81 FR 43204 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 127 (July 1, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 127 (July 1, 2016)
| Page Range | 43204-43206 | |
| FR Document | 2016-15646 |
[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)] [Notices] [Pages 43204-43206] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-15646] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-16ATI; Docket No. CDC-2016-0057] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. ----------------------------------------------------------------------- SUMMARY: The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, 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. This notice invites comment on Development of CDC's Act Against AIDS Social Marketing Campaigns Targeting Consumers. CDC is requesting approval for revision to the previously approved project to continue testing HIV/AIDS prevention and treatment messages to be included in social marketing campaigns targeting consumers. DATES: Written comments must be received on or before August 30, 2016. ADDRESSES: You may submit comments, identified by Docket No. CDC-2016- 0057 by any of the following methods:Federal eRulemaking Portal: Regulation.gov. Follow the instructions for submitting comments. Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329. Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov. Please note: All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above. [[Page 43205]] FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS- D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. 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. Proposed Project Development of CDC's Act Against AIDS Social Marketing Campaigns Targeting Consumers--New--National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC) Background and Brief Description In an effort to refocus attention on domestic HIV and AIDS, CDC launched the Act Against AIDS (AAA) initiative in 2009 with the White House and the U.S. Department of Health and Human Services. AAA is a multifaceted national communication initiative that supports reduction of HIV incidence in the U.S. through multiple, concurrent communication and education campaigns for a variety of audiences including, the general public, populations most affected by HIV and health care providers. The campaigns target consumers 18-64 years old and include the following audiences: (1) Men who have sex with men (MSM) of all races; (2) Blacks/African Americans; (3) Hispanics/Latinos; (4) Transgender individuals; (5) HIV-positive individuals; and (6) national audience of all races. All campaigns support the comprehensive HIV prevention efforts of CDC and the National HIV/AIDS Strategy (NHAS). The goal of this study is to qualitatively test messages and materials that will be used in specific HIV social marketing campaigns under the AAA initiative that target consumers in order to increase HIV testing rates, increase HIV awareness and knowledge, challenge commonly held misperceptions about HIV, and promote HIV prevention and risk reduction. The intended use of the resulting data is for CDC to revise and/or develop timely, relevant, clear, and engaging materials for these social marketing campaigns. Qualitative methods will be used to collect the data include focus groups, intercept interviews, and in-depth interviews. Qualitative methods provide flexible in-depth exploration of the participants' perceptions and experience; and the interviews yield descriptions in the participants' own words. Qualitative methods also allow the interviewer flexibility to pursue relevant and important issues as they arise during the discussion. The participants will also participate in a brief 15-minute brief survey. Data collected by the brief survey will provide a source of quantitative data supplementing the qualitative data collected during the interviews. The brief survey will be administered to participants before the individual in-depth interview and focus group. The survey will collect basic background information about the participants' knowledge, attitudes and beliefs about HIV, HIV testing behaviors, risk behaviors and demographics to enable us to more fully describe the participants. There is no cost to participants other than their time. The total estimated annualized burden hours are 2,063. Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total burden Respondents Form name respondents responses per response (in hours respondent hours) -------------------------------------------------------------------------------------------------------------------------------------------------------- Individuals (males and females) aged 18-64..... Study screener......................... 2338 1 2/60 78 Exploratory--HIV Testing In-depth 74 1 1 74 Interview Guide. Exploratory--HIV Prevention In-depth 74 1 1 74 Interview Guide. Exploratory--HIV Communication and 74 1 1 74 Awareness In-depth Interview Guide. Exploratory--HIV Prevention with 74 1 1 74 Positives In-depth Interview Guide. Consumer Message Testing In-depth 68 1 1 68 Interview Guide. [[Page 43206]] Consumer Concept Testing In-depth 68 1 1 68 Interview Guide. Consumer Materials Testing In-depth 68 1 1 68 Interview Guide. Exploratory--HIV Testing Focus Group 74 1 2 148 Interview Guide. Exploratory--HIV Prevention Focus Group 74 1 2 148 Interview Guide. Exploratory--HIV Communication and 74 1 2 148 Awareness Focus Group Interview Guide. Exploratory--HIV Prevention with 74 1 2 148 Positives Focus Group Interview Guide. Consumer Concept Testing Focus Group 68 1 2 136 Interview Guide. Consumer Message Testing Focus Group 68 1 2 136 Interview Guide. Consumer Materials Testing Focus Group 68 1 2 136 Interview Guide. HIV Testing Survey..................... 250 1 15/60 63 HIV Prevention Survey.................. 250 1 15/60 63 HIV Communication and Awareness Survey. 250 1 15/60 63 HIV Prevention with Positives Survey... 250 1 15/60 63 Intercept Interview Guide.............. 700 1 20/60 233 --------------------------------------------------------------- Total...................................... ....................................... .............. .............. .............. 2,063 -------------------------------------------------------------------------------------------------------------------------------------------------------- Jeffrey M. Zirger, Health Scientist, Acting 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. 2016-15646 Filed 6-30-16; 8:45 am] BILLING CODE 4163-18-P
![43204 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
Proposed Project infections in recent contacts of cases secure web-based system for program
and in other persons likely to be evaluation data, in 2010. No other
Aggregate Reports for Tuberculosis
infected and providing therapy for federal agency collects this type of
Program Evaluation (0920–0457—Exp.
