81 FR 61219 - Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families Federal Register Volume 81, Issue 172 (September 6, 2016)
Administration for Children and Families
Federal Register Volume 81, Issue 172 (September 6, 2016)
| Page Range | 61219-61220 | |
| FR Document | 2016-21250 |
[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)] [Notices] [Pages 61219-61220] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-21250] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Ethnic Community Self-Help Program Data Indicators. OMB No.: 0970-NEW. Description: The ACF Office of Refugee Resettlement proposes to collect information from Ethnic Community-Based Organizations (ECBOs) awarded federal funds under HHS-2016-ACF-ORR-1129. The information, collected through a questionnaire, is expected to provide information on Program objectives semi-annually in order for program staff to gauge the Program's progress for reporting and evaluation purposes. Respondents: ECBOs awarded under HHS-2016-ACF-ORR-1129. Annual Burden Estimates ---------------------------------------------------------------------------------------------------------------- Number of Average burden Instrument Number of responses per hours per Total burden respondents respondent response hours ---------------------------------------------------------------------------------------------------------------- ECSH Data Indicators........................ 10 2 1 20 ---------------------------------------------------------------------------------------------------------------- Estimated Total Annual Burden Hours: 20. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected]. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected]. Attn: [[Page 61220]] Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2016-21250 Filed 9-2-16; 8:45 am] BILLING CODE 4184-01-P
![Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices 61219
to understand current provider obtain a study target of 600 respondents. regarding maternal opioid use, their
knowledge, attitudes, and practices The initial invitation will be distributed screening and referral practices for
regarding maternal opioid use. by email with instructions on pregnant or postpartum patients,
CDC, in collaboration with the completing a web-based version of the barriers to screening and treating
American College of Obstetricians and questionnaire. Three to four months pregnant and postpartum patients for
Gynecologists (ACOG), plans to conduct after the initial invitation, a paper opioid use, and resources that are
a survey to address this gap in version of the questionnaire will be needed to improve treatment and
knowledge. Survey respondents will be distributed to individuals who have not referral. No information will be
ACOG Fellows and Junior Fellows who completed the online version. The collected about individual patients.
have a current medical license and are estimated number of respondents for the
Survey administration and data
in medical practice focused on women’s full web-based or paper questionnaire is
health. ACOG is separated into 11 management will be conducted by
420 and the estimated burden per
districts, one of which represents OB/ response is 15 minutes. Approximately ACOG, and participation is voluntary.
GYN members who are in the U.S. 6 weeks after the second recruitment De-identified response data will be
military. The remaining 10 ACOG attempt, ACOG will distribute a short shared with CDC for analysis. Findings
districts correspond to geographic version of the questionnaire to any non- will be used to create recommendations
regions that encompass the entire responders. The estimated number of for educational programs and patient
United States and Canada. Survey responses for the short version of the care. The total estimated annualized
invitations will be sent to a quasi- questionnaire is 180 and the estimated burden hours are 120. There are no costs
random sample of ACOG members in burden per response is 5 minutes. An to participants other than their time.
each district. overall 40% response rate is expected.
CDC and ACOG estimate that 1,500 The survey will collect information
individuals will be contacted in order to about provider attitudes and beliefs
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
OB/GYNs caring for pregnant Practice Patterns related to Opioid Use during Pregnancy 420 1 15/60
women. and Lactation—Full survey.
Practice Patterns related to Opioid Use during Pregnancy 180 1 5/60
and Lactation—Short introduction and survey.
Leroy A. Richardson, DEPARTMENT OF HEALTH AND collect information from Ethnic
Chief, Information Collection Review Office, HUMAN SERVICES Community-Based Organizations
Office of Scientific Integrity, Office of the (ECBOs) awarded federal funds under
Associate Director for Science, Office of the Administration for Children and HHS–2016–ACF–ORR–1129. The
Director, Centers for Disease Control and Families information, collected through a
Prevention. questionnaire, is expected to provide
[FR Doc. 2016–21273 Filed 9–2–16; 8:45 am] Submission for OMB Review;
Comment Request information on Program objectives semi-
BILLING CODE 4163–18–P annually in order for program staff to
Title: Ethnic Community Self-Help gauge the Program’s progress for
Program Data Indicators. reporting and evaluation purposes.
