Agency Information Collection Activities: Proposed Collection: Public Comment Request, 62636-62637 [2014-24870]

Download as PDF 62636 Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices tkelley on DSK3SPTVN1PROD with NOTICES guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 19, 2014. ADDRESSES: Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Heather Longstaff, Center for Veterinary Medicine (HFV–145), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–0651, email: heather.longstaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry (GFI #227) entitled ‘‘Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections.’’ It is intended to provide recommendations to industry regarding CMC data submitted to CVM to support approval of a new animal drug or abbreviated new animal drug. As specified in the Animal Drug User Fee Amendments of 2013 (ADUFA III) and Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II) respective goals letters, the Agency agreed to develop guidance for a twophased CMC technical section submission and review process by the end of fiscal year 2014. The two-phased process allows for two separate CMC submissions, each with its own review clock, and each including complete appropriate CMC information that is available for review at the time of submission. The draft guidance specifies the technical details of how the process works, the review clocks, the information that is appropriate for each technical section submission, and the possible review outcomes. The guidance also includes CVM’s recommendations for meetings between the Division of Manufacturing Technologies and the sponsor during this process to ensure concurrence with the approach used for the CMC technical section. VerDate Sep<11>2014 16:28 Oct 17, 2014 Jkt 235001 II. Significance of Guidance This level 1 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 requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in this guidance have been approved under 0910–0032 and 0910–0669. IV. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. V. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: October 15, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–24796 Filed 10–17–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Health Resources and Services Administration, HHS. AGENCY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 ACTION: Notice. In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this Information Collection Request must be received no later than December 19, 2014. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 10–29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: The Secretary’s Discretionary Advisory Committee on Heritable Disorders in Newborns and Children’s Public Health System Assessment Surveys OMB No. 0915-xxxx–New Abstract: The purpose of the public health system assessment surveys is to inform the Secretary’s Discretionary Advisory Committee on Heritable Disorders in Newborns and Children (Committee) on the ability to add newborn screening for particular conditions within a state, including the feasibility, readiness, and overall capacity to screen for a new condition. The Committee was established under the Public Health Service Act, 42 U.S.C. 217a: Advisory Councils or Committees. This Committee fulfills the functions previously undertaken by the former Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children, established under Section 1111 of the Public Health Service Act (PHS), 42 U.S.C. 300b–10, as amended in the Newborn Screening Saves Lives Act of 2008. The Committee is governed by the provisions of the Federal Advisory Committee Act (FACA), as SUMMARY: E:\FR\FM\20OCN1.SGM 20OCN1 62637 Federal Register / Vol. 79, No. 202 / Monday, October 20, 2014 / Notices amended (5 U.S.C. App.), which sets forth standards for the formation and use of advisory committees. The purpose of the Committee is to provide the Secretary with recommendations, advice, and technical information regarding the most appropriate application of technologies, policies, guidelines, and standards for: (a) Effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders; and (b) enhancing the ability of state and local health agencies to provide for newborn and child screening, counseling, and health care services for newborns and children having, or at risk for, heritable disorders. Specifically, the Committee makes systematic evidence-based recommendations on newborn screening for conditions that have the potential to change the health outcomes for newborns. The Committee tasks an external workgroup to conduct systematic evidence based reviews. The reviews are of rare, genetic conditions and their corresponding newborn screening test(s), confirmatory test(s), and treatment(s). Reviews also include an analysis of the benefits and harms of newborn screening for a selected condition at a population level and an assessment of state public health newborn screening programs’ ability to implement the screening of a new condition. Need and Proposed Use of the Information: HRSA proposes that the data collection surveys be administered by the Committee’s external Condition Review Workgroup to all state newborn screening programs in the United States. The surveys were developed to capture the following: (1) The readiness of state public health newborn screening programs to expand newborn screening to include the target condition; (2) specific requirements of screening for the condition would hinder or facilitate its implementation in each state; and (3) estimated timeframes needed for each state to complete major milestones toward full newborn screening of the condition. The data gathered will inform the Committee on the following: (1) Feasibility of implementing populationbased screening for the target condition; (2) readiness of state newborn screening programs to adopt screening for the condition; (3) identify gaps in feasibility Number of respondents Form name Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours INITIAL Survey ..................................................................... FOLLOW-UP Survey ........................................................... 1 30 1 1 59 30 10.0 2.0 590 60 Total .............................................................................. 59 ........................ 89 ........................ 650 1 Up to 30 states and/or territories will be asked to complete a follow-up survey. HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. tkelley on DSK3SPTVN1PROD with NOTICES 59 or readiness to screen for the condition; and (4) identify areas of technical assistance and resources needed to facilitate screening for conditions with low feasibility or readiness. Likely Respondents: The respondents to the survey will be state newborn screening programs. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. Total Estimated Annualized burden hours: Dated: October 10, 2014. Jackie Painter, Acting Director, Division of Policy and Information Coordination. [FR Doc. 2014–24870 Filed 10–17–14; 8:45 am] BILLING CODE 4165–15–P VerDate Sep<11>2014 16:28 Oct 17, 2014 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review SUMMARY: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received no later than November 19, 2014. Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to OIRA_ submission@omb.eop.gov or by fax to 202–395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the ADDRESSES: E:\FR\FM\20OCN1.SGM 20OCN1

Agencies

[Federal Register Volume 79, Number 202 (Monday, October 20, 2014)]
[Notices]
[Pages 62636-62637]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24870]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995), the Health Resources and Services 
Administration (HRSA) announces plans to submit an Information 
Collection Request (ICR), described below, to the Office of Management 
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks 
comments from the public regarding the burden estimate, below, or any 
other aspect of the ICR.

