Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of Participants of an Annual SMP/SHIP National Training Conference Hosted by the Office of Healthcare Information and Counseling [OMB #0985-New], 37952-37953 [2020-13575]

Download as PDF 37952 Federal Register / Vol. 85, No. 122 / Wednesday, June 24, 2020 / Notices Number of respondents (minimum) Respondent/data collection activity Hours per response Annual burden hours Survey, Stratified Random Sample ......................................................... 600 1 5/60 50 Total .................................................................................................. 600 1 5/60 50 Number of respondents (maximum) Respondent/data collection activity Responses per respondent Hours per response Annual burden hours Survey, Stratified Random Sample ......................................................... 5,400 1 5/60 450 Total .................................................................................................. 5,400 1 5/60 450 Dated: June 17, 2020. Mary Lazare, Principal Deputy Administrator. [FR Doc. 2020–13576 Filed 6–23–20; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of Participants of an Annual SMP/SHIP National Training Conference Hosted by the Office of Healthcare Information and Counseling [OMB #0985–New] Administration for Community Living, HHS. ACTION: Notice AGENCY: The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to Proposed new information collection requirements related to Evaluation of participants of an Annual SMP/SHIP National Training Conference hosted by the Office of Healthcare Information and Counseling. DATES: Submit written comments on the collection of information by July 24, 2020. ADDRESSES: Submit electronic comments on the collection of information by: (a) Email to: OIRA_submission@ omb.eop.gov, Attn: OMB Desk Officer for ACL; (b) fax to 202.395.5806, Attn: OMB Desk Officer for ACL; or SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES Responses per respondent VerDate Sep<11>2014 18:20 Jun 23, 2020 Jkt 250001 (c) by mail to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW, Rm. 10235, Washington, DC 20503, Attn: OMB Desk Officer for ACL. FOR FURTHER INFORMATION CONTACT: Marissa Whitehouse, Administration for Community Living, Washington, DC 20201, Marissa.Whitehouse@acl.hhs.gov or 202–795–7425. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, ACL has submitted the following proposed collection of information to OMB for review and clearance. The Office of Healthcare Information and Counseling (OHIC) hosts an annual national training conference for the federally funded programs that it administers. The audience for this training conference includes attendees from State Health Insurance Assistance Program (SHIP) and Senior Medicare Patrol (SMP) programs, which are two nationally recognized programs that provide Medicare information and counseling to Medicare beneficiaries and help, fight Medicare fraud through prevention and education. Grantee leadership is required to attend this training annually to ensure they receive critical information and technical assistance needed to help them successfully meet the requirements of their grant awards. Grantees are encouraged to bring up to three (3) people from each program. Programs operate in each of the 50 states, the District of Columbia, Guam, Puerto Rico, and the US Virgin Islands. The information collected in this survey is necessary to ensure that ACL is meeting the technical assistance needs of the attendees and to capture valuable feedback to be used for future training meetings. By gathering feedback on the quality of the training and content provided, we can ensure attendee satisfaction and gather information for PO 00000 Frm 00133 Fmt 4703 Sfmt 4703 future planning. ACL administers a contract to develop and provide the training conference evaluation tool for ACL’s approval. They also disseminate a tool to all participants following each training conference to evaluate attendee satisfaction. This training conference survey is introduced and explained during the program specific meetings and during the general session on the first day of the training conference. The survey is not mandatory, but is reinforced as a way for ACL to provide useful, engaging sessions that assist the attendees in successfully meeting the requirements of their grant awards. This evaluation tool will gather feedback on the quality of the training and content provided and the experience of the attendees to be used for future planning. Comments in Response to the 60-Day Federal Register Notice A 60-Day Notice s published in the Federal Register on February 7, 2020 Vol. 85 pages 7309–7310. ACL received one public comment during the 60-day public comment period; the public comment related to the current COVID– 19 pandemic requesting the 2020 event be held virtually. Though it is essential for this event to be held in-person and to bring together national partners from across the country each year, this year’s COVID–19 pandemic has halted all inperson event capability. ACL intends to hold the 2020 conference virtually. For review and comment on this proposed information collection request, please visit the ACL website https://www.acl.gov/about-acl/publicinput. Estimated Program Burden ACL estimates the burden associated with this collection of information as follows: E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 85, No. 122 / Wednesday, June 24, 2020 / Notices Number of respondents Respondent/data collection activity Conference Evaluation ...................................................................... Dated: June 17, 2020. Mary Lazare, Principal Deputy Administrator. [FR Doc. 2020–13575 Filed 6–23–20; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–P–0813] Determination That TENEX (Guanfacine Hydrochloride) Tablets, 1 Milligram, 2 Milligrams, and 3 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that TENEX (guanfacine hydrochloride) tablets, 1 milligram (mg), 2 mg, and 3 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. SUMMARY: jbell on DSKJLSW7X2PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Jessica Tierney, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993–0002, 301– 796–9120, Jessica.Tierney@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive VerDate Sep<11>2014 18:20 Jun 23, 2020 Jkt 250001 Responses per respondent Hours per response 1 15 minutes ............. 364 clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. TENEX (guanfacine hydrochloride) tablets, 1 mg, 2 mg, and 3 mg, is the subject of NDA 019032, held by Promius Pharma LLC, and initially approved on October 27, 1996. TENEX is indicated in the management of hypertension. TENEX (guanfacine hydrochloride) tablets, 1 mg, 2 mg, and 3 mg, is currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Unichem Pharmaceuticals (USA), Inc. submitted a citizen petition dated February 13, 2020 (Docket No. FDA– 2020–P–0813), under 21 CFR 10.30, requesting that the Agency determine whether TENEX (guanfacine hydrochloride) tablets, 1 mg and 2 mg, was withdrawn from sale for reasons of safety or effectiveness. Although the citizen petition did not address the 3 mg strength, that strength has also been discontinued. On our own initiative, we have also determined whether that strength was withdrawn for safety or effectiveness reasons. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that TENEX (guanfacine hydrochloride) tablets, 1 mg, 2 mg, and PO 00000 Frm 00134 Fmt 4703 Sfmt 9990 37953 Annual burden hours 91 3 mg, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that TENEX (guanfacine hydrochloride) tablets, 1 mg, 2 mg, and 3 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of TENEX (guanfacine hydrochloride) tablets, 1 mg, 2 mg, and 3 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list TENEX (guanfacine hydrochloride) tablets, 1 mg, 2 mg, and 3 mg, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: June 18, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–13594 Filed 6–23–20; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\24JNN1.SGM 24JNN1

