83 FR 53879 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 207 (October 25, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 207 (October 25, 2018)
| Page Range | 53879-53880 | |
| FR Document | 2018-23291 |
[Federal Register Volume 83, Number 207 (Thursday, October 25, 2018)] [Notices] [Pages 53879-53880] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-23291] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-19-0920] Agency Forms Undergoing Paperwork Reduction Act Review In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Data Collection Through Web Based Surveys for Evaluating Act Against AIDS Social Marketing Campaign Phases Targeting Consumers to the Office of Management and Budget (OMB) for review and approval. CDC previously published a ``Proposed Data Collection Submitted for Public Comment and Recommendations'' notice on June 6, 2018 to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected]. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication. Proposed Project Data Collection Through Web Based Surveys for Evaluating Act Against AIDS Social Marketing Campaign Phases Targeting Consumers (OMB #0920-0920, Exp. 6/30/2018)--Reinstatement with Change--National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description In response to the continued HIV epidemic in our country, CDC launched Act Against AIDS (AAA), a multifaceted communication campaign to reduce HIV incidence in the United States in 2009. CDC has released the campaign in phases, with some of the phases running concurrently. Each phase of the campaign uses mass media and direct-to-consumer channels to deliver messages. Some campaigns provide basic education and increase awareness of HIV/AIDS among the general public, whereas others emphasize HIV prevention and testing among specific subgroups or communities at greatest risk of infection. CDC will also develop new messages to address changes in prevention science and subpopulations affected by HIV. The proposed study will assess the effectiveness of these social marketing messages aimed at increasing HIV/AIDS awareness, increasing prevention behaviors, and improving HIV testing rates among consumers. The reinstatement with change of this ongoing study will allow for continued evaluation of the effectiveness of AAA social marketing campaign through surveys with consumers. A total of 10,750 respondents were approved for the previously renewed generic ICR (0920-0920) and since the approval date, 4,305 respondents were surveyed under the GenIC, ``Development of Messages for the Act Against AIDS National Testing''. The information collected from these data collections was used to evaluate a specific AAA campaign phase. We are requesting the same amount of time to continue surveying AAA target audiences as new phases are developed. Through the continuation of this collection, we plan to reach the remaining approved 6,445 respondents. To obtain the remaining respondents, we anticipate screening approximately 32,220 individuals. Depending on the target audience for the campaign phase, the study screener will vary. The study screener may address one or more of the following items: Race/ethnicity, sexual behavior, sexual orientation, gender identity, HIV testing history, HIV status, and injection drug use. Each survey will have a core set of items asked in all rounds, as well as a module of questions relating to specific AAA phases and activities. Respondents will be recruited through national opt-in email lists, the internet, and external partnerships with community-based and membership organizations that work with or represent individuals from targeted populations (e.g., National Urban League, the National Medical Association). Respondents will self-administer the survey at home on personal computers. There is no cost to the respondents other than their time. The total annualized burden hours are 1,432. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response respondents respondent (in hours) ---------------------------------------------------------------------------------------------------------------- Individuals (male and female) aged 18 Study Screener.......... 10,740 1 2/60 years and older. Survey.................. 2,148 1 30/60 ---------------------------------------------------------------------------------------------------------------- [[Page 53880]] Jeffrey M. Zirger, 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. 2018-23291 Filed 10-24-18; 8:45 am] BILLING CODE 4163-18-P
![Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices 53879
Jeffrey M. Zirger, (d) Minimize the burden of the collection will assess the effectiveness of these
Acting Chief, Information Collection Review of information on those who are to respond, social marketing messages aimed at
Office, Office of Scientific Integrity, Office including, through the use of appropriate increasing HIV/AIDS awareness,
of the Associate Director for Science, Office automated, electronic, mechanical, or other increasing prevention behaviors, and
of the Director, Centers for Disease Control technological collection techniques or other
forms of information technology, e.g.,
improving HIV testing rates among
and Prevention. consumers.
permitting electronic submission of
[FR Doc. 2018–23293 Filed 10–24–18; 8:45 am]
responses; and The reinstatement with change of this
BILLING CODE 4163–18–P (e) Assess information collection costs. ongoing study will allow for continued
To request additional information on evaluation of the effectiveness of AAA
the proposed project or to obtain a copy social marketing campaign through
DEPARTMENT OF HEALTH AND
of the information collection plan and surveys with consumers. A total of
HUMAN SERVICES
instruments, call (404) 639–7570 or 10,750 respondents were approved for
Centers for Disease Control and send an email to omb@cdc.gov. Direct the previously renewed generic ICR
Prevention written comments and/or suggestions (0920–0920) and since the approval
regarding the items contained in this date, 4,305 respondents were surveyed
[30Day–19–0920] under the GenIC, ‘‘Development of
notice to the Attention: CDC Desk
Officer, Office of Management and Messages for the Act Against AIDS
Agency Forms Undergoing Paperwork National Testing’’. The information
Reduction Act Review Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202) collected from these data collections
In accordance with the Paperwork 395–5806. Provide written comments was used to evaluate a specific AAA
Reduction Act of 1995, the Centers for within 30 days of notice publication. campaign phase. We are requesting the
Disease Control and Prevention (CDC) same amount of time to continue
has submitted the information Proposed Project surveying AAA target audiences as new
collection request titled Data Collection Data Collection Through Web Based phases are developed.
