Proposed Data Collections Submitted for Public Comment and Recommendations, 55496-55497 [2014-22010]

Download as PDF 55496 Federal Register / Vol. 79, No. 179 / Tuesday, September 16, 2014 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden hours Type of respondent Form name Sentinel Family Cohort ..................... Sentinel Family Cohort ..................... Cohort Intake .................................... Cohort Weekly Illness Reporting ..... 360 360 1 12 10/60 3/60 60 216 Total ........................................... ........................................................... ........................ ........................ ........................ 1,109 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. 2014–22009 Filed 9–15–14; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–14–0740] tkelley on DSK3SPTVN1PROD with NOTICES Proposed Data Collections Submitted for Public Comment and Recommendations The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. To request more information on the below proposed project or to obtain a copy of the information collection plan and instruments, call 404–639–7570 and send comments to Leroy A. Richardson, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an email to omb@ cdc.gov. Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. 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; (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 VerDate Sep<11>2014 18:22 Sep 15, 2014 Jkt 232001 technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. 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. Written comments should be received within 60 days of this notice. Proposed Project Medical Monitoring Project (MMP)— (OMB No. 0920–0740, Expiration: 5/31/ 2015)—Revision—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Centers for Disease Control and Prevention (CDC), Division of HIV/AIDS Prevention (DHAP) requests a revision of the currently approved Information Collection Request: ‘‘Medical Monitoring Project’’ expiring May 31, 2015. This data collection addresses the need for national estimates of access to and utilization of HIV-related medical care and services, the quality of HIVrelated ambulatory care, and HIVrelated behaviors and clinical outcomes. For the proposed project, the same data collection methods will be used as for the currently approved project. Data would be collected from a probability sample of HIV-diagnosed adults in the U.S. who consent to an interview and abstraction of their medical records. As for the currently approved project, deidentified information would also be extracted from HIV case surveillance records for a dataset, referred to as the PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 minimum dataset, which is used to assess non-response bias, for quality control, to improve the ability of MMP to monitor ongoing care and treatment of HIV-infected persons, and to make inferences from the MMP sample to HIV-diagnosed persons nationally. No other Federal agency collects such nationally representative populationbased information from HIV-diagnosed adults. The data are expected to have significant implications for policy, program development, and resource allocation at the state/local and national levels. The changes proposed in this request update the data collection system to meet prevailing information needs and enhance the value of MMP data, while remaining within the scope of the currently approved project purpose. The result is a 16% reduction in burden, or a reduction of 1,397 total burden hours annually. A change in sampling methods accounts for the net reduction in burden. Specifically, sampling from the existing HIV case surveillance database, the National HIV Surveillance System (NHSS, OMB Control No. 0920–0573, Exp. 2/29/2016) would replace the current health care-facility-based sampling. This change in sampling methods would broaden participation in MMP to all HIV-infected persons who have been diagnosed and reported to the NHSS, a population that is more representative of persons living with HIV than are persons receiving HIV medical care. Sampling from NHSS will allow MMP to address key information gaps related to increasing access to care, one of three strategic areas of national focus of the National HIV/AIDS Strategy. The change in project sampling methods reduces the amount of time health care facility staff will spend on project activities, substantially reducing burden hours and offsetting increases in burden from other changes, listed below. Restoration of the original sample of 26 geographic primary sampling units is proposed in this request, for more complete coverage of the population of E:\FR\FM\16SEN1.SGM 16SEN1 55497 Federal Register / Vol. 79, No. 179 / Tuesday, September 16, 2014 / Notices interest. Three project areas that initially participated in MMP—and were subsequently dropped in 2009 because funding was restricted—will be reinstated as primary sampling units if funding allows. Increasing the sample size in three areas that were previously allocated comparatively small samples (Georgia, Illinois, and Pennsylvania) is expected to improve the