DATES: Comments on this Information Collection Request must be received 
no later than December 19, 2014.

ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA 
Information Collection Clearance Officer, Room 10-29, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
draft instruments, email paperwork@hrsa.gov or call the HRSA 
Information Collection Clearance Officer at (301) 443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    Information Collection Request Title: The Secretary's Discretionary 
Advisory Committee on Heritable Disorders in Newborns and Children's 
Public Health System Assessment Surveys OMB No. 0915-xxxx-New
    Abstract: The purpose of the public health system assessment 
surveys is to inform the Secretary's Discretionary Advisory Committee 
on Heritable Disorders in Newborns and Children (Committee) on the 
ability to add newborn screening for particular conditions within a 
state, including the feasibility, readiness, and overall capacity to 
screen for a new condition.
    The Committee was established under the Public Health Service Act, 
42 U.S.C. 217a: Advisory Councils or Committees. This Committee 
fulfills the functions previously undertaken by the former Secretary's 
Advisory Committee on Heritable Disorders in Newborns and Children, 
established under Section 1111 of the Public Health Service Act (PHS), 
42 U.S.C. 300b-10, as amended in the Newborn Screening Saves Lives Act 
of 2008. The Committee is governed by the provisions of the Federal 
Advisory Committee Act (FACA), as

[[Page 62637]]

amended (5 U.S.C. App.), which sets forth standards for the formation 
and use of advisory committees. The purpose of the Committee is to 
provide the Secretary with recommendations, advice, and technical 
information regarding the most appropriate application of technologies, 
policies, guidelines, and standards for: (a) Effectively reducing 
morbidity and mortality in newborns and children having, or at risk 
for, heritable disorders; and (b) enhancing the ability of state and 
local health agencies to provide for newborn and child screening, 
counseling, and health care services for newborns and children having, 
or at risk for, heritable disorders. Specifically, the Committee makes 
systematic evidence-based recommendations on newborn screening for 
conditions that have the potential to change the health outcomes for 
newborns.
    The Committee tasks an external workgroup to conduct systematic 
evidence based reviews. The reviews are of rare, genetic conditions and 
their corresponding newborn screening test(s), confirmatory test(s), 
and treatment(s). Reviews also include an analysis of the benefits and 
harms of newborn screening for a selected condition at a population 
level and an assessment of state public health newborn screening 
programs' ability to implement the screening of a new condition.
    Need and Proposed Use of the Information: HRSA proposes that the 
data collection surveys be administered by the Committee's external 
Condition Review Workgroup to all state newborn screening programs in 
the United States. The surveys were developed to capture the following: 
(1) The readiness of state public health newborn screening programs to 
expand newborn screening to include the target condition; (2) specific 
requirements of screening for the condition would hinder or facilitate 
its implementation in each state; and (3) estimated timeframes needed 
for each state to complete major milestones toward full newborn 
screening of the condition.
    The data gathered will inform the Committee on the following: (1) 
Feasibility of implementing population-based screening for the target 
condition; (2) readiness of state newborn screening programs to adopt 
screening for the condition; (3) identify gaps in feasibility or 
readiness to screen for the condition; and (4) identify areas of 
technical assistance and resources needed to facilitate screening for 
conditions with low feasibility or readiness.
    Likely Respondents: The respondents to the survey will be state 
newborn screening programs.
    Burden Statement: Burden in this context means the time expended by 
persons to generate, maintain, retain, disclose or provide the 
information requested. This includes the time needed to review 
instructions; to develop, acquire, install and utilize technology and 
systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information; to search data sources; to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information. The total annual burden hours estimated for 
this Information Collection Request are summarized in the table below.
    Total Estimated Annualized burden hours:

 
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
INITIAL Survey..................              59               1              59            10.0             590
FOLLOW-UP Survey................          \1\ 30               1              30             2.0              60
                                 -------------------------------------------------------------------------------
    Total.......................              59  ..............              89  ..............             650
----------------------------------------------------------------------------------------------------------------
\1\ Up to 30 states and/or territories will be asked to complete a follow-up survey.

    HRSA specifically requests comments on (1) the necessity and 
utility of the proposed information collection for the proper 
performance of the agency's functions, (2) the accuracy of the 
estimated burden, (3) ways to enhance the quality, utility, and clarity 
of the information to be collected, and (4) the use of automated 
collection techniques or other forms of information technology to 
minimize the information collection burden.

    Dated: October 10, 2014.
Jackie Painter,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2014-24870 Filed 10-17-14; 8:45 am]
BILLING CODE 4165-15-P