Through Web Based Surveys for Surveys for Evaluating Act Against Through the continuation of this
Evaluating Act Against AIDS Social AIDS Social Marketing Campaign collection, we plan to reach the
Marketing Campaign Phases Targeting Phases Targeting Consumers (OMB remaining approved 6,445 respondents.
Consumers to the Office of Management #0920–0920, Exp. 6/30/2018)— To obtain the remaining respondents,
and Budget (OMB) for review and Reinstatement with Change—National we anticipate screening approximately
approval. CDC previously published a Center for HIV/AIDS, Viral Hepatitis, 32,220 individuals. Depending on the
‘‘Proposed Data Collection Submitted STD and TB Prevention (NCHHSTP), target audience for the campaign phase,
for Public Comment and Centers for Disease Control and the study screener will vary. The study
Recommendations’’ notice on June 6, Prevention (CDC). screener may address one or more of the
2018 to obtain comments from the following items: Race/ethnicity, sexual
public and affected agencies. CDC Background and Brief Description behavior, sexual orientation, gender
received one comment related to the In response to the continued HIV identity, HIV testing history, HIV status,
previous notice. This notice serves to epidemic in our country, CDC launched and injection drug use. Each survey will
allow an additional 30 days for public Act Against AIDS (AAA), a multifaceted have a core set of items asked in all
and affected agency comments. communication campaign to reduce HIV rounds, as well as a module of questions
CDC will accept all comments for this incidence in the United States in 2009. relating to specific AAA phases and
proposed information collection project. CDC has released the campaign in activities.
The Office of Management and Budget phases, with some of the phases running Respondents will be recruited through
is particularly interested in comments concurrently. Each phase of the national opt-in email lists, the internet,
that: campaign uses mass media and direct- and external partnerships with
(a) Evaluate whether the proposed to-consumer channels to deliver community-based and membership
collection of information is necessary for the messages. Some campaigns provide organizations that work with or
proper performance of the functions of the basic education and increase awareness represent individuals from targeted
agency, including whether the information of HIV/AIDS among the general public, populations (e.g., National Urban
will have practical utility; whereas others emphasize HIV League, the National Medical
(b) Evaluate the accuracy of the agencies prevention and testing among specific Association). Respondents will self-
estimate of the burden of the proposed
collection of information, including the
subgroups or communities at greatest administer the survey at home on
validity of the methodology and assumptions risk of infection. CDC will also develop personal computers. There is no cost to
used; new messages to address changes in the respondents other than their time.
(c) Enhance the quality, utility, and clarity prevention science and subpopulations The total annualized burden hours are
of the information to be collected; affected by HIV. The proposed study 1,432.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
daltland on DSKBBV9HB2PROD with NOTICES
Individuals (male and female) aged 18 years and older ........................... Study Screener ... 10,740 1 2/60
Survey ................. 2,148 1 30/60
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![53880 Federal Register / Vol. 83, No. 207 / Thursday, October 25, 2018 / Notices
Jeffrey M. Zirger, SUMMARY: The Food and Drug DEPARTMENT OF HEALTH AND
Acting Chief, Information Collection Review Administration (FDA) is announcing the HUMAN SERVICES
Office, Office of Scientific Integrity, Office issuance of a priority review voucher to
of the Associate Director for Science, Office the sponsor of a rare pediatric disease Food and Drug Administration
of the Director, Centers for Disease Control
and Prevention.
product application. The Federal Food, [Docket No. FDA–2018–D–3462]
Drug, and Cosmetic Act (FD&C Act), as
[FR Doc. 2018–23291 Filed 10–24–18; 8:45 am]
amended by the Food and Drug Verification Systems Under the Drug
BILLING CODE 4163–18–P Supply Chain Security Act for Certain
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award Prescription Drugs; Draft Guidance for
priority review vouchers to sponsors of Industry; Availability
DEPARTMENT OF HEALTH AND
HUMAN SERVICES approved rare pediatric disease product AGENCY: Food and Drug Administration,
applications that meet certain criteria. HHS.
Centers for Disease Control and FDA is required to publish notice of the ACTION: Notice of availability.
Prevention award of the priority review voucher.
FDA has determined that REVCOVI SUMMARY: The Food and Drug
Disease, Disability, and Injury (elapegademase-lvlr) Injection, Administration (FDA or Agency) is
Prevention and Control Special manufactured by Leadiant Bioscience announcing the availability of a draft
Emphasis Panel (SEP)—RFA–CE19– guidance for industry entitled
Inc., meets the criteria for a priority
001; Correction ‘‘Verification Systems Under the Drug
review voucher.
