Determination That APRESOLINE (Hydralazine Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 36312-36313 [2016-13181]
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36312
Federal Register / Vol. 81, No. 108 / Monday, June 6, 2016 / Notices
known, distribution, disposition, or
expiration of the tissue, whichever is
the latest. Section 1270.35(a) through (d)
requires specific records to be
maintained to document the following:
(1) The results and interpretation of all
required infectious disease tests; (2)
information on the identity and relevant
medical records of the donor; (3) the
receipt and/or distribution of human
tissue, and (4) the destruction or other
disposition of human tissue.
Respondents to this collection of
information are manufacturers of human
tissue intended for transplantation.
Based on information from the Center
for Biologics Evaluation and Research’s
(CBER’s) database system, FDA
estimates that there are approximately
383 tissue establishments of which 262
are conventional tissue banks and 121
are eye tissue banks. Based on
information provided by industry, there
are an estimated total of 2,141,960
conventional tissue products and
130,987 eye tissue products distributed
per year with an average of 25 percent
of the tissue discarded due to
unsuitability for transplant. In addition,
there are an estimated 29,799 deceased
donors of conventional tissue and
70,027 deceased donors of eye tissue
each year.
Accredited members of the American
Association of Tissue Banks (AATB)
and Eye Bank Association of America
(EBAA) adhere to standards of those
organizations that are comparable to the
recordkeeping requirements in part
1270. Based on information provided by
CBER’s database system, 90 percent of
the conventional tissue banks are
members of AATB (262 × 90% = 236),
and 95 percent of eye tissue banks are
members of EBAA (121 × 95% = 115).
Therefore, recordkeeping by these 351
establishments (236 + 115 = 351) is
excluded from the burden estimates as
usual and customary business activities
(5 CFR 1320.3(b)(2)). The recordkeeping
burden, thus, is estimated for the
remaining 32 establishments, which is
8.36 percent of all establishments (383
¥ 351 = 32, or 32/383 = 8.36%).
FDA assumes that all current tissue
establishments have developed written
procedures in compliance with part
1270. Therefore, their information
collection burden is for the general
review and update of written
procedures estimated to take an annual
average of 24 hours, and for the
recording and justifying of any
deviations from the written procedures
under § 1270.31(a) and (b), estimated to
take an annual average of 1 hour. The
information collection burden for
maintaining records concurrently with
the performance of each significant
screening and testing step and for
retaining records for 10 years under
§ 1270.33(a), (f), and (h) include
documenting the results and
interpretation of all required infectious
disease tests and results and the identity
and relevant medical records of the
donor required under § 1270.35(a) and
(b). Therefore, the burden under these
provisions is calculated together in table
1 of this document. The recordkeeping
estimates for the number of total annual
records and hours per record are based
on information provided by industry
and FDA experience.
FDA estimates the burden of this
information collection as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
1270.31(a), (b), (c), and (d) 2 ...............................................
1270.31(a) and 1270.31(b) 3 ................................................
1270.33(a), (f), and (h), and 1270.35(a) and (b) .................
1270.35(c) ............................................................................
1270.35(d) ............................................................................
32
32
32
32
32
1
2
6,198.84
11,876.12
1,454.50
32
64
198,363
380,036
47,504
24
1
1.0
1.0
1.0
768
64
198,363
380,036
47,504
Total ..............................................................................
........................
........................
........................
........................
626,735
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
and update of standard operating procedures (SOPs).
3 Documentation of deviations from SOPs.
2 Review
Dated: May 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–13224 Filed 6–3–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sradovich on DSK3TPTVN1PROD with NOTICES
[Docket No. FDA–2016–N–1284]
Determination That APRESOLINE
(Hydralazine Hydrochloride) Injectable
and Other Drug Products Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
16:36 Jun 03, 2016
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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
refer to the products as long as they
meet relevant legal and regulatory
requirements.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@fda.hhs.gov.
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
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.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 81, No. 108 / Monday, June 6, 2016 / Notices
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
Application No.
Drug name
Active ingredient(s)
NDA 008303 ..........
APRESOLINE ......
Hydralazine Hydrochloride;
NDA 017853 ..........
PROVENTIL .........
Albuterol Sulfate ..................
NDA 019439 ..........
K-Dur ....................
Potassium Chloride .............
ANDA 060572 .......
MYCOLOG–II .......
ANDA 084343 .......
KENALOG ............
Nystatin; Triamcinolone
Acetonide.
