Att 2_Published 60d FRN

55496

Federal Register / Vol. 79, No. 179 / Tuesday, September 16, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
hours

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]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

tkelley on DSK3SPTVN1PROD with NOTICES

Number of
respondents

Type of respondent

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

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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

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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
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

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

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:

FOR FURTHER INFORMATION CONTACT:

[Docket No. FDA–2014–D–1288]
tkelley on DSK3SPTVN1PROD with NOTICES

Number of
responses per
respondent

Number of
respondents

Type of respondent

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Frm 00072

Fmt 4703

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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

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