Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, 72361-72362 [2012-29403]

Download as PDF Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Notices determines that the deficiencies are substantial or new substantial information is provided in the resubmission. The Agency will permit comparability protocols as described in 21 CFR 514.8(b)(2)(v) to be submitted as protocols without substantial data in a JINAD file. The Agency will continue to review and act on 90 percent of JINAD submissions consisting of protocols without substantial data within 100 days after the submission date. The Agency will develop guidance for a two-phased Chemistry, Manufacturing, and Controls technical section submission and review process under the JINAD file by the end of FY 2014. The Agency will develop and implement a question based review process for bioequivalence submissions by the end of FY 2016. At its discretion, the Agency may extend the timeline for completion if necessary, depending on available resources. To improve the timeliness and predictability of foreign preapproval inspections (PAIs), sponsors may voluntarily submit, at the beginning of the calendar year, a list of foreign manufacturing facilities that are included in abbreviated animal drug applications, supplemental animal drug applications, or investigational animal drug submissions and may be subject to foreign PAIs for the following fiscal year. If such a list is voluntarily submitted, the sponsor should submit a notification 30 days prior to submitting an abbreviated animal drug application, an abbreviated supplemental animal drug application, or generic investigational animal drug submission that informs the Agency that the application includes a foreign manufacturing facility. Should any changes to the annual list occur after its submission to the Agency, the sponsor may provide the updated information to the Agency. mstockstill on DSK4VPTVN1PROD with B. AGDUFA II Enhancements for a Modified Inflation Adjuster and Workload Adjuster Similar to AGDUFA I, we agreed to a fixed inflation adjuster over the 5-year period that results in the statutory revenues specified in sections 741(b) and 741(g)(3) of FD&C Act (21 U.S.C. 379j–21(b) and 379–21(g)(3)). AGDUFA II also modifies the base years for calculating the workload adjuster, as specified in the AGDUFA II performance goals letter, to ensure that it adequately captures changes in FDA’s workload during AGDUFA II. VerDate Mar<15>2010 17:19 Dec 04, 2012 Jkt 229001 72361 C. Impact of AGDUFA II Enhancements on User Fee Revenue DEPARTMENT OF HEALTH AND HUMAN SERVICES The following table summarizes FY 2014 baseline and added funding to support AGDUFA II program, as well as the AGDUFA II total 5-year revenue: National Institutes of Health Financial baseline Dollars FY 2014 Base Revenue 1 ......... One-Time Information Technology (IT) Funding ............... 6,478,000 Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery As part of a Federal Government-wide effort to streamline the process to seek feedback from the Total Statutory Revenue public on service delivery, the National for FY 2014 .................... 7,328,000 Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Total Financial Funding Health (NIH), has submitted a Generic Total 5-Year Revenue .............. 38,100,000 Information Collection Request (Generic ICR): ‘‘Generic Clearance for the 1 For each year in FY 2015 to FY 2018, the annual statutory revenue amounts established Collection of Qualitative Feedback on in section 741(b) of the FD&C Act may be fur- Agency Service Delivery’’ to OMB for ther adjusted by the workload adjuster for FY approval under the Paperwork 2015 to FY 2018 user fee revenues. Reduction Act (PRA) (44 U.S.C. 3501 et seq.). The total 5-year revenue for AGDUFA DATES: Comments must be submitted I was $27,100,000. The total 5-year within 30-days after publication of this revenue for AGDUFA II will be notice in the Federal Register. $38,100,000, which also includes oneADDRESSES: Written comments and/or time IT funding in the amount of suggestions regarding the item(s) $850,000 for FY 2014. contained in this notice, especially Additionally, the fee revenue regarding the estimated public burden distribution has been modified from 30 and associated response time, should be percent in application fees, 35 percent directed to the: Office of Management in product fees, and 35 percent in and Budget, Office of Regulatory Affairs, sponsor fees under AGDUFA I to 25 OIRA_submission@omb.eop.gov or by percent in application fees, 37.5 percent fax to 202–395–6974, Attention: Desk in product fees, and 37.5 percent in Officer for NIH. sponsor fees under AGDUFA II. The FOR FURTHER INFORMATION CONTACT: To purpose of changing the fee distribution request more information on the is to increase the revenue stream proposed project or to obtain a copy of stability and reduce application fee the data collection plans and costs. instruments, contact Brandie K. Taylor, III. What information should you know MA, Strategic Planning and Evaluation about the meeting? Branch, Office of Strategic Planning and Initiative Development, NIAID, NIH, We will convene a public meeting to 6610 Rockledge Drive, Room 2502, hear the public’s views on the proposed MSC, 6620, Bethesda, MD 20892, by recommendations for reauthorization of phone at (301) 451–3068 or Email your AGDUFA I. The public meeting will be request, including your address to: held on December 18, 2012, at FDA’s taylorbr@niaid.nih.gov. Metro Park North Campus (see SUPPLEMENTARY INFORMATION: Location). The meeting will include a Title: Generic Clearance for the presentation by FDA, and we will also Collection of Qualitative Feedback on provide an opportunity for other Agency Service Delivery (NIAID) . organizations and individuals to make Abstract: The information collection presentations at the meeting or to submit written comments to the docket. activity will garner qualitative customer and stakeholder feedback in an efficient, So that FDA can consider comments timely manner, in accordance with the and revise the recommendations as necessary, we request that comments be Administration’s commitment to improving service delivery. By submitted to the docket by January 4, qualitative feedback we mean 2013. information that provides useful Dated: December 3, 2012. insights on perceptions and opinions, Leslie Kux, but are not statistical surveys that yield Assistant Commissioner for Policy. quantitative results that can be [FR Doc. 2012–29499 Filed 11–26–12; 4:15 pm] generalized to the population of study. BILLING CODE 4160–01–P This feedback will provide insights into PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 SUMMARY: 850,000 E:\FR\FM\05DEN1.SGM 05DEN1 mstockstill on DSK4VPTVN1PROD with 72362 Federal Register / Vol. 77, No. 234 / Wednesday, December 5, 2012 / Notices customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: the target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential nonresponse bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results. The Agency received no comments in response to the 60-day notice published in the Federal Register of December 22, 2010 (75 FR 80542). Below we provide the NIAID’s projected average estimates for the next three years: Current Actions: New collection of information. Type of Review: New Collection. Affected Public: Individuals and Households, Businesses and Organizations, State, Local or Tribal Government. Average Expected Annual Number of activities: 25. Respondents: 28,000. Annual responses: 28,000. Frequency of Response: Once per request. Average minutes per response: Ranges from 15 minutes to 120 minutes. Burden hours: 16,100 hours. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information VerDate Mar<15>2010 17:19 Dec 04, 2012 Jkt 229001 unless it displays a currently valid Office of Management and Budget control number. Dated: November 27, 2012. Shamay D. Knox, NIAID Project Clearance Liaison. [FR Doc. 2012–29403 Filed 12–4–12; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: AIDS and AIDS Related Research. Date: December 12, 2012. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Mary Clare Walker, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5208, MSC 7852, Bethesda, MD 20892, (301) 435– 1165, walkermc@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel Member Conflict: AIDS Clinical Studies and Epidemiology Study Section. Date: December 13, 2012. Time: 11:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Mark P Rubert, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301–435– 1775, rubertm@csr.nih.gov. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Biobehavioral Mechanisms of Emotion, Stress and Health. Date: January 4, 2013. Time: 12:00 p.m. to 1:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Melissa Gerald, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3172, MSC 7848, Bethesda, MD 20892, (301) 408– 9107, geraldmel@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: November 28, 2012. David Clary, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2012–29304 Filed 12–4–12; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Review of Career Development Award. Date: December 18, 2012. Time: 9:00 a.m. to 10:00 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). E:\FR\FM\05DEN1.SGM 05DEN1