ability to produce representative local estimates in these areas. Health care facility staff may be asked to look up contact information for sampled persons with incomplete or incorrect contact information in NHSS; this was not necessary in prior MMP cycles because the patient samples were drawn from facility records. Finally, changes were made that did not affect the burden, listed below: • The interview instrument was revised to enable the collection of critical information from HIV-infected persons not receiving medical care and to improve question coherence, boost the efficiency of the data collection, and increase the relevance and value of the in the interview and facilitate communication between respondent and interviewer, for example, by allowing interviewers to respond appropriately to a respondent’s visual cues. Videoconferencing will also allow the interviewer to ensure that the respondent is using the correct response cards for interview questions. No audio/ audiovisual recordings will be made of the interviews, including interviews administered by videoconferencing. This proposed data collection would supplement the National HIV Surveillance System (NHSS, OMB Control No. 0920–0573, Exp. 2/29/2016) in 26 selected state and local health departments, which collect information on persons diagnosed with, living with, and dying from HIV infection and AIDS. The participation of respondents is voluntary. There is no cost to the respondents other than their time. Through their participation, respondents will help to improve programs to prevent HIV infection as well as services for those who already have HIV. information. These changes were based on an evaluation of the currently approved MMP interview instrument involving stakeholders, as well as a pilot which evaluated new questions (Formative Research and Tool Development, OMB Control No. 0920– 0840, expiration 2/29/2016). These revisions did not change the average time required to complete the interview. • Six data elements were removed from the medical record abstraction form and two data elements were added. Because the medical records are abstracted by MMP staff, these changes do not affect the burden of the project on the public. • Sampled persons may be interviewed wherever they currently reside, conditional on local law and policy, and in a manner specified by a written, project-specific agreement with the HIV surveillance unit at the person’s local health department. • Videoconferencing was added as an optional mode of interview administration. Administering the interview via videoconferencing will provide more flexibility for participating ESTIMATED ANNUALIZED BURDEN HOURS Number of responses per respondent Average hours per response (in hours) 8,720 2,180 1 1 45/60 2/60 6,540 73 ............................................... 1,090 1 5/60 91 ............................................... 8,720 1 3/60 436 ............................................... ........................ ........................ ........................ 7,140 Number of respondents Type of respondent Form name Sampled, Eligible HIV-Infected Persons ...... Facility office staff looking up contact information. Facility office staff approaching sampled persons for enrollment. Facility office staff pulling medical records ... Interview Questionnaire ........ ............................................... Total ....................................................... 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. 2014–22010 Filed 9–15–14; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration FOR FURTHER INFORMATION CONTACT: tkelley on DSK3SPTVN1PROD with NOTICES [Docket No. FDA–2014–D–1288] Draft Guidance for Industry: Electronic Submission of Lot Distribution Reports; Availability; Correction AGENCY: Food and Drug Administration, HHS. ACTION: 18:22 Sep 15, 2014 Lori J. Churchyard, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. In the Federal Register of Friday, August 29, SUPPLEMENTARY INFORMATION: Notice; correction. VerDate Sep<11>2014 The Food and Drug Administration is correcting a notice entitled ‘‘Draft Guidance for Industry: Electronic Submission of Lot Distribution Reports; Availability’’ that appeared in the Federal Register of August 29, 2014 (79 FR 51576). The document announced the availability of a draft guidance entitled ‘‘Guidance for Industry: Electronic Submission of Lot Distribution Reports’’ dated August 2014. The document was published with the incorrect docket number. This document corrects that error. SUMMARY: Jkt 232001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 Total burden hours 2014, in FR Doc. 2014–20635, on page 51576, the following correction is made: 1. On page 51576, in the first column, in the Docket No. heading, ‘‘[FDA– 2014–S–0009]’’ is corrected to read ‘‘[FDA–2014–D–1288]’’. Dated: September 10, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–22015 Filed 9–15–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review Amended; Notice of Meeting Notice is hereby given of a change in the meeting of the Neurotransporters, Receptors, and Calcium Signaling Study E:\FR\FM\16SEN1.SGM 16SEN1

