83 FR 8090 - Meeting of the Secretary's Advisory Committee on Human Research Protections

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 37 (February 23, 2018)

Page Range		8090-8091
FR Document		2018-03768

Pursuant to Section 10(a) of the Federal Advisory Committee Act, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP website at: http://www.dhhs.gov/ ohrp/sachrp-committee/meetings/index.html.

Federal Register, Volume 83 Issue 37 (Friday, February 23, 2018)

[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)]
[Notices]
[Pages 8090-8091]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-03768]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Secretary's Advisory Committee on Human Research 
Protections

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services.

ACTION: Notice.

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

SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee 
Act, notice is hereby given that the Secretary's Advisory Committee on

[[Page 8091]]

Human Research Protections (SACHRP) will hold a meeting that will be 
open to the public. Information about SACHRP and the full meeting 
agenda will be posted on the SACHRP website at: http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html.

DATES: The meeting will be held on Tuesday, March 13, 2018, from 8:30 
a.m. until 5:00 p.m., and Wednesday, March 14, 2018, from 8:30 a.m. 
until 4:00 p.m.

ADDRESSES: Fishers Lane Conference Center, Terrace Level, 5635 Fishers 
Lane, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT:  Julia Gorey, J.D., Executive 
Director, SACHRP; U.S. Department of Health and Human Services, 1101 
Wootton Parkway, Suite 200, Rockville, Maryland 20852; telephone: 240-
453-8141; fax: 240-453-6909; email address: SACHRP@hhs.gov.

SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a, 
Section 222 of the Public Health Service Act, as amended, SACHRP was 
established to provide expert advice and recommendations to the 
Secretary of Health and Human Services (HHS), through the Assistant 
Secretary for Health, on issues and topics pertaining to or associated 
with the protection of human research subjects.
    The Subpart A Subcommittee (SAS) was established by SACHRP in 
October 2006 and is charged with developing recommendations for 
consideration by SACHRP regarding the application of subpart A of 45 
CFR part 46 in the current research environment.
    The Subcommittee on Harmonization (SOH) was established by SACHRP 
at its July 2009 meeting and charged with identifying and prioritizing 
areas in which regulations and/or guidelines for human subjects 
research adopted by various agencies or offices within HHS would 
benefit from harmonization, consistency, clarity, simplification and/or 
coordination.
    The SACHRP meeting will open to the public at 8:30 a.m., on 
Tuesday, March 13, 2018, followed by opening remarks from Dr. Jerry 
Menikoff, Director of the Office for Human Research Protections and Dr. 
Stephen Rosenfeld, SACHRP Chair.
    The SAS and SOH subcommittees will present their recommendations 
regarding the description of ``key information,'' as required by the 
revised Common Rule's Sec.  46.116(a)(5)(i). This will be followed by a 
discussion of SOH recommendations on the research use of repositories 
and registries under various consent models, under both the current and 
the revised Common Rule. The Tuesday, March 13, meeting will adjourn at 
approximately 5:00 p.m.
    The Wednesday, March 14, meeting will begin at 8:30 a.m. The SOH 
will present and discuss recommendations on the European Union's 
General Data Protection Regulation and its impact on U.S. human 
subjects research. Modifications to the previous day's work will be 
discussed and finalized. The meeting will adjourn at approximately 4:00 
p.m.
    Time for public comment sessions will be allotted both days. On-
site registration is required for participation in the live public 
comment session. Note that public comment must be relevant to issues 
currently being addressed by the SACHRP. Individuals submitting written 
statements as public comment should email or fax their comments to 
SACHRP at SACHRP@hhs.gov at least five business days prior to the 
meeting.
    Public attendance at the meeting is limited to space available. 
Individuals who plan to attend and need special assistance, such as 
sign language interpretation or other reasonable accommodations, should 
notify the designated SACHRP point of contact at the address/phone 
number listed above at least one week prior to the meeting.

