New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline, Procaine Penicillin, and Sulfamethazine, 63053-63054 [2016-21985]
Download as PDF
<![CDATA[
Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Rules and Regulations
Boeing commented that the load
conditions in special condition no. 4, in
Notice no. 25–16–03–SC, which
corresponds to special condition no. 3
in this document, should include all
flight and landing loads, rather than
only emergency landing. These special
conditions are in addition to the load
requirements in the certification basis
for the glass installation, rather than in
lieu of the load requirements. Thus, is
it not necessary to repeat that all of
these loads apply to this installation.
The emergency-landing load condition
is not normally applied to installations
of this type, but for the use of large glass
in the cabin, we determined that this
additional safety standard is necessary.
We made no changes to special
condition number 3 in response to the
Boeing comments.
These special conditions contain the
additional safety standards that the
Administrator considers necessary to
establish a level of safety equivalent to
that established by the existing
airworthiness standards.
Applicability
As discussed above, these special
conditions are applicable to Boeing
Model 737–700 airplanes modified by
Lufthansa. Should Lufthansa apply at a
later date for a supplemental type
certificate to modify any other model
included on Type Certificate No.
A16WE to incorporate the same novel or
unusual design feature, these special
conditions would apply to that model as
well.
Conclusion
This action affects only certain novel
or unusual design features on one model
series of airplane. It is not a rule of
general applicability and affects only
the applicant who applied to the FAA
for approval of these features on the
airplane.
List of Subjects in 14 CFR Part 25
Aircraft, Aviation safety, Reporting
and recordkeeping requirements.
■ The authority citation for these
special conditions is as follows:
asabaliauskas on DSK3SPTVN1PROD with RULES
Authority: 49 U.S.C. 106(g), 40113, 44701,
44702, 44704.
The Special Conditions
Accordingly, pursuant to the
authority delegated to me by the
Administrator, the following special
conditions are issued as part of the type
certification basis for Boeing Model
737–700 airplanes modified by
Lufthansa.
1. Material Fragmentation—The
applicant must use tempered or
otherwise treated glass to ensure that,
VerDate Sep<11>2014
20:49 Sep 13, 2016
Jkt 238001
when fractured, the glass breaks into
small pieces with relatively dull edges.
The glass component installation must
retain all glass fragments to minimize
the danger from flying glass shards or
pieces. The applicant must demonstrate
this characteristic by impact and
puncture testing, and testing to failure.
The applicant may conduct this test
with or without any glass coating that
may be utilized in the design.
2. Strength—In addition to meeting
the load requirements for all flight and
landing loads, including any of the
applicable emergency-landing
conditions in subparts C & D of 14 CFR
part 25, the glass components that are
located such that they are not protected
from contact with cabin occupants must
not fail due to abusive loading, such as
impact from occupants stumbling into,
leaning against, sitting on, or performing
other intentional or unintentional
forceful contact with the glass
component. The applicant must assess
the effect of design details such as
geometric discontinuities or surface
finish, including but not limited to
embossing and etching.
3. Retention—The glass component,
as installed in the airplane, must not
come free of its restraint or mounting
system in the event of an emergency
landing, considering both the
directional loading and resulting
rebound conditions. The applicant must
assess the effect of design details such
as geometric discontinuities or surface
finish, including but not limited to
embossing and etching.
4. Instruction for Continued
Airworthiness—The instructions for
continued airworthiness must reflect the
glass-panel fastening method used, and
must ensure the reliability of the
methods used (e.g., life limit of
adhesives, or clamp connection).
Inspection methods and intervals must
be defined based upon adhesion data
from the manufacturer of the adhesive,
or actual adhesion test data, if
necessary.
Issued in Renton, Washington, on
September 7, 2016.
Michael Kaszycki,
Assistant Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. 2016–22048 Filed 9–13–16; 8:45 am]
BILLING CODE 4910–13–P
PO 00000
Frm 00003
Fmt 4700
Sfmt 4700
63053
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2016–N–0002]
New Animal Drugs for Use in Animal
Feeds; Chlortetracycline and
Sulfamethazine; Chlortetracycline,
Procaine Penicillin, and
Sulfamethazine
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
withdrawal of approval of those parts of
a new animal drug application (NADA)
for a 3-way, fixed-ratio, combination
drug Type A medicated article that
pertain to use of the procaine penicillin
component for production indications
in swine and to reflect the reformulation
of the Type A medicated article as a
2-way, fixed-ratio, combination drug
product without penicillin.
DATES: This rule is effective September
14, 2016.
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–402–
0817, email: cindy.burnsteel@
fda.hhs.gov.
SUMMARY:
Pharmgate
LLC (Pharmgate), 1015 Ashes Dr., Suite
102, Wilmington, NC 28405 has
requested that FDA withdraw approval
of those parts of NADA 138–934 for
PENNCHLOR SP 500 (chlortetracycline,
procaine penicillin, and sulfamethazine)
Type A medicated article that pertain to
use of the procaine penicillin
component for the production
indications of growth promotion and
increased feed efficiency in swine.
