Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Maternal and Child Health Bureau Performance Measures for Discretionary Grant Information System (DGIS), OMB No. 0915-0298-Revision, 23796-23797 [2019-10807]

Download as PDF 23796 Federal Register / Vol. 84, No. 100 / Thursday, May 23, 2019 / Notices opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under Application No. Drug Applicant ANDA 040524 ...................... ANDA 070857 ...................... Promethazine Hydrochloride (HCl) Injection USP, 25 milligrams (mg)/milliliter (mL) and 50 mg/mL. Trazodone HCl Tablets USP, 50 mg .............................. ANDA 070987 ...................... Diazepam Tablets USP, 2 mg ........................................ ANDA 070996 ...................... ANDA 071717 ...................... Diazepam Tablets USP, 5 mg ........................................ Flurazepam HCl Capsules USP, 15 mg and 30 mg ...... ANDA 071751 ...................... ANDA 071752 ...................... ANDA 077190 ...................... Methyldopa Tablets USP, 125 mg .................................. Methyldopa Tablets USP, 250 mg .................................. Milrinone Lactate Injection, EQ 1 mg base/mL .............. ANDA 077703 ...................... Pamidronate Disodium for Injection USP, 30 mg/vial and 90 mg/vial. ANDA ANDA ANDA ANDA ANDA 083930 ...................... ANDA 084676 ...................... ANDA 085088 ...................... Prednisone Tablets USP, 5 mg ...................................... Chlorpheniramine Maleate Tablets USP, 4 mg .............. Niacin Tablets USP, 500 mg .......................................... Kloromin (chlorpheniramine maleate) Tablets USP, 4 mg. Dextroamphetamine Sulfate Tablets USP, 10 mg .......... Secobarbital Sodium Capsules USP, 100 mg ................ Hydralazine HCl Tablets USP, 50 mg ............................ Bedford Laboratories, 300 Northfield Rd., Bedford, OH 44146. Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. Halsey Drug Co., Inc., 1827 Pacific St., Brooklyn, NY 11233. Do. Aurolife Pharma, LLC, 279 Princeton Hightstown Rd., East Windsor, NJ 08520. Halsey Drug Co., Inc. Do. Gland Pharma, Ltd., c/o INC Research, LLC, 4800 Falls of Neuse Rd., Suite 600, Raleigh, NC 27609. Sun Pharma Global FZE, c/o Sun Pharmaceutical Industries, Inc., 270 Prospect Plains Rd., Cranbury, NJ 08512. Halsey Drug Co., Inc. Aurolife Pharma, LLC. Halsey Drug Co., Inc. Do. ANDA 085219 ...................... ANDA 085923 ...................... ANDA 087279 ...................... Hydrochlorothiazide Tablets, 50 mg ............................... Amitriptyline HCl Tablets USP, 10 mg ............................ Butalbital, Aspirin, and Caffeine Tablets ......................... ANDA 088116 ...................... Myfed (pseudoephedrine HCl and triprolidine HCl) Syrup, 30 mg/5 mL and 1.25 mg/5 mL. Chlorpropamide Tablets USP, 100 mg ........................... Hydralazine HCl Tablets USP, 25 mg ............................ Hydralazine HCl Tablets USP, 100 mg .......................... Levofloxacin Tablets, 250 mg, 500 mg, and 750 mg ..... ANDA ANDA ANDA ANDA khammond on DSKBBV9HB2PROD with NOTICES § 314.150(c) is without prejudice to refiling. 080300 080961 083453 083629 088725 089130 089178 201484 ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of June 24, 2019. Approval of each entire application is withdrawn, including any strengths or products inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on June 24, 2019, may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. Dated: May 20, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–10809 Filed 5–22–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 16:40 May 22, 2019 Jkt 247001 Do. Do. Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN 55369. Aurolife Pharma, LLC. Halsey Drug Co., Inc. Sandoz, Inc., 227–15 North Conduit Ave., Laurelton, NY 11413. USL Pharma, LLC, 301 South Cherokee St., Denver, CO 80223. Aurolife Pharma, LLC. Halsey Drug Co., Inc. Do. Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Maternal and Child Health Bureau Performance Measures for Discretionary Grant Information System (DGIS), OMB No. 0915–0298— Revision Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. Comments on this ICR should be received no later than June 24, 2019. DATES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to OIRA_ submission@omb.eop.gov or by fax to 202–395–5806. ADDRESSES: To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer, at paperwork@hrsa.gov or call (301) 443– 1984. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Information Collection Request Title: Maternal and Child Health Bureau Performance Measures for Discretionary Grant Information System (DGIS), OMB No. 0915–0298—Revision. E:\FR\FM\23MYN1.SGM 23MYN1 23797 Federal Register / Vol. 84, No. 100 / Thursday, May 23, 2019 / Notices Abstract: This Information Collection Request is for continued approval of performance measures for HRSA’s Maternal and Child Health Bureau (MCHB) discretionary grants, specifically, the continued use of reporting requirements for grant programs administered by MCHB in accordance with the ‘‘Government Performance and Results Act of 1993’’ (Pub. L. 103–62). This Act requires the preparation of an annual performance plan covering each program activity set forth in the agency’s budget, which includes establishment of measurable goals that may be reported in an annual financial statement to support the linkage of funding decisions with performance. Performance measures for MCHB discretionary grants were initially approved in 2003, and the latest approval was obtained in 2016 for significant revisions. OMB approval is currently being sought to continue the use of performance measures with minor revisions. Most of these measures are specific to certain types of programs and are not required of all grantees. The measures are categorized by domains (Adolescent Health, Capacity Building, Child Health, Children with Special Health Care Needs, Lifecourse/ Crosscutting, Maternal/Women Health, and Perinatal/Infant Health). In addition, there are some programspecific measures. Grant programs are assigned domains based on their activities. HRSA is proposing to make changes to the DGIS to more closely align data collection forms with current program activities. These revisions will facilitate more accurate reporting of descriptive information related to Longterm Trainees in Maternal and Child Health, as well as activities related to Technical Assistance for programs. Proposed changes include the following: • Trainee Information (Long-term Trainees Only) form: Æ Changes will incorporate options and titles that were omitted from the final submission of the previous OMB package, providing clarification for the reporting of specific descriptive information about Long-term Trainees on the form. Æ Changes will list the following options for ‘‘Type’’: ‘‘Non-Degree Seeking,’’ ‘‘Undergraduate,’’ ‘‘Masters,’’ ‘‘Doctoral,’’ Post-doctoral,’’ ‘‘Other.’’ Æ Changes will list the title ‘‘Student Status’’ next to the options for ‘‘Parttime student’’ and ‘‘Full-time student.’’ • Technical Assistance/Collaboration form: Æ Add a field asking for the ‘‘Total number of TA recipients.’’ This change will allow for better alignment with this data that was previously collected by program, but omitted due to a DGIS paper form error. Æ Add an ‘‘Other’’ category to List B under ‘‘Topic of Technical Assistance/ Collaboration.’’ This change would facilitate more accurate data reporting by providing programs an additional category to choose from if their current Technical Assistance activities do not closely align with the existing categories in List B. A 60-day Federal Register Notice was published in the Federal Register on November 13, 2018 Vol. 83, No. 219, pp. 56353–54). No public comments were received. Need and Proposed Use of the Information: The performance data collected through the DGIS serves several purposes, including grantee monitoring, program planning, performance reporting, and the ability to demonstrate alignment between MCHB discretionary programs and the Title V MCH Services Block Grant program. This revision will facilitate more accurate reporting of descriptive information related to Long-term Trainees in Maternal and Child Health, as well as activities related to Technical Assistance for programs. Likely Respondents: The grantees for Maternal and Child Health Bureau Discretionary Grant Programs. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. 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. The total annual burden hours estimated for this ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS Number of respondents Form name Average burden per response (in hours) Total responses Total burden hours Grant Report ........................................................................ 700 1 700 36 25,200 Total .............................................................................. 700 ........................ 700 ........................ 25,200 Amy P. McNulty, Acting Director, Division of the Executive Secretariat. Department of Health and Human Services. ACTION: [FR Doc. 2019–10807 Filed 5–22–19; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Request for Nominations to the Advisory Council on Alzheimer’s Research, Care, and Services Office of the Assistant Secretary for Planning and Evaluation, AGENCY: VerDate Sep<11>2014 16:40 May 22, 2019 Notice. The Secretary of HHS established the Advisory Council to provide advice and consultation to the Secretary on how to prevent or reduce the burden of Alzheimer’s disease and related dementias on people with the disease and their caregivers. The Secretary signed the charter establishing the Advisory Council on May 23, 2011. HHS is soliciting nominations for five (5) new non-Federal members of the SUMMARY: BILLING CODE 4165–15–P khammond on DSKBBV9HB2PROD with NOTICES Number of responses per respondent Jkt 247001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 Advisory Council to replace the five members whose terms will end September 30, 2019. Nominations should include the nominee’s contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume. DATES: Submit nominations by email or USPS mail before COB on June 28, 2019. ADDRESSES: Nominations should be sent by email to Helen Lamont at helen. lamont@hhs.gov; or sent by USPS mail to: Helen Lamont, Office of the Assistant Secretary for Planning and Evaluation, Room 424E, Humphrey Building, 200 E:\FR\FM\23MYN1.SGM 23MYN1