Triamcinolone Acetonide .....
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed in this
document were not withdrawn from
sale for reasons of safety or
effectiveness. Accordingly, the Agency
will continue to list the drug products
listed in this document in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
NDAs and ANDAs listed in this
document are unaffected by the
discontinued marketing of the products
subject to those NDAs and ANDAs.
Additional ANDAs that refer to these
products may also be approved by the
Agency if they comply with relevant
legal and regulatory requirements. If
FDA determines that labeling for these
drug products should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
sradovich on DSK3TPTVN1PROD with NOTICES
[FR Doc. 2016–13181 Filed 6–3–16; 8:45 am]
BILLING CODE 4164–01–P
Strength(s)
Dosage form/route
20 milligrams (mg)/milliliter
10 mg; 25 mg; 50 mg;
100 mg.
Equivalent to (EQ) 2 mg
base; EQ 4 mg base.
10 milliequivalents (meq); 20
meq.
100,000 units/gram; 0.1% ...
0.025%; 0.1% ......................
Novartis Pharmaceuticals
Corp.
Tablet; Oral ..........................
Schering-Plough Corp.
Extended-Release Tablet;
Oral.
Ointment; Topical ................
Merck Sharp & Dohme,
Corp.
Delcor Asset Corp.
Lotion; Topical .....................
Delcor Asset Corp.
Food and Drug Administration
[Docket No. FDA–2016–D–0643]
Labeling for Biosimilar Products; Draft
Guidance for Industry; Availability;
Extension of Comment Period
Food and Drug Administration,
HHS.
Notice of availability; extension
of comment period.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
extending the comment period for the
notice entitled ‘‘Labeling for Biosimilar
Products; Draft Guidance for Industry;
Availability’’ that appeared in the
Federal Register of April 4, 2016. The
Agency is taking this action to allow
interested persons additional time to
submit comments.
DATES: FDA is extending the comment
period for the notice that published on
April 4, 2016 (81 FR 19194) by an
additional 60 days. Although you can
comment on any guidance at any time
(see 21 CFR 10.115(g)(5)), to permit the
Agency to consider your comments
before issuing the final version of the
guidance, submit either electronic or
written comments on the draft guidance
by August 2, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
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Applicant
Injectable; Injection Tablet;
Oral.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
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 following table are
no longer being marketed.
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
E:\FR\FM\06JNN1.SGM
06JNN1
Agencies
[Federal Register Volume 81, Number 108 (Monday, June 6, 2016)]
[Notices]
[Pages 36312-36313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13181]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-1284]
Determination That APRESOLINE (Hydralazine Hydrochloride)
Injectable and Other Drug Products Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 refer to the products as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, 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.
[[Page 36313]]
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 Sec. 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 following
table are no longer being marketed.
----------------------------------------------------------------------------------------------------------------
Active Dosage form/
Application No. Drug name ingredient(s) Strength(s) route Applicant
----------------------------------------------------------------------------------------------------------------
NDA 008303........... APRESOLINE........... Hydralazine 20 milligrams Injectable; Novartis
Hydrochloride;. (mg)/ Injection Pharmaceutical
milliliter 10 Tablet; Oral. s Corp.
mg; 25 mg; 50
mg; 100 mg.
NDA 017853........... PROVENTIL............ Albuterol Equivalent to Tablet; Oral... Schering-Plough
Sulfate. (EQ) 2 mg Corp.
base; EQ 4 mg
base.
NDA 019439........... K-Dur................ Potassium 10 Extended- Merck Sharp &
Chloride. milliequivalen Release Dohme, Corp.
ts (meq); 20 Tablet; Oral.
meq.
ANDA 060572.......... MYCOLOG-II........... Nystatin; 100,000 units/ Ointment; Delcor Asset
Triamcinolone gram; 0.1%. Topical. Corp.
Acetonide.
ANDA 084343.......... KENALOG.............. Triamcinolone 0.025%; 0.1%... Lotion; Topical Delcor Asset
Acetonide. Corp.
----------------------------------------------------------------------------------------------------------------
FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
Approved ANDAs that refer to the NDAs and ANDAs listed in this
document are unaffected by the discontinued marketing of the products
subject to those NDAs and ANDAs. Additional ANDAs that refer to these
products may also be approved by the Agency if they comply with
relevant legal and regulatory requirements. If FDA determines that
labeling for these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.
Dated: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13181 Filed 6-3-16; 8:45 am]
BILLING CODE 4164-01-P