The Biomedical Advanced Research and Development Authority (BARDA), 40303 [2018-17381]

Download as PDF amozie on DSK3GDR082PROD with NOTICES1 Federal Register / Vol. 83, No. 157 / Tuesday, August 14, 2018 / Notices Print Format in Direct-to-Consumer Prescription Drug Advertisements on Risk Knowledge and Preference.’’ Drug Information Journal, vol. 36(3), pp. 693– 705, 2002. 7. Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs. Revised Draft Guidance. Available at https:// www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory Information/Guidances/UCM069984.pdf. 8. ‘‘Content of Risk Information in the Major Statement in Prescription Drug Direct-toConsumer Broadcast Advertisements; Establishment of a Public Docket; Request for Information and Comments.’’ August 21, 2017, 82 FR 39598. 9. Betts, Kevin R., et al., ‘‘Serious and Actionable Risks, Plus Disclosure: Investigating an Alternative Approach for Presenting Risk Information in Prescription Drug Television Advertisements.’’ Research in Social and Administrative Pharmacy, 2017. 10. Bhutada, N.S., B.L. Rollins, and M. Perri III, ‘‘Impact of Animated SpokesCharacters in Print Direct-to-Consumer Prescription Drug Advertising: An Elaboration Likelihood Model Approach.’’ Health Communication, vol. 32, pp. 391–400, 2017. 11. Zaichkowsky, J.L., ‘‘The Personal Involvement inventory: Reduction, Revision, and Application to Advertising.’’ Journal of Advertising, vol. 23, pp. 59–70, 1994. 12. Mackert, M., S.E. Champlin, K.E. Pasch, and B.D. Weiss, ‘‘Understanding Health Literacy Measurement Through Eye Tracking.’’ Journal of Health Communication, vol. 18, pp. 185–196, 2013. 13. Chiang, K.P. and A. Jackson, ‘‘The Impact of Health Literacy on Involvement and Attitude Toward Pharmaceutical Print Ads.’’ International Journal of Healthcare Management, vol. 9(1), pp. 47–57, 2016. 14. An, S. and N. Muturi, ‘‘Subjective Health Literacy and Older Adults’ Assessment of Direct-to Consumer Prescription Drug Ads.’’ Journal of Health Communication, vol. 16(3), pp. 242–255, 2011. 15. Ball, J.G., D. Manika, and P. Stout, ‘‘Consumers Young and Old: Segmenting the Target Markets for Direct-toConsumer Prescription Drug Advertising.’’ Health Marketing Quarterly, vol. 28(4), pp. 337–353, 2011. 16. Christensen, T.P., F.J. Ascione, and R.P. Bagozzi, ‘‘Understanding How Elderly Patients Process Drug Information: A Test of a Theory of Information Processing.’’ Pharmaceutical Research, vol. 14, pp. 1589–1596, 1997. 17. Mehta, A. and S.C. Purvis, ‘‘Consumer Response to Print Prescription Drug Advertising.’’ Journal of Advertising Research, vol. 43(2), pp. 194–206, 2003. 18. Paulhus, D.L. and S. Vazire, ‘‘The SelfReport Method.’’ Handbook of Research Methods in Personality Psychology, vol. 1, pp. 224–239, 2007. VerDate Sep<11>2014 19:13 Aug 13, 2018 Jkt 244001 Dated: August 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–17360 Filed 8–13–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES The Biomedical Advanced Research and Development Authority (BARDA) Assistant Secretary for Preparedness and Response, HHS. ACTION: Notice. AGENCY: The Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), in the Department of Health and Human Services intends to provide a Single Source Cooperative Agreement to Janssen Research & Development, LLC. The Cooperative Agreement will support QuickFire Challenges to spur innovation in respiratory protection. The total proposed cost of the Single Source Cooperative Agreement is not to exceed $100,000 for a total of 12 months. DATES: Project Period: The period of performance is from July 30, 2018 to June 30, 2019. Award amount: Estimate $100,000. FOR FURTHER INFORMATION CONTACT: Sherrette.Funn@hhs.gov, 202–795–7714, Julie.Schafer@hhs.gov, 202–205–1435. SUPPLEMENTARY INFORMATION: The Biomedical Advanced Research and Development Authority (BARDA) is the program office for this Cooperative Agreement: Single Source Justification: Janssen Research & Development, LLC creates global challenges to spur innovation in health care in partnership with JLABS, a global network of open innovation ecosystems designed to support innovators and entrepreneurs in creating and accelerating innovative health care solutions. Janssen Research & Development, LLC and BARDA will collaborate on a global challenge for reimagined, transformative respiratory protection. Traditional respiratory protective devices used to protect against inhalation of harmful infectious agents were designed for use in occupational settings, to guard against inhalation of dangerous particulates. Disposable versions, such as N95 respirators, are only available for adults, must be fit-tested to ensure proper functioning, and can be uncomfortable to wear. In an outbreak of a novel or newly emerging respiratory SUMMARY: PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 40303 disease, respiratory protection may be the only countermeasure available to protect health care workers and the general public. Janssen Research & Development, LLC will partner with JLABS, which exists to foster innovation in health care products and executes QuickFire Challenges for health care innovation. There is no direct equivalent of the QuickFire Challenge services for innovation specific to health care as is provided by JLABS. Its unique service will directly benefit BARDA’s mission to make available medical countermeasures to address health security threats. Supporting innovation is an authority provided to BARDA under the Public Health Service Act and partnering with a company providing a diverse array of products and leveraging its expertise and infrastructure has the potential to provide solutions to the challenges in developing new respiratory devices. Reimagined, innovative respiratory protection would contribute directly to ASPR’s mission to save lives and protect Americans against 21st Century health security threats. Respiratory protection is often the first line of defense, and a radically improved approach to protect both health care workers and the general public, including children, would truly improve our ability to respond to public health emergencies. By generating interest and focusing innovation efforts on reimagining respiratory protection, BARDA’s goal for the QuickFire Challenge is for the resulting innovative approaches to be eligible for continued testing and development and eventual regulatory approval, so that these revolutionary products can be widely available and used. Please submit an inquiry via the ASPR–BARDA Program Contact: Dr. Julie Schafer, Julie.Schafer@hhs.gov, 202–205–1435. Robert P. Kadlec, Assistant Secretary for Preparedness and Response. [FR Doc. 2018–17381 Filed 8–13–18; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Pain Management Best Practices Inter-Agency Task Force Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: E:\FR\FM\14AUN1.SGM 14AUN1