Pharmgate requested voluntary
withdrawal of approval of these
indications for use because
PENNCHLOR SP 500 Type A medicated
article is no longer manufactured.
With the withdrawal of approval of
the production indications for procaine
penicillin, the product approved under
NADA 138–934 was reformulated as
PENNCHLOR S 40/40 (chlortetracycline
and sulfamethazine) Type A Medicated
Article, a 2-way, fixed-ratio,
combination drug Type A medicated
article that does not contain penicillin
procaine and is not labeled for
production indications.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\14SER1.SGM
14SER1
63054
Federal Register / Vol. 81, No. 178 / Wednesday, September 14, 2016 / Rules and Regulations
The Agency has determined under 21
CFR 25.33(a) that this action is
categorically excluded from the
requirement to submit an environmental
assessment or an environmental impact
statement because it is of a type that
does not individually or cumulatively
have a significant effect on the human
environment.
Elsewhere in this issue of the Federal
Register, FDA gave notice that the
approval of those parts of NADA 138–
934 pertaining to the procaine penicillin
component indications for growth
promotion and increased feed efficiency
in swine is withdrawn, effective
September 14, 2016. As provided for in
the regulatory text of this document, the
animal drug regulations are amended to
reflect this partial withdrawal of
approval and subsequent product
reformulation.
NADA 138–934 was identified as
being affected by guidance for industry
(GFI) #213 ‘‘New Animal Drugs and
New Animal Drug Combination
Products Administered in or on
Medicated Feed or Drinking Water of
Food-Producing Animals:
Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use
Conditions with GFI #209,’’ December
2013.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Director of the Center for Veterinary
Medicine, 21 CFR part 558 is amended
as follows:
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for part 558
continues to read as follows:
■
asabaliauskas on DSK3SPTVN1PROD with RULES
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
§ 558.140
[Amended]
2. In § 558.140, in paragraph (b)(2),
remove ‘‘No. 054771’’ and in its place
add ‘‘Nos. 054771 and 069254’’.
■
§ 558.145
[Amended]
3. In § 558.145, remove and reserve
paragraph (a)(2).
■
VerDate Sep<11>2014
20:49 Sep 13, 2016
Jkt 238001
Dated: September 6, 2016.
William T. Flynn,
Acting Director, Center for Veterinary
Medicine.
[FR Doc. 2016–21985 Filed 9–13–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
24 CFR Part 100
[Docket No. FR–5248–F–02]
RIN 2529–AA94
Quid Pro Quo and Hostile Environment
Harassment and Liability for
Discriminatory Housing Practices
Under the Fair Housing Act
Office of the Assistant
Secretary for Fair Housing and Equal
Opportunity, HUD.
ACTION: Final rule.
AGENCY:
This final rule amends HUD’s
fair housing regulations to formalize
standards for use in investigations and
adjudications involving allegations of
harassment on the basis of race, color,
religion, national origin, sex, familial
status, or disability. The rule specifies
how HUD will evaluate complaints of
quid pro quo (‘‘this for that’’)
harassment and hostile environment
harassment under the Fair Housing Act.
It will also provide for uniform
treatment of Fair Housing Act claims
raising allegations of quid pro quo and
hostile environment harassment in
judicial and administrative forums. This
rule defines ‘‘quid pro quo’’ and
‘‘hostile environment harassment,’’ as
prohibited under the Fair Housing Act,
and provides illustrations of
discriminatory housing practices that
constitute such harassment. In addition,
this rule clarifies the operation of
traditional principles of direct and
vicarious liability in the Fair Housing
Act context.
DATES: Effective date: October 14, 2016.
FOR FURTHER INFORMATION CONTACT:
Lynn Grosso, Acting Deputy Assistant
Secretary for Enforcement and
Programs, Office of Fair Housing and
Equal Opportunity, Department of
Housing and Urban Development, 451
7th Street SW., Room 5204, Washington
DC 20410–2000; telephone number 202–
402–5361 (this is not a toll-free
number). Persons with hearing or
speech impairments may contact this
number via TTY by calling the toll-free
Federal Relay Service at 800–877–8339.
SUPPLEMENTARY INFORMATION:
SUMMARY:
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
I. Executive Summary
A. Purpose of the Regulatory Action
Both HUD and the courts have long
recognized that Title VIII of the Civil
Rights Act of 1968, as amended, (42
U.S.C. 3601 et seq.) (Fair Housing Act or
Act) prohibits harassment in housing
and housing-related transactions
because of race, color, religion, sex,
national origin, disability,1 and familial
status, just as Title VII of the Civil
Rights Act of 1964 (42 U.S.C. 2000e et
seq.) (Title VII) prohibits such
harassment in employment. But no
standards had been formalized for
assessing claims of harassment under
the Fair Housing Act. Courts have often
applied standards first adopted under
Title VII to evaluate claims of
harassment under the Fair Housing Act,
but there are differences between the
Fair Housing Act and Title VII, and
between harassment in the workplace
and harassment in or around one’s
home, that warrant this rulemaking.