OMB No.: 0970–NEW.
Description: The ACF Office of Respondents: ECBOs awarded under
Refugee Resettlement proposes to HHS–2016–ACF–ORR–1129.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
ECSH Data Indicators ..................................................................................... 10 2 1 20
Estimated Total Annual Burden of the information collection. Email comments and recommendations for the
Hours: 20. address: infocollection@acf.hhs.gov. proposed information collection should
Additional Information: Copies of the OMB Comment: OMB is required to be sent directly to the following: Office
mstockstill on DSK3G9T082PROD with NOTICES
proposed collection may be obtained by make a decision concerning the of Management and Budget, Paperwork
writing to the Administration for collection of information between 30 Reduction Project, Email: OIRA_
Children and Families, Office of and 60 days after publication of this SUBMISSION@OMB.EOP.GOV. Attn:
Planning, Research and Evaluation, 330 document in the Federal Register.
C Street SW., Washington, DC 20201. Therefore, a comment is best assured of
Attention Reports Clearance Officer. All having its full effect if OMB receives it
requests should be identified by the title within 30 days of publication. Written
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![61220 Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices
Desk Officer for the Administration for refer to the products as long as they FDA publishes this list as part of the
Children and Families. meet relevant legal and regulatory ‘‘Approved Drug Products With
requirements. Therapeutic Equivalence Evaluations,’’
Robert Sargis,
FOR FURTHER INFORMATION CONTACT:
which is generally known as the
Reports Clearance Officer.
Stacy Kane, Center for Drug Evaluation ‘‘Orange Book.’’ Under FDA regulations,
[FR Doc. 2016–21250 Filed 9–2–16; 8:45 am]
and Research, Food and Drug a drug is removed from the list if the
BILLING CODE 4184–01–P
Administration, 10903 New Hampshire Agency withdraws or suspends
Ave., Bldg. 51, Rm. 6207, Silver Spring, approval of the drug’s NDA or ANDA
MD 20993–0002, 301–796–8363, for reasons of safety or effectiveness, or
DEPARTMENT OF HEALTH AND
Stacy.Kane@fda.hhs.gov. if FDA determines that the listed drug
HUMAN SERVICES
was withdrawn from sale for reasons of
SUPPLEMENTARY INFORMATION: In 1984,
Food and Drug Administration safety or effectiveness (21 CFR 314.162).
Congress enacted the Drug Price
[Docket No. FDA–2016–N–2526] Competition and Patent Term Under § 314.161(a) (21 CFR
Restoration Act of 1984 (Pub. L. 98–417) 314.161(a)), the Agency must determine
Determination That AQUAMEPHYTON (the 1984 amendments), which whether a listed drug was withdrawn
(Phytonadione) Injectable and Other authorized the approval of duplicate from sale for reasons of safety or
Drug Products Were Not Withdrawn versions of drug products approved effectiveness: (1) Before an ANDA that
From Sale for Reasons of Safety or under an ANDA procedure. ANDA refers to that listed drug may be
Effectiveness applicants must, with certain approved, (2) whenever a listed drug is
exceptions, show that the drug for voluntarily withdrawn from sale and
AGENCY: Food and Drug Administration, ANDAs that refer to the listed drug have
HHS. which they are seeking approval
contains the same active ingredient in been approved, and (3) when a person
ACTION: Notice. petitions for such a determination under
the same strength and dosage form as
SUMMARY: The Food and Drug the ‘‘listed drug,’’ which is a version of 21 CFR 10.25(a) and 10.30. Section
Administration (FDA or Agency) has the drug that was previously approved. 314.161(d) provides that if FDA
determined that the drug products listed ANDA applicants do not have to repeat determines that a listed drug was
in this document were not withdrawn the extensive clinical testing otherwise withdrawn from sale for safety or
from sale for reasons of safety or necessary to gain approval of a new effectiveness reasons, the Agency will
effectiveness. This determination means drug application (NDA). initiate proceedings that could result in
that FDA will not begin procedures to The 1984 amendments include what the withdrawal of approval of the
withdraw approval of abbreviated new is now section 505(j)(7) of the Federal ANDAs that refer to the listed drug.
drug applications (ANDAs) that refer to Food, Drug, and Cosmetic Act (21 U.S.C. FDA has become aware that the drug
these drug products, and it will allow 355(j)(7)), which requires FDA to products listed in the table in this
FDA to continue to approve ANDAs that publish a list of all approved drugs. document are no longer being marketed.