latent tuberculosis infection. In 2000, national tuberculosis data, and the
9–30–2016)—Extension—National
CDC implemented two program Aggregate report of follow-up for
Center for HIV/AIDS, Viral Hepatitis, evaluation reports for annual
STD, and TB Prevention (NCHHSTP), contacts of tuberculosis, and Aggregate
submission: Aggregate report of follow- report of screening and preventive
Centers for Disease Control and up for contacts of tuberculosis, and
Prevention (CDC) therapy for tuberculosis infection are
Aggregate report of screening and the only data source about latent
Background and Brief Description preventive therapy for tuberculosis
tuberculosis infection for monitoring
infection (OMB No. 0920–0457). The
CDC requests the extension of the national progress toward tuberculosis
respondents for these reports are the 68
Aggregate Reports for Tuberculosis state and local tuberculosis control elimination with these activities. CDC
Program Evaluation, previously programs receiving federal cooperative provides ongoing assistance in the
approved under OMB No. 0920–0457 agreement funding through the CDC preparation and utilization of these
for 3-years. There are no revisions to the Division of Tuberculosis Elimination reports at the local and state levels of
report forms, data definitions, or (DTBE). These reports emphasize public health jurisdiction. CDC also
reporting instructions. treatment outcomes, high-priority target provides respondents with technical
To ensure the elimination of populations vulnerable to tuberculosis, support for the NTIP software
tuberculosis in the United States, CDC and programmed electronic report entry, (Electronic—100%, Use of Electronic
monitors indicators for key program which transitioned to the National Signatures—No). There is no cost to
activities, such as finding tuberculosis Tuberculosis Indicators Project (NTIP), a respondents.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of Total
Number of burden per
Type of respondent Form name responses per burden
respondents response
respondent hours
(in hours)
Data clerks and Program Managers, elec- Follow-up and Treatment of Contacts to 100 1 30/60 50
tronic. Tuberculosis Cases Form (Att 3a).
Program Managers, manual ..................... Follow-up and Treatment of Contacts to 18 1 30/60 9
Tuberculosis Cases Form (Att 3a).
Data clerks, (manual) ................................ Follow-up and Treatment of Contacts to 18 1 3 54
Tuberculosis Cases Form (Att 3a).
Data clerks and Program Managers, elec- Targeted Testing and Treatment for La- 100 1 30/60 50
tronic. tent Tuberculosis Infection (Att 3b).
Program Managers, (manual) ................... Targeted Testing and Treatment for La- 18 1 30/60 9
tent Tuberculosis Infection (Att 3b).
Data clerks, (manual) ................................ Targeted Testing and Treatment for La- 18 1 3 54
tent Tuberculosis Infection (Att 3b).
Total ................................................... ................................................................... .................... ........................ .................... 226
Jeffrey M. Zirger, ACTION: Notice with comment period. ADDRESSES: You may submit comments,
Health Scientist, Acting Chief, Information identified by Docket No. CDC–2016–
Collection Review Office, Office of Scientific SUMMARY: The Centers for Disease 0057 by any of the following methods:
Integrity, Office of the Associate Director for Control and Prevention (CDC), as part of • Federal eRulemaking Portal:
Science, Office of the Director, Centers for its continuing efforts to reduce public
Disease Control and Prevention. Regulation.gov. Follow the instructions
burden and maximize the utility of for submitting comments.
[FR Doc. 2016–15647 Filed 6–30–16; 8:45 am] government information, invites the • Mail: Leroy A. Richardson,
BILLING CODE 4163–18–P general public and other Federal Information Collection Review Office,
agencies to take this opportunity to Centers for Disease Control and
comment on proposed and/or Prevention, 1600 Clifton Road NE., MS–
DEPARTMENT OF HEALTH AND continuing information collections, as
HUMAN SERVICES D74, Atlanta, Georgia 30329.
required by the Paperwork Reduction
Act of 1995. This notice invites Instructions: All submissions received
Centers for Disease Control and must include the agency name and
Prevention comment on Development of CDC’s Act
Against AIDS Social Marketing Docket Number. All relevant comments
Campaigns Targeting Consumers. CDC received will be posted without change
[60Day–16–16ATI; Docket No. CDC–2016– to Regulations.gov, including any
asabaliauskas on DSK3SPTVN1PROD with NOTICES
0057] is requesting approval for revision to the
previously approved project to continue personal information provided. For
Proposed Data Collection Submitted testing HIV/AIDS prevention and access to the docket to read background
for Public Comment and treatment messages to be included in documents or comments received, go to
Recommendations social marketing campaigns targeting Regulations.gov.
consumers. Please note: All public comment should be
AGENCY: Centers for Disease Control and submitted through the Federal eRulemaking
Prevention (CDC), Department of Health DATES: Written comments must be portal (Regulations.gov) or by U.S. mail to the
and Human Services (HHS). received on or before August 30, 2016. address listed above.
