Submission for OMB Review; Comment Request, 61219-61220 [2016-21250]
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61219
Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices
to understand current provider
knowledge, attitudes, and practices
regarding maternal opioid use.
CDC, in collaboration with the
American College of Obstetricians and
Gynecologists (ACOG), plans to conduct
a survey to address this gap in
knowledge. Survey respondents will be
ACOG Fellows and Junior Fellows who
have a current medical license and are
in medical practice focused on women’s
health. ACOG is separated into 11
districts, one of which represents OB/
GYN members who are in the U.S.
military. The remaining 10 ACOG
districts correspond to geographic
regions that encompass the entire
United States and Canada. Survey
invitations will be sent to a quasirandom sample of ACOG members in
each district.
CDC and ACOG estimate that 1,500
individuals will be contacted in order to
obtain a study target of 600 respondents.
The initial invitation will be distributed
by email with instructions on
completing a web-based version of the
questionnaire. Three to four months
after the initial invitation, a paper
version of the questionnaire will be
distributed to individuals who have not
completed the online version. The
estimated number of respondents for the
full web-based or paper questionnaire is
420 and the estimated burden per
response is 15 minutes. Approximately
6 weeks after the second recruitment
attempt, ACOG will distribute a short
version of the questionnaire to any nonresponders. The estimated number of
responses for the short version of the
questionnaire is 180 and the estimated
burden per response is 5 minutes. An
overall 40% response rate is expected.
The survey will collect information
about provider attitudes and beliefs
regarding maternal opioid use, their
screening and referral practices for
pregnant or postpartum patients,
barriers to screening and treating
pregnant and postpartum patients for
opioid use, and resources that are
needed to improve treatment and
referral. No information will be
collected about individual patients.
Survey administration and data
management will be conducted by
ACOG, and participation is voluntary.
De-identified response data will be
shared with CDC for analysis. Findings
will be used to create recommendations
for educational programs and patient
care. The total estimated annualized
burden hours are 120. There are no costs
to participants other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
OB/GYNs caring for pregnant
women.
Practice Patterns related to Opioid Use during Pregnancy
and Lactation—Full survey.
Practice Patterns related to Opioid Use during Pregnancy
and Lactation—Short introduction and survey.
Leroy A. Richardson,
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. 2016–21273 Filed 9–2–16; 8:45 am]
BILLING CODE 4163–18–P
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
Number of
responses per
respondent
Average
burden per
response
(in hours)
420
1
15/60
180
1
5/60
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 semiannually 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
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ECSH Data Indicators .....................................................................................
mstockstill on DSK3G9T082PROD with NOTICES
Instrument
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
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of the information collection. Email
address: infocollection@acf.hhs.gov.
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
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comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV. Attn:
E:\FR\FM\06SEN1.SGM
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61220
Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2016–21250 Filed 9–2–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2526]
Determination That AQUAMEPHYTON
(Phytonadione) Injectable and Other
Drug Products Were Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
refer to the products as long as they
meet relevant legal and regulatory
requirements.
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that the drug products listed
in this document were 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
these drug products, and it will allow
FDA to continue to approve ANDAs that
SUMMARY:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6207, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@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 approved
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 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 generally known as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is 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).
Under § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) Before an ANDA that
refers to that listed drug may be
approved, (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved, and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for safety or
effectiveness reasons, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA has become aware that the drug
products listed in the table in this
document are no longer being marketed.
Drug name
Active
ingredient(s)
Strength(s)
Dosage form/route
NDA 012223 ...............
AQUAMEPHYTON ...
Phytonadione ............
Teligent Pharma Inc.
VALIUM .....................
TOFRANIL–PM .........
Diazepam ..................
Imipramine Pamoate
Injectable; Injection ...
Capsule; Oral ............
Roche.
Mallinckrodt Pharmaceuticals.
NDA 017558 ...............
ROBINUL ..................
Glycopyrrolate ...........
10 milligram (mg)/milliliter (mL); 1 mg/
0.5 mL.
5 mg/mL ....................
Equivalent to (EQ) 75
mg HCl; EQ 100
mg HCl; EQ 125
mg HCl; EQ 150
mg HCl.
0.2 mg/mL .................
Injectable; Injection ...
NDA 016087 ...............
NDA 017090 ...............
Injectable; Injection ...
NDA 017911 ...............
NDA 017962 ...............
CLINORIL .................
PARLODEL ...............
Tablet; Oral ...............
Capsule; Oral ............
FUROSEMIDE ..........
Sulindac ....................
Bromocriptine
Mesylate.
Furosemide ...............
200 mg ......................
EQ 5 mg base ..........
NDA 018579 ...............
10 mg/mL ..................
Injectable; Injection ...
NDA 018687 ...............
NORMODYNE ..........
BUSPAR ...................
100 mg; 200 mg; 300
mg; 400 mg.
5 mg ..........................
Eurohealth International Sarl.
Merck.
US Pharmaceuticals
Holdings I LLC.
Luitpold Pharmaceuticals, Inc.
Schering-Plough
Corp.
Bristol-Myers Squibb.
NDA 018776 ...............
NORCURON .............
Labetalol Hydrochloride.
Buspirone Hydrochloride.
Vecuronium Bromide
Tablet; Oral ...............
NDA 018731 ...............
10 mg/vial; 20 mg/vial
NDA 019773 ...............
NDA 019810 ...............
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Application No.
VENTOLIN ................
PRILOSEC ................
Albuterol Sulfate .......
Omeprazole ..............
EQ 0.083% base ......
10 mg; 20 mg; 40 mg
NDA 020059 ...............
ADENOSCAN ...........
Adenosine .................
NDA 020799 ...............
NDA 021045 ...............
NDA 021214 ...............
FLOXIN OTIC ...........
PLAN B .....................
RESCULA .................
NDA 050459 ...............
AMOXIL ....................
Ofloxacin ...................
Levonorgestrel ..........
Unoprostone Isopropyl.
Amoxicillin .................
60 mg/20 mL (3 mg/
mL); 90 mg/30 mL
(3 mg/mL).
0.3% ..........................
0.75 mg .....................
0.15% ........................
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250 mg; 500 mg .......
Sfmt 4703
Tablet; Oral ...............
Injectable; for Injection.
Solution; Inhalation ...
Capsule, Delayed-Release Pellets; Oral.
Solution; I.V. Infusion
Solution/Drops; Otic ..
Tablet; Oral ...............
Solution/Drops; Ophthalmic.
Capsule; Oral ............
E:\FR\FM\06SEN1.SGM
06SEN1
Applicant
Organon USA Inc.
GlaxoSmithKline.
AstraZeneca Pharmaceuticals LP.
Astellas Pharma US,
Inc.
Daiichi-Sankyo.
Teva Branded Pharm.
Sucampo Pharmaceuticals, Inc.
GlaxoSmithKline.
Agencies
[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)]
[Notices]
[Pages 61219-61220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: infocollection@acf.hhs.gov.
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:
OIRA_SUBMISSION@OMB.EOP.GOV. 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