    Dated: February 16, 2018.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2018-03768 Filed 2-22-18; 8:45 am]
 BILLING CODE 4150-36-P

8090 Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices

new drug applications (ANDAs) from FOR FURTHER INFORMATION CONTACT: have requested that FDA withdraw
multiple applicants. The holders of the Trang Tran, Center for Drug Evaluation approval of the applications under the
applications notified the Agency in and Research, Food and Drug process in § 314.150(c) (21 CFR
writing that the drug products were no Administration, 10903 New Hampshire 314.150(c)). The applicants have also,
longer marketed and requested that the Ave., Bldg. 75, Rm. 1671, Silver Spring, by their requests, waived their
approval of the applications be MD 20993–0002, 240–402–7945, opportunity for a hearing. Withdrawal
withdrawn. Trang.Tran@fda.hhs.gov. of approval of an application or
SUPPLEMENTARY INFORMATION: The abbreviated application under
DATES:Approval is withdrawn as of holders of the applications listed in the § 314.150(c) is without prejudice to
March 26, 2018. table have informed FDA that these drug refiling.
products are no longer marketed and

Application No. Drug Applicant

ANDA 040398 .... MiCort-HC (hydrocortisone acetate) Cream USP, 2% ............ Sebela Ireland, Ltd., c/o Sebela Pharmaceuticals, Inc., 645
Hembree Parkway, Suite 1, Roswell, GA 30076.
ANDA 071893 .... Acetohexamide Tablets, 250 milligrams (mg) ......................... Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 071894 .... Acetohexamide Tablets, 500 mg ............................................. Do.
ANDA 073143 .... Cyclobenzaprine Hydrochloride (HCl) Tablets USP, 10 mg .... Do.
ANDA 074576 .... Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 mg Do.
ANDA 076607 .... Quinapril Tablets USP, Equivalent to (EQ) 5 mg base, EQ 10 Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical
mg base, EQ 20 mg base, and EQ 40 mg base. Industries, Inc., 2 Independence Way, Princeton, NJ
08540.
ANDA 076786 .... Donepezil HCl Tablets USP, 5 mg and 10 mg ........................ Do.
ANDA 077483 .... Benazepril HCl and Hydrochlorothiazide Tablets, 5 mg/6.25 Do.
mg, 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg.
ANDA 078502 .... Eliphos (calcium acetate) Tablets USP, 667 mg ..................... Cypress Pharmaceutical, Inc., 10 North Park Pl., Suite 201,
Morristown, NJ 07960.
ANDA 081019 .... Chlorzoxazone Tablets USP, 500 mg ..................................... Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc.
ANDA 083821 .... Brompheniramine Maleate Injection, 10 mg/milliliter (mL) ...... Do.
ANDA 084408 .... Bethanechol Chloride Tablets USP, 10 mg ............................. Do.
ANDA 084441 .... Bethanechol Chloride Tablets USP, 25 mg ............................. Do.
ANDA 085283 .... Theolair (theophylline) Tablets, 125 mg and 250 mg .............. 3M Drug Delivery Systems, 3M Center, Bldg. 275–3E–02,
2510 Conway Ave., St. Paul, MN 55144.
ANDA 085738 .... Betamethasone Sodium Phosphate Injection, EQ 3 mg base/ Watson Laboratories, Inc., Subsidiary of Teva Pharma-
mL. ceuticals USA, Inc.
ANDA 087444 .... Bethanechol Chloride Tablets USP, 50 mg ............................. Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc.
ANDA 087792 .... Fluorouracil Injection USP, 50 mg/mL ..................................... Spectrum Pharmaceuticals, Inc., 157 Technology Dr., Irvine,
CA 92618.
ANDA 087978 .... Diphenhydramine HCl Capsules, 50 mg ................................. LNK International, Inc., 145 Ricefield Ln., Hauppauge, NY
11788.
ANDA 090417 .... Carbinoxamine Maleate Tablets USP, 4 mg ........................... Cypress Pharmaceutical, Inc.
ANDA 090418 .... Carbinoxamine Maleate Oral Solution, 4 mg/5 mL ................. Do.
ANDA 090468 .... Zyfrel (acetaminophen and hydrocodone bitartrate) Oral So- Do.
lution, 325 mg/7.5 mg per 15 mL.
ANDA 091034 .... Dorzolamide HCl Ophthalmic Solution USP, EQ 2% base ..... Zambon S.p.A., c/o Camargo Pharmaceutical Services, LLC,
9825 Kenwood Rd., Suite 203, Cincinnati, OH 45242.
ANDA 200794 .... Pantoprazole Sodium Delayed-Release Tablets USP, EQ 20 Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical
mg base and EQ 40 mg base. Industries, Inc.
ANDA 206438 .... Hydrocodone Bitartrate and Chlorpheniramine Maleate Oral Tris Pharma, Inc., 2033 Route 130, Suite D, Monmouth
Solution, 5 mg/4 mg per 5 mL. Junction, NJ 08852.