Agencies

[Federal Register Volume 83, Number 157 (Tuesday, August 14, 2018)]
[Notices]
[Page 40303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17381]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES


The Biomedical Advanced Research and Development Authority 
(BARDA)

AGENCY: Assistant Secretary for Preparedness and Response, HHS.

ACTION: Notice.

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

SUMMARY: The Biomedical Advanced Research and Development Authority 
(BARDA), Office of the Assistant Secretary for Preparedness and 
Response (ASPR), in the Department of Health and Human Services intends 
to provide a Single Source Cooperative Agreement to Janssen Research & 
Development, LLC. The Cooperative Agreement will support QuickFire 
Challenges to spur innovation in respiratory protection. The total 
proposed cost of the Single Source Cooperative Agreement is not to 
exceed $100,000 for a total of 12 months.

DATES: 
    Project Period: The period of performance is from July 30, 2018 to 
June 30, 2019.
    Award amount: Estimate $100,000.

FOR FURTHER INFORMATION CONTACT: [email protected], 202-795-7714, 
[email protected], 202-205-1435.

SUPPLEMENTARY INFORMATION: The Biomedical Advanced Research and 
Development Authority (BARDA) is the program office for this 
Cooperative Agreement:
    Single Source Justification: Janssen Research & Development, LLC 
creates global challenges to spur innovation in health care in 
partnership with JLABS, a global network of open innovation ecosystems 
designed to support innovators and entrepreneurs in creating and 
accelerating innovative health care solutions.
    Janssen Research & Development, LLC and BARDA will collaborate on a 
global challenge for reimagined, transformative respiratory protection. 
Traditional respiratory protective devices used to protect against 
inhalation of harmful infectious agents were designed for use in 
occupational settings, to guard against inhalation of dangerous 
particulates. Disposable versions, such as N95 respirators, are only 
available for adults, must be fit-tested to ensure proper functioning, 
and can be uncomfortable to wear. In an outbreak of a novel or newly 
emerging respiratory disease, respiratory protection may be the only 
countermeasure available to protect health care workers and the general 
public.
    Janssen Research & Development, LLC will partner with JLABS, which 
exists to foster innovation in health care products and executes 
QuickFire Challenges for health care innovation. There is no direct 
equivalent of the QuickFire Challenge services for innovation specific 
to health care as is provided by JLABS. Its unique service will 
directly benefit BARDA's mission to make available medical 
countermeasures to address health security threats. Supporting 
innovation is an authority provided to BARDA under the Public Health 
Service Act and partnering with a company providing a diverse array of 
products and leveraging its expertise and infrastructure has the 
potential to provide solutions to the challenges in developing new 
respiratory devices.
    Reimagined, innovative respiratory protection would contribute 
directly to ASPR's mission to save lives and protect Americans against 
21st Century health security threats. Respiratory protection is often 
the first line of defense, and a radically improved approach to protect 
both health care workers and the general public, including children, 
would truly improve our ability to respond to public health 
emergencies. By generating interest and focusing innovation efforts on 
reimagining respiratory protection, BARDA's goal for the QuickFire 
Challenge is for the resulting innovative approaches to be eligible for 
continued testing and development and eventual regulatory approval, so 
that these revolutionary products can be widely available and used.
    Please submit an inquiry via the ASPR-BARDA Program Contact: Dr. 
Julie Schafer, [email protected], 202-205-1435.

Robert P. Kadlec,
Assistant Secretary for Preparedness and Response.
[FR Doc. 2018-17381 Filed 8-13-18; 8:45 am]
 BILLING CODE 4150-28-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.