Draft Guidance for Industry: Electronic Submission of Lot Distribution Reports; Availability; Correction, 55497 [2014-22015]

Download as PDF 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]
[Page 55497]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22015]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[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: Notice; correction.

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

SUMMARY: 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.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, August 
29, 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

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