Agencies

[Federal Register Volume 79, Number 179 (Tuesday, September 16, 2014)]
[Notices]
[Pages 55496-55497]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22010]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-14-0740]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    The Centers for Disease Control and Prevention (CDC), as part of 
its continuing effort to reduce public burden, invites the general 
public and other Federal agencies to take this opportunity to comment 
on proposed and/or continuing information collections, as required by 
the Paperwork Reduction Act of 1995. To request more information on the 
below proposed project or to obtain a copy of the information 
collection plan and instruments, call 404-639-7570 and send comments to 
Leroy A. Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or 
send an email to omb@cdc.gov.
    Comments submitted in response to this notice will be summarized 
and/or included in the request for Office of Management and Budget 
(OMB) approval. 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; (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; and (e) 
estimates of capital or start-up costs and costs of operation, 
maintenance, and purchase of services to provide information. Burden 
means the total time, effort, or financial resources expended by 
persons to generate, maintain, retain, disclose or provide information 
to or for a Federal agency. 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. Written comments should be received within 60 
days of this notice.

Proposed Project

    Medical Monitoring Project (MMP)--(OMB No. 0920-0740, Expiration: 
5/31/2015)--Revision--National Center for HIV/AIDS, Viral Hepatitis, 
STD, and TB Prevention (NCHHSTP), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC), Division of 
HIV/AIDS Prevention (DHAP) requests a revision of the currently 
approved Information Collection Request: ``Medical Monitoring Project'' 
expiring May 31, 2015. This data collection addresses the need for 
national estimates of access to and utilization of HIV-related medical 
care and services, the quality of HIV-related ambulatory care, and HIV-
related behaviors and clinical outcomes.
    For the proposed project, the same data collection methods will be 
used as for the currently approved project. Data would be collected 
from a probability sample of HIV-diagnosed adults in the U.S. who 
consent to an interview and abstraction of their medical records. As 
for the currently approved project, de-identified information would 
also be extracted from HIV case surveillance records for a dataset, 
referred to as the minimum dataset, which is used to assess non-
response bias, for quality control, to improve the ability of MMP to 
monitor ongoing care and treatment of HIV-infected persons, and to make 
inferences from the MMP sample to HIV-diagnosed persons nationally. No 
other Federal agency collects such nationally representative 
population-based information from HIV-diagnosed adults. The data are 
expected to have significant implications for policy, program 
development, and resource allocation at the state/local and national 
levels.
    The changes proposed in this request update the data collection 
system to meet prevailing information needs and enhance the value of 
MMP data, while remaining within the scope of the currently approved 
project purpose. The result is a 16% reduction in burden, or a 
reduction of 1,397 total burden hours annually.
    A change in sampling methods accounts for the net reduction in 
burden. Specifically, sampling from the existing HIV case surveillance 
database, the National HIV Surveillance System (NHSS, OMB Control No. 
0920-0573, Exp. 2/29/2016) would replace the current health care-
facility-based sampling. This change in sampling methods would broaden 
participation in MMP to all HIV-infected persons who have been 
diagnosed and reported to the NHSS, a population that is more 
representative of persons living with HIV than are persons receiving 
HIV medical care. Sampling from NHSS will allow MMP to address key 
information gaps related to increasing access to care, one of three 
strategic areas of national focus of the National HIV/AIDS Strategy.
    The change in project sampling methods reduces the amount of time 
health care facility staff will spend on project activities, 
substantially reducing burden hours and offsetting increases in burden 
from other changes, listed below.
    Restoration of the original sample of 26 geographic primary 
sampling units is proposed in this request, for more complete coverage 
of the population of

[[Page 55497]]

interest. Three project areas that initially participated in MMP--and 
were subsequently dropped in 2009 because funding was restricted--will 
be reinstated as primary sampling units if funding allows.
    Increasing the sample size in three areas that were previously 
allocated comparatively small samples (Georgia, Illinois, and 
Pennsylvania) is expected to improve the ability to produce 
representative local estimates in these areas.
    Health care facility staff may be asked to look up contact 
information for sampled persons with incomplete or incorrect contact 
information in NHSS; this was not necessary in prior MMP cycles because 
the patient samples were drawn from facility records.
    Finally, changes were made that did not affect the burden, listed 
below:
     The interview instrument was revised to enable the 
collection of critical information from HIV-infected persons not 
receiving medical care and to improve question coherence, boost the 
efficiency of the data collection, and increase the relevance and value 
of the information. These changes were based on an evaluation of the 
currently approved MMP interview instrument involving stakeholders, as 
well as a pilot which evaluated new questions (Formative Research and 
Tool Development, OMB Control No. 0920-0840, expiration 2/29/2016). 
These revisions did not change the average time required to complete 
the interview.
     Six data elements were removed from the medical record 
abstraction form and two data elements were added. Because the medical 
records are abstracted by MMP staff, these changes do not affect the 
burden of the project on the public.
     Sampled persons may be interviewed wherever they currently 
reside, conditional on local law and policy, and in a manner specified 
by a written, project-specific agreement with the HIV surveillance unit 
at the person's local health department.
     Videoconferencing was added as an optional mode of 
interview administration. Administering the interview via 
videoconferencing will provide more flexibility for participating in 
the interview and facilitate communication between respondent and 
interviewer, for example, by allowing interviewers to respond 
appropriately to a respondent's visual cues. Videoconferencing will 
also allow the interviewer to ensure that the respondent is using the 
correct response cards for interview questions. No audio/audiovisual 
recordings will be made of the interviews, including interviews 
administered by videoconferencing.
    This proposed data collection would supplement the National HIV 
Surveillance System (NHSS, OMB Control No. 0920-0573, Exp. 2/29/2016) 
in 26 selected state and local health departments, which collect 
information on persons diagnosed with, living with, and dying from HIV 
infection and AIDS.
    The participation of respondents is voluntary. There is no cost to 
the respondents other than their time. Through their participation, 
respondents will help to improve programs to prevent HIV infection as 
well as services for those who already have HIV.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average hours
      Type of respondent            Form name        Number of     responses per   per response    Total  burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Sampled, Eligible HIV-Infected  Interview                  8,720               1           45/60           6,540
 Persons.                        Questionnaire.
Facility office staff looking   ................           2,180               1            2/60              73
 up contact information.
Facility office staff           ................           1,090               1            5/60              91
 approaching sampled persons
 for enrollment.
Facility office staff pulling   ................           8,720               1            3/60             436
 medical records.
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           7,140
----------------------------------------------------------------------------------------------------------------


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. 2014-22010 Filed 9-15-14; 8:45 am]
BILLING CODE 4163-18-P
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