Agencies

[Federal Register Volume 84, Number 100 (Thursday, May 23, 2019)]
[Notices]
[Pages 23796-23797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10807]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission to OMB for 
Review and Approval; Public Comment Request; Information Collection 
Request Title: Maternal and Child Health Bureau Performance Measures 
for Discretionary Grant Information System (DGIS), OMB No. 0915-0298--
Revision

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice.

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

SUMMARY: In compliance with of the Paperwork Reduction Act of 1995, 
HRSA has submitted an Information Collection Request (ICR) to the 
Office of Management and Budget (OMB) for review and approval. Comments 
submitted during the first public review of this ICR will be provided 
to OMB. OMB will accept further comments from the public during the 
review and approval period.

DATES: Comments on this ICR should be received no later than June 24, 
2019.

ADDRESSES: Submit your comments, including the Information Collection 
Request Title, to the desk officer for HRSA, either by email to 
[email protected] or by fax to 202-395-5806.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email Lisa Wright-Solomon, the 
HRSA Information Collection Clearance Officer, at [email protected] or 
call (301) 443-1984.

SUPPLEMENTARY INFORMATION: 
    Information Collection Request Title: Maternal and Child Health 
Bureau Performance Measures for Discretionary Grant Information System 
(DGIS), OMB No. 0915-0298--Revision.

[[Page 23797]]

    Abstract: This Information Collection Request is for continued 
approval of performance measures for HRSA's Maternal and Child Health 
Bureau (MCHB) discretionary grants, specifically, the continued use of 
reporting requirements for grant programs administered by MCHB in 
accordance with the ``Government Performance and Results Act of 1993'' 
(Pub. L. 103-62). This Act requires the preparation of an annual 
performance plan covering each program activity set forth in the 
agency's budget, which includes establishment of measurable goals that 
may be reported in an annual financial statement to support the linkage 
of funding decisions with performance. Performance measures for MCHB 
discretionary grants were initially approved in 2003, and the latest 
approval was obtained in 2016 for significant revisions. OMB approval 
is currently being sought to continue the use of performance measures 
with minor revisions. Most of these measures are specific to certain 
types of programs and are not required of all grantees. The measures 
are categorized by domains (Adolescent Health, Capacity Building, Child 
Health, Children with Special Health Care Needs, Lifecourse/
Crosscutting, Maternal/Women Health, and Perinatal/Infant Health). In 
addition, there are some program-specific measures. Grant programs are 
assigned domains based on their activities. HRSA is proposing to make 
changes to the DGIS to more closely align data collection forms with 
current program activities. These revisions will facilitate more 
accurate reporting of descriptive information related to Long-term 
Trainees in Maternal and Child Health, as well as activities related to 
Technical Assistance for programs. Proposed changes include the 
following:
     Trainee Information (Long-term Trainees Only) form:
    [cir] Changes will incorporate options and titles that were omitted 
from the final submission of the previous OMB package, providing 
clarification for the reporting of specific descriptive information 
about Long-term Trainees on the form.
    [cir] Changes will list the following options for ``Type'': ``Non-
Degree Seeking,'' ``Undergraduate,'' ``Masters,'' ``Doctoral,'' Post-
doctoral,'' ``Other.''
    [cir] Changes will list the title ``Student Status'' next to the 
options for ``Part-time student'' and ``Full-time student.''
     Technical Assistance/Collaboration form:
    [cir] Add a field asking for the ``Total number of TA recipients.'' 
This change will allow for better alignment with this data that was 
previously collected by program, but omitted due to a DGIS paper form 
error.
    [cir] Add an ``Other'' category to List B under ``Topic of 
Technical Assistance/Collaboration.'' This change would facilitate more 
accurate data reporting by providing programs an additional category to 
choose from if their current Technical Assistance activities do not 
closely align with the existing categories in List B.
    A 60-day Federal Register Notice was published in the Federal 
Register on November 13, 2018 Vol. 83, No. 219, pp. 56353-54). No 
public comments were received.
    Need and Proposed Use of the Information: The performance data 
collected through the DGIS serves several purposes, including grantee 
monitoring, program planning, performance reporting, and the ability to 
demonstrate alignment between MCHB discretionary programs and the Title 
V MCH Services Block Grant program. This revision will facilitate more 
accurate reporting of descriptive information related to Long-term 
Trainees in Maternal and Child Health, as well as activities related to 
Technical Assistance for programs.
    Likely Respondents: The grantees for Maternal and Child Health 
Bureau Discretionary Grant Programs.
    Burden Statement: Burden in this context means the time expended by 
persons to generate, maintain, retain, disclose or provide the 
information requested. 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. The total annual burden hours estimated for 
this ICR are summarized in the table below.

                                    Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Grant Report....................             700               1             700              36          25,200
                                 -------------------------------------------------------------------------------
    Total.......................             700  ..............             700  ..............          25,200
----------------------------------------------------------------------------------------------------------------


Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2019-10807 Filed 5-22-19; 8:45 am]
 BILLING CODE 4165-15-P
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