstaff, Center for Veterinary
Food and Drug Administration implementation of USP <467> Residual Medicine (HFV–145), Food and Drug
Solvents. Administration, 7500 Standish Pl.,
[Docket No. FDA–2010–D–0566] DATES: Submit either electronic or Rockville, MD 20855, 240–402–0651,
written comments on Agency guidances email: heather.longstaff@fda.hhs.gov.
Residual Solvents in Animal Drug at any time. SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Products; Questions and Answers;
ADDRESSES: Submit written requests for
Guidance for Industry; Availability I. Background
single copies of the guidance to the
AGENCY: Food and Drug Administration, Communications Staff (HFV–12), Center In the Federal Register of December 3,
HHS. for Veterinary Medicine, Food and Drug 2010 (75 FR 75482), FDA published the
ACTION: Notice. Administration, 7519 Standish Pl., notice of availability for a draft guidance
Rockville, MD 20855. Send one self- entitled ‘‘Residual Solvents in Animal
SUMMARY: The Food and Drug addressed adhesive label to assist that Drug Products; Questions and Answers’’
Administration (FDA) is announcing the office in processing your request. See giving interested persons until February
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Document Created: 2015-12-18 15:29:18
Document Modified: 2015-12-18 15:29:18
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 80 FR 18238 |
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