Agencies

[Federal Register Volume 85, Number 122 (Wednesday, June 24, 2020)]
[Notices]
[Pages 37952-37953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13575]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Community Living


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Evaluation of Participants of an Annual SMP/SHIP 
National Training Conference Hosted by the Office of Healthcare 
Information and Counseling [OMB #0985-New]

AGENCY: Administration for Community Living, HHS.

ACTION: Notice

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

SUMMARY: The Administration for Community Living (ACL) is announcing 
that the proposed collection of information listed above has been 
submitted to the Office of Management and Budget (OMB) for review and 
clearance as required under section 506(c)(2)(A) of the Paperwork 
Reduction Act of 1995. This 30-Day notice collects comments on the 
information collection requirements related to Proposed new information 
collection requirements related to Evaluation of participants of an 
Annual SMP/SHIP National Training Conference hosted by the Office of 
Healthcare Information and Counseling.

DATES: Submit written comments on the collection of information by July 
24, 2020.

ADDRESSES: Submit electronic comments on the collection of information 
by:
    (a) Email to: [email protected], Attn: OMB Desk Officer 
for ACL;
    (b) fax to 202.395.5806, Attn: OMB Desk Officer for ACL; or
    (c) by mail to the Office of Information and Regulatory Affairs, 
OMB, New Executive Office Bldg., 725 17th St. NW, Rm. 10235, 
Washington, DC 20503, Attn: OMB Desk Officer for ACL.

FOR FURTHER INFORMATION CONTACT: Marissa Whitehouse, Administration for 
Community Living, Washington, DC 20201, [email protected] 
or 202-795-7425.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, ACL has 
submitted the following proposed collection of information to OMB for 
review and clearance. The Office of Healthcare Information and 
Counseling (OHIC) hosts an annual national training conference for the 
federally funded programs that it administers. The audience for this 
training conference includes attendees from State Health Insurance 
Assistance Program (SHIP) and Senior Medicare Patrol (SMP) programs, 
which are two nationally recognized programs that provide Medicare 
information and counseling to Medicare beneficiaries and help, fight 
Medicare fraud through prevention and education. Grantee leadership is 
required to attend this training annually to ensure they receive 
critical information and technical assistance needed to help them 
successfully meet the requirements of their grant awards.
    Grantees are encouraged to bring up to three (3) people from each 
program. Programs operate in each of the 50 states, the District of 
Columbia, Guam, Puerto Rico, and the US Virgin Islands. The information 
collected in this survey is necessary to ensure that ACL is meeting the 
technical assistance needs of the attendees and to capture valuable 
feedback to be used for future training meetings. By gathering feedback 
on the quality of the training and content provided, we can ensure 
attendee satisfaction and gather information for future planning. ACL 
administers a contract to develop and provide the training conference 
evaluation tool for ACL's approval. They also disseminate a tool to all 
participants following each training conference to evaluate attendee 
satisfaction. This training conference survey is introduced and 
explained during the program specific meetings and during the general 
session on the first day of the training conference. The survey is not 
mandatory, but is reinforced as a way for ACL to provide useful, 
engaging sessions that assist the attendees in successfully meeting the 
requirements of their grant awards. This evaluation tool will gather 
feedback on the quality of the training and content provided and the 
experience of the attendees to be used for future planning.

Comments in Response to the 60-Day Federal Register Notice

    A 60-Day Notice s published in the Federal Register on February 7, 
2020 Vol. 85 pages 7309-7310. ACL received one public comment during 
the 60-day public comment period; the public comment related to the 
current COVID-19 pandemic requesting the 2020 event be held virtually. 
Though it is essential for this event to be held in-person and to bring 
together national partners from across the country each year, this 
year's COVID-19 pandemic has halted all in-person event capability. ACL 
intends to hold the 2020 conference virtually.
    For review and comment on this proposed information collection 
request, please visit the ACL website https://www.acl.gov/about-acl/public-input.

Estimated Program Burden

    ACL estimates the burden associated with this collection of 
information as follows:

[[Page 37953]]



----------------------------------------------------------------------------------------------------------------
   Respondent/data collection        Number of      Responses per                                 Annual burden
            activity                respondents       respondent         Hours per response           hours
----------------------------------------------------------------------------------------------------------------
Conference Evaluation...........              364                1  15 minutes.................               91
----------------------------------------------------------------------------------------------------------------


    Dated: June 17, 2020.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2020-13575 Filed 6-23-20; 8:45 am]
BILLING CODE 4154-01-P
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