Supply Chain Security Act for Certain
Notice is hereby given of a change in FOR FURTHER INFORMATION CONTACT: Prescription Drugs.’’ The draft guidance
the meeting of the Disease, Disability, Althea Cuff, Center for Drug Evaluation addresses the verification systems that
and Injury Prevention and Control manufacturers, repackagers, wholesale
and Research, Food and Drug
Special Emphasis Panel (SEP)—RFA– distributors, and dispensers must have
Administration, 10903 New Hampshire
CE19–001; October 30–November 2, in place to comply with the Federal
Ave., Silver Spring, MD 20993–0002,
2018, 8:30 a.m.–5:00 p.m., EDT which Food, Drug, and Cosmetic Act (FD&C
301–796–4061, Fax: 301–796–9856,
was published in the Federal Register Act), as amended by the Drug Supply
on August 23, 2018 Volume 83, Number email: althea.cuff@fda.hhs.gov.
Chain Security Act (DSCSA).
164, pages 42655–42656. SUPPLEMENTARY INFORMATION: FDA is Specifically, this draft guidance covers
The date should read as follows: announcing the issuance of a priority the statutory verification system
October 29, 2018, 3:00 p.m.–5:00 p.m., review voucher to the sponsor of an requirements that include quarantine
EDT, October 30–November 2, 2018, approved rare pediatric disease product and investigation of a product
8:00 a.m.–5:00 p.m., EDT. application. Under section 529 of the determined to be suspect and
FOR FURTHER INFORMATION CONTACT: FD&C Act (21 U.S.C. 360ff), which was quarantine and disposition of a product
Mikel L. Walters, M.A., Ph.D., Scientific added by FDASIA, FDA will award determined to be illegitimate. The draft
Review Official, NCIPC, CDC, 4770 priority review vouchers to sponsors of guidance also addresses the statutory
Buford Highway NE, Mailstop F–63, approved rare pediatric disease product requirement for notification to the
Atlanta, Georgia 30341, (404)639–0913; applications that meet certain criteria. Agency of a product that has been
mwalters@cdc.gov. FDA has determined that REVCOVI cleared by a manufacturer, repackager,
The Chief Operating Officer, Centers (elapegademase-lvlr) Injection, wholesale distributor, or dispenser after
for Disease Control and Prevention, has manufactured by Leadiant Bioscience a suspect product investigation because
been delegated the authority to sign Inc., meets the criteria for a priority it is determined that the product is not
Federal Register notices pertaining to review voucher. REVCOVI an illegitimate product.
announcements of meetings and other (elapegademase-lvlr) Injection is DATES: Submit either electronic or
committee management activities, for indicated for the treatment of Adenosine written comments on the draft guidance
both the Centers for Disease Control and Deaminase-Severe Combined by December 24, 2018 to ensure that the
Prevention and the Agency for Toxic Immunodeficiency (ADA–SCID) in Agency considers your comment on this
Substances and Disease Registry. draft guidance before it begins work on
pediatric and adult patients.
Sherri Berger, the final version of the guidance.
For further information about the Rare
Chief Operating Officer, Centers for Disease Pediatric Disease Priority Review ADDRESSES: You may submit comments
Control and Prevention. Voucher Program and for a link to the on any guidance at any time as follows:
[FR Doc. 2018–23297 Filed 10–24–18; 8:45 am] full text of section 529 of the FD&C Act, Electronic Submissions
BILLING CODE 4163–18–P go to https://www.fda.gov/ForIndustry/ Submit electronic comments in the
DevelopingProductsforRareDiseases following way:
DEPARTMENT OF HEALTH AND
Conditions/RarePediatricDiseasePriority • Federal eRulemaking Portal:
VoucherProgram/default.htm. For https://www.regulations.gov. Follow the
HUMAN SERVICES
further information about REVCOVI instructions for submitting comments.
Food and Drug Administration (elapegademase-lvlr) Injection, go to the Comments submitted electronically,
‘‘Drugs@FDA’’ website at https:// including attachments, to https://
[Docket No. FDA–2018–N–1262] www.accessdata.fda.gov/scripts/cder/ www.regulations.gov will be posted to
daltland on DSKBBV9HB2PROD with NOTICES
daf/. the docket unchanged. Because your
Issuance of Priority Review Voucher; comment will be made public, you are
Rare Pediatric Disease Product Dated: October 22, 2018.
solely responsible for ensuring that your
Leslie Kux,
AGENCY: Food and Drug Administration, comment does not include any
Associate Commissioner for Policy. confidential information that you or a
HHS.
[FR Doc. 2018–23308 Filed 10–24–18; 8:45 am] third party may not wish to be posted,
ACTION: Notice.
BILLING CODE 4164–01–P such as medical information, your or
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Document Created: 2018-10-25 01:45:44
Document Modified: 2018-10-25 01:45:44
| 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 | |
| FR Citation | 83 FR 53879 |
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