Therefore, approval of the expiration dates or otherwise become DEPARTMENT OF HEALTH AND
applications listed in the table, and all violative, whichever occurs first. HUMAN SERVICES
amendments and supplements thereto, Dated: February 16, 2018.
is hereby withdrawn as of March 26, Meeting of the Secretary’s Advisory
Leslie Kux, Committee on Human Research
2018. Introduction or delivery for
Associate Commissioner for Policy. Protections
introduction into interstate commerce of
[FR Doc. 2018–03700 Filed 2–22–18; 8:45 am]
products without approved new drug AGENCY: Office of the Assistant
applications violates section 301(a) and BILLING CODE 4164–01–P
Secretary for Health, Office of the
(d) of the Federal Food, Drug, and Secretary, Department of Health and
daltland on DSKBBV9HB2PROD with NOTICES

Cosmetic Act (21 U.S.C. 331(a) and (d)). Human Services.
Drug products that are listed in the table ACTION: Notice.
that are in inventory on March 26, 2018
may continue to be dispensed until the SUMMARY: Pursuant to Section 10(a) of
inventories have been depleted or the the Federal Advisory Committee Act,
drug products have reached their notice is hereby given that the
Secretary’s Advisory Committee on

VerDate Sep<11>2014 18:52 Feb 22, 2018 Jkt 244001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1

Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Notices 8091

Human Research Protections (SACHRP) Tuesday, March 13, meeting will SUPPLEMENTARY INFORMATION:
will hold a meeting that will be open to adjourn at approximately 5:00 p.m. Colleen T. Skau, Ph.D., National
the public. Information about SACHRP The Wednesday, March 14, meeting Institutes of Health: Based on
and the full meeting agenda will be will begin at 8:30 a.m. The SOH will Respondent’s admission, an assessment
posted on the SACHRP website at: present and discuss recommendations conducted by NIH, and analysis
http://www.dhhs.gov/ohrp/sachrp- on the European Union’s General Data conducted by ORI in its oversight
committee/meetings/index.html. Protection Regulation and its impact on review, ORI found that Dr. Colleen T.
DATES: The meeting will be held on U.S. human subjects research. Skau, former postdoctoral fellow in the
Tuesday, March 13, 2018, from 8:30 Modifications to the previous day’s Cell Biology and Physiology Center,
a.m. until 5:00 p.m., and Wednesday, work will be discussed and finalized. NHLBI, NIH, engaged in research
March 14, 2018, from 8:30 a.m. until The meeting will adjourn at misconduct in research supported by
4:00 p.m. approximately 4:00 p.m. NHLBI, NIH.
ADDRESSES: Fishers Lane Conference
Time for public comment sessions ORI found that Respondent engaged
Center, Terrace Level, 5635 Fishers will be allotted both days. On-site in research misconduct by intentionally,
Lane, Rockville, Maryland 20852. registration is required for participation knowingly, or recklessly reporting
in the live public comment session. falsified and/or fabricated data and/or
FOR FURTHER INFORMATION CONTACT: Julia
Note that public comment must be falsifying and/or fabricating data in the
Gorey, J.D., Executive Director,
relevant to issues currently being following two (2) papers:
SACHRP; U.S. Department of Health
addressed by the SACHRP. Individuals • Cell 167(6):1571–1585, 2016
and Human Services, 1101 Wootton
submitting written statements as public (hereafter referred to as ‘‘Paper 1’’)
Parkway, Suite 200, Rockville,
comment should email or fax their • Proceedings of the National Academy
Maryland 20852; telephone: 240–453–
comments to SACHRP at SACHRP@ of Sciences 112(19):E2447–E2456,
8141; fax: 240–453–6909; email address:
hhs.gov at least five business days prior 2015 (hereafter referred to as ‘‘Paper
SACHRP@hhs.gov.
to the meeting. 2’’)
SUPPLEMENTARY INFORMATION: Under the Public attendance at the meeting is
authority of 42 U.S.C. 217a, Section 222 limited to space available. Individuals ORI found that Respondent engaged
of the Public Health Service Act, as who plan to attend and need special in research misconduct by intentional,
amended, SACHRP was established to assistance, such as sign language knowing, or reckless falsification and/or
provide expert advice and interpretation or other reasonable fabrication of the research record by
recommendations to the Secretary of accommodations, should notify the selectively reporting by inappropriate
Health and Human Services (HHS), designated SACHRP point of contact at inclusion/omission or alteration of data
through the Assistant Secretary for the address/phone number listed above points in ten (10) figures and falsely
Health, on issues and topics pertaining at least one week prior to the meeting. reporting the statistical significance
to or associated with the protection of based on falsified data in ten (10) figures
Dated: February 16, 2018.
human research subjects. across the two (2) papers and
The Subpart A Subcommittee (SAS) Julia G. Gorey, supplementary material. Specifically,
was established by SACHRP in October Executive Director, Secretary’s Advisory ORI found that:
2006 and is charged with developing Committee on Human Research Protections.
• In Paper 1, Respondent falsified
recommendations for consideration by [FR Doc. 2018–03768 Filed 2–22–18; 8:45 am]
and/or fabricated the research record in:
SACHRP regarding the application of BILLING CODE 4150–36–P
—Figure 3B, by selectively omitting/
subpart A of 45 CFR part 46 in the
including data points in the Rescue
current research environment.
The Subcommittee on Harmonization DEPARTMENT OF HEALTH AND condition
(SOH) was established by SACHRP at its HUMAN SERVICES —Figure 5B, by reporting a significant
July 2009 meeting and charged with difference between conditions by
identifying and prioritizing areas in Office of the Secretary performing statistical calculations
which regulations and/or guidelines for based on fabricated primary data
Findings of Research Misconduct —Figure 5C (bottom), by selectively
human subjects research adopted by
various agencies or offices within HHS AGENCY: Office of the Secretary, HHS. omitting images and conditions from
would benefit from harmonization, the analysis
ACTION: Notice.
consistency, clarity, simplification and/ —Figure 6I (bottom left), by reporting
or coordination. SUMMARY: Findings of research data from the same data set as Figure
The SACHRP meeting will open to the misconduct have been made on the part 6B (top)
public at 8:30 a.m., on Tuesday, March of Colleen T. Skau, Ph.D., former —Figure S5B, by reporting statistical
13, 2018, followed by opening remarks postdoctoral fellow in the Cell Biology significance despite performing a T
from Dr. Jerry Menikoff, Director of the and Physiology Center, National Heart, test calculation that returned an
Office for Human Research Protections Lung, and Blood Institute (NHLBI), insignificant p-value
and Dr. Stephen Rosenfeld, SACHRP National Institutes of Health (NIH). Dr. —Figure 7F, by reporting that error bars
Chair. Skau engaged in research misconduct in represented standard deviation, when
The SAS and SOH subcommittees research supported by NHLBI, NIH. The they actually represented standard
will present their recommendations administrative actions, including three error of the mean (SEM.)
regarding the description of ‘‘key (3) years of supervision, were —Figure S4D, by performing different
daltland on DSKBBV9HB2PROD with NOTICES

information,’’ as required by the revised implemented beginning on January 25, normalizing calculations in the
Common Rule’s § 46.116(a)(5)(i). This 2018, and are detailed below. Rescue condition than performed in
will be followed by a discussion of SOH FOR FURTHER INFORMATION CONTACT: other conditions and by omitting
recommendations on the research use of Wanda K. Jones, Ph.D., Interim Director, three data points from the Rescue
repositories and registries under various Office of Research Integrity, 1101 conditions calculated average
consent models, under both the current Wootton Parkway, Suite 750, Rockville, • In Paper 2, Respondent falsified
and the revised Common Rule. The MD 20852, (240) 453–8200. and/or fabricated the research record in:

VerDate Sep<11>2014 18:52 Feb 22, 2018 Jkt 244001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\23FEN1.SGM 23FEN1

Document Created: 2018-02-23 01:32:52
Document Modified: 2018-02-23 01:32:52

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
Action		Notice.
Dates		The meeting will be held on Tuesday, March 13, 2018, from 8:30 a.m. until 5:00 p.m., and Wednesday, March 14, 2018, from 8:30 a.m. until 4:00 p.m.
Contact		Julia Gorey, J.D., Executive Director, SACHRP; U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; telephone: 240-
FR Citation		83 FR 8090