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![43206 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden per Total burden
Respondents Form name responses per
respondents response hours
respondent (in hours)
Consumer Concept Testing In-depth Interview 68 1 1 68
Guide.
Consumer Materials Testing In-depth Interview 68 1 1 68
Guide.
Exploratory—HIV Testing Focus Group Inter- 74 1 2 148
view Guide.
Exploratory—HIV Prevention Focus Group Inter- 74 1 2 148
view Guide.
Exploratory—HIV Communication and Aware- 74 1 2 148
ness Focus Group Interview Guide.
Exploratory—HIV Prevention with Positives 74 1 2 148
Focus Group Interview Guide.
Consumer Concept Testing Focus Group Inter- 68 1 2 136
view Guide.
Consumer Message Testing Focus Group Inter- 68 1 2 136
view Guide.
Consumer Materials Testing Focus Group Inter- 68 1 2 136
view Guide.
HIV Testing Survey ............................................. 250 1 15/60 63
HIV Prevention Survey ........................................ 250 1 15/60 63
HIV Communication and Awareness Survey ...... 250 1 15/60 63
HIV Prevention with Positives Survey ................. 250 1 15/60 63
Intercept Interview Guide .................................... 700 1 20/60 233
Total ........................ .............................................................................. ........................ ........................ ........................ 2,063
Jeffrey M. Zirger, products (LBPs) in the United States. identifies you in the body of your
Health Scientist, Acting Chief, Information The guidance announced in this notice comments, that information will be
Collection Review Office, Office of Scientific updates the guidance of the same title posted on http://www.regulations.gov.
Integrity, Office of the Associate Director for dated February 2012 (February 2012 • If you want to submit a comment
Science, Office of the Director, Centers for guidance) by addressing when the label with confidential information that you
Disease Control and Prevention. on the commercially available do not wish to be made available to the
[FR Doc. 2016–15646 Filed 6–30–16; 8:45 am] products(s) would be considered public, submit the comment as a
BILLING CODE 4163–18–P adequate to satisfy the purpose of the written/paper submission and in the
chemistry, manufacturing, and control manner detailed (see ‘‘Written/Paper
(CMC) information requirements. Submissions’’ and ‘‘Instructions’’).
DEPARTMENT OF HEALTH AND
DATES: Submit either electronic or Written/Paper Submissions
HUMAN SERVICES
written comments on Agency guidances
Submit written/paper submissions as
Food and Drug Administration at any time. follows:
[Docket No. FDA–2010–D–0500]
ADDRESSES: You may submit comments • Mail/Hand delivery/Courier (for
as follows: written/paper submissions): Division of
Early Clinical Trials With Live Electronic Submissions Dockets Management (HFA–305), Food
Biotherapeutic Products: Chemistry, and Drug Administration, 5630 Fishers
Submit electronic comments in the Lane, Rm. 1061, Rockville, MD 20852.
Manufacturing, and Control
Information; Guidance for Industry;
following way: • For written/paper comments
• Federal eRulemaking Portal: http:// submitted to the Division of Dockets
Availability
www.regulations.gov. Follow the Management, FDA will post your
AGENCY: Food and Drug Administration, instructions for submitting comments. comment, as well as any attachments,
HHS. Comments submitted electronically, except for information submitted,
ACTION: Notice of availability. including attachments, to http:// marked and identified, as confidential,
www.regulations.gov will be posted to if submitted as detailed in
SUMMARY: The Food and Drug the docket unchanged. Because your ‘‘Instructions.’’
Administration (FDA or Agency) is comment will be made public, you are Instructions: All submissions received
announcing the availability of a solely responsible for ensuring that your must include the Docket No. FDA–
document entitled ‘‘Early Clinical Trials comment does not include any 2010–D–0500 for ‘‘Early Clinical Trials
asabaliauskas on DSK3SPTVN1PROD with NOTICES
With Live Biotherapeutic Products: confidential information that you or a With Live Biotherapeutic Products:
Chemistry, Manufacturing, and Control third party may not wish to be posted, Chemistry, Manufacturing, and Control
Information; Guidance for Industry.’’ such as medical information, your or Information; Guidance for Industry.’’
The guidance document provides anyone else’s Social Security number, or Received comments will be placed in
investigational new drug application confidential business information, such the docket and, except for those
(IND) sponsors with recommendations as a manufacturing process. Please note submitted as ‘‘Confidential
regarding IND submissions for early that if you include your name, contact Submissions,’’ publicly viewable at
clinical trials with live biotherapeutic information, or other information that http://www.regulations.gov or at the
VerDate Sep<11>2014 19:05 Jun 30, 2016 Jkt 238001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\01JYN1.SGM 01JYN1](https://thefederalregister.org/doc/81_FR_43331/page/3.svg)
Document Created: 2016-07-14 11:37:23
Document Modified: 2016-07-14 11:37:23
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | Written comments must be received on or before August 30, 2016. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS- D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected] | |
| FR Citation | 81 FR 43204 |
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