Agencies

[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Notices]
[Pages 72361-72362]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29403]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Generic Clearance for the Collection of Qualitative 
Feedback on Agency Service Delivery

SUMMARY: As part of a Federal Government-wide effort to streamline the 
process to seek feedback from the public on service delivery, the 
National Institute of Allergy and Infectious Diseases (NIAID), National 
Institutes of Health (NIH), has submitted a Generic Information 
Collection Request (Generic ICR): ``Generic Clearance for the 
Collection of Qualitative Feedback on Agency Service Delivery'' to OMB 
for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et 
seq.).

DATES: Comments must be submitted within 30-days after publication of 
this notice in the Federal Register.

ADDRESSES: 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: Office 
of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk 
Officer for NIH.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact Brandie K. Taylor, MA, Strategic Planning and 
Evaluation Branch, Office of Strategic Planning and Initiative 
Development, NIAID, NIH, 6610 Rockledge Drive, Room 2502, MSC, 6620, 
Bethesda, MD 20892, by phone at (301) 451-3068 or Email your request, 
including your address to: taylorbr@niaid.nih.gov.

SUPPLEMENTARY INFORMATION:
    Title: Generic Clearance for the Collection of Qualitative Feedback 
on Agency Service Delivery (NIAID) .
    Abstract: The information collection activity will garner 
qualitative customer and stakeholder feedback in an efficient, timely 
manner, in accordance with the Administration's commitment to improving 
service delivery. By qualitative feedback we mean information that 
provides useful insights on perceptions and opinions, but are not 
statistical surveys that yield quantitative results that can be 
generalized to the population of study. This feedback will provide 
insights into

[[Page 72362]]

customer or stakeholder perceptions, experiences and expectations, 
provide an early warning of issues with service, or focus attention on 
areas where communication, training or changes in operations might 
improve delivery of products or services. These collections will allow 
for ongoing, collaborative and actionable communications between the 
Agency and its customers and stakeholders. It will also allow feedback 
to contribute directly to the improvement of program management.
    Feedback collected under this generic clearance will provide useful 
information, but it will not yield data that can be generalized to the 
overall population. This type of generic clearance for qualitative 
information will not be used for quantitative information collections 
that are designed to yield reliably actionable results, such as 
monitoring trends over time or documenting program performance. Such 
data uses require more rigorous designs that address: the target 
population to which generalizations will be made, the sampling frame, 
the sample design (including stratification and clustering), the 
precision requirements or power calculations that justify the proposed 
sample size, the expected response rate, methods for assessing 
potential non-response bias, the protocols for data collection, and any 
testing procedures that were or will be undertaken prior fielding the 
study. Depending on the degree of influence the results are likely to 
have, such collections may still be eligible for submission for other 
generic mechanisms that are designed to yield quantitative results.
    The Agency received no comments in response to the 60-day notice 
published in the Federal Register of December 22, 2010 (75 FR 80542).
    Below we provide the NIAID's projected average estimates for the 
next three years:
    Current Actions: New collection of information.
    Type of Review: New Collection.
    Affected Public: Individuals and Households, Businesses and 
Organizations, State, Local or Tribal Government.
    Average Expected Annual Number of activities: 25.
    Respondents: 28,000.
    Annual responses: 28,000.
    Frequency of Response: Once per request.
    Average minutes per response: Ranges from 15 minutes to 120 
minutes.
    Burden hours: 16,100 hours.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid Office of Management and Budget control number.

    Dated: November 27, 2012.
Shamay D. Knox,
NIAID Project Clearance Liaison.
[FR Doc. 2012-29403 Filed 12-4-12; 8:45 am]
BILLING CODE 4140-01-P
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