Active
Application No. Drug name Strength(s) Dosage form/route Applicant
ingredient(s)
NDA 012223 ............... AQUAMEPHYTON ... Phytonadione ............ 10 milligram (mg)/mil- Injectable; Injection ... Teligent Pharma Inc.
liliter (mL); 1 mg/
0.5 mL.
NDA 016087 ............... VALIUM ..................... Diazepam .................. 5 mg/mL .................... Injectable; Injection ... Roche.
NDA 017090 ............... TOFRANIL–PM ......... Imipramine Pamoate Equivalent to (EQ) 75 Capsule; Oral ............ Mallinckrodt Pharma-
mg HCl; EQ 100 ceuticals.
mg HCl; EQ 125
mg HCl; EQ 150
mg HCl.
NDA 017558 ............... ROBINUL .................. Glycopyrrolate ........... 0.2 mg/mL ................. Injectable; Injection ... Eurohealth Inter-
national Sarl.
NDA 017911 ............... CLINORIL ................. Sulindac .................... 200 mg ...................... Tablet; Oral ............... Merck.
NDA 017962 ............... PARLODEL ............... Bromocriptine EQ 5 mg base .......... Capsule; Oral ............ US Pharmaceuticals
Mesylate. Holdings I LLC.
NDA 018579 ............... FUROSEMIDE .......... Furosemide ............... 10 mg/mL .................. Injectable; Injection ... Luitpold Pharma-
ceuticals, Inc.
NDA 018687 ............... NORMODYNE .......... Labetalol Hydro- 100 mg; 200 mg; 300 Tablet; Oral ............... Schering-Plough
chloride. mg; 400 mg. Corp.
NDA 018731 ............... BUSPAR ................... Buspirone Hydro- 5 mg .......................... Tablet; Oral ............... Bristol-Myers Squibb.
chloride.
NDA 018776 ............... NORCURON ............. Vecuronium Bromide 10 mg/vial; 20 mg/vial Injectable; for Injec- Organon USA Inc.
tion.
NDA 019773 ............... VENTOLIN ................ Albuterol Sulfate ....... EQ 0.083% base ...... Solution; Inhalation ... GlaxoSmithKline.
NDA 019810 ............... PRILOSEC ................ Omeprazole .............. 10 mg; 20 mg; 40 mg Capsule, Delayed-Re- AstraZeneca Pharma-
lease Pellets; Oral. ceuticals LP.
mstockstill on DSK3G9T082PROD with NOTICES
NDA 020059 ............... ADENOSCAN ........... Adenosine ................. 60 mg/20 mL (3 mg/ Solution; I.V. Infusion Astellas Pharma US,
mL); 90 mg/30 mL Inc.
(3 mg/mL).
NDA 020799 ............... FLOXIN OTIC ........... Ofloxacin ................... 0.3% .......................... Solution/Drops; Otic .. Daiichi-Sankyo.
NDA 021045 ............... PLAN B ..................... Levonorgestrel .......... 0.75 mg ..................... Tablet; Oral ............... Teva Branded Pharm.
NDA 021214 ............... RESCULA ................. Unoprostone Iso- 0.15% ........................ Solution/Drops; Oph- Sucampo Pharma-
propyl. thalmic. ceuticals, Inc.
NDA 050459 ............... AMOXIL .................... Amoxicillin ................. 250 mg; 500 mg ....... Capsule; Oral ............ GlaxoSmithKline.
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Document Created: 2018-02-09 12:04:25
Document Modified: 2018-02-09 12:04:25
| 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 | 81 FR 61219 |
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