This rule formalizes standards for
evaluating claims of quid pro quo and
hostile environment harassment in the
housing context. The rule does so by
defining ‘‘quid pro quo harassment’’ and
‘‘hostile environment harassment’’ as
conduct prohibited under the Fair
Housing Act, and by specifying the
standards to be used to evaluate
whether particular conduct creates a
quid pro quo or hostile environment in
violation of the Act. Such standards will
apply both in administrative
adjudications and in cases brought in
federal and state courts under the Fair
Housing Act. This rule also adds to
HUD’s existing Fair Housing Act
regulations illustrations of
discriminatory housing practices that
may constitute illegal quid pro quo and
hostile environment harassment.
By establishing consistent standards
for evaluating claims of quid pro quo
and hostile environment harassment,
this rule provides guidance to providers
of housing or housing-related services
seeking to ensure that their properties or
businesses are free of unlawful
harassment. The rule also provides
clarity to victims of harassment and
their representatives regarding how to
assess potential claims of illegal
harassment under the Fair Housing Act.
In addition, this final rule clarifies
when housing providers and other
entities or individuals covered by the
Fair Housing Act may be held directly
or vicariously liable under the Act for
1 This rule uses the term ‘‘disability’’ to refer to
what the Fair Housing Act and its implementing
regulations refer to as ‘‘handicap.’’ Both terms have
the same legal meaning. See Bragdon v. Abbott, 524
U.S. 624, 631 (1998).
E:\FR\FM\14SER1.SGM
14SER1
]]>Agencies
[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Rules and Regulations]
[Pages 63053-63054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21985]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2016-N-0002]
New Animal Drugs for Use in Animal Feeds; Chlortetracycline and
Sulfamethazine; Chlortetracycline, Procaine Penicillin, and
Sulfamethazine
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the withdrawal of approval of those parts
of a new animal drug application (NADA) for a 3-way, fixed-ratio,
combination drug Type A medicated article that pertain to use of the
procaine penicillin component for production indications in swine and
to reflect the reformulation of the Type A medicated article as a 2-
way, fixed-ratio, combination drug product without penicillin.
DATES: This rule is effective September 14, 2016.
FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-0817, email:
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pharmgate LLC (Pharmgate), 1015 Ashes Dr.,
Suite 102, Wilmington, NC 28405 has requested that FDA withdraw
approval of those parts of NADA 138-934 for PENNCHLOR SP 500
(chlortetracycline, procaine penicillin, and sulfamethazine) Type A
medicated article that pertain to use of the procaine penicillin
component for the production indications of growth promotion and
increased feed efficiency in swine. Pharmgate requested voluntary
withdrawal of approval of these indications for use because PENNCHLOR
SP 500 Type A medicated article is no longer manufactured.
With the withdrawal of approval of the production indications for
procaine penicillin, the product approved under NADA 138-934 was
reformulated as PENNCHLOR S 40/40 (chlortetracycline and
sulfamethazine) Type A Medicated Article, a 2-way, fixed-ratio,
combination drug Type A medicated article that does not contain
penicillin procaine and is not labeled for production indications.
[[Page 63054]]
The Agency has determined under 21 CFR 25.33(a) that this action is
categorically excluded from the requirement to submit an environmental
assessment or an environmental impact statement because it is of a type
that does not individually or cumulatively have a significant effect on
the human environment.
Elsewhere in this issue of the Federal Register, FDA gave notice
that the approval of those parts of NADA 138-934 pertaining to the
procaine penicillin component indications for growth promotion and
increased feed efficiency in swine is withdrawn, effective September
14, 2016. As provided for in the regulatory text of this document, the
animal drug regulations are amended to reflect this partial withdrawal
of approval and subsequent product reformulation.
NADA 138-934 was identified as being affected by guidance for
industry (GFI) #213 ``New Animal Drugs and New Animal Drug Combination
Products Administered in or on Medicated Feed or Drinking Water of
Food-Producing Animals: Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use Conditions with GFI #209,'' December
2013.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director of the Center for Veterinary Medicine, 21
CFR part 558 is amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
1. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Sec. 558.140 [Amended]
0
2. In Sec. 558.140, in paragraph (b)(2), remove ``No. 054771'' and in
its place add ``Nos. 054771 and 069254''.
Sec. 558.145 [Amended]
0
3. In Sec. 558.145, remove and reserve paragraph (a)(2).
Dated: September 6, 2016.
William T. Flynn,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-21985 Filed 9-13-16; 8:45 am]
BILLING CODE 4164-01-P
