Determination That VAGIFEM (Estradiol) Vaginal Tablets, 25 Micrograms, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 29720-29721 [2015-12396]
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29720
Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices
343(r)(3)(A)) provides for the use of food
label statements characterizing a
relationship of any nutrient of the type
required to be in the label or labeling of
the food to a disease or a health related
condition only where that statement
meets the requirements of the
regulations promulgated by the
Secretary of Health and Human Services
to authorize the use of such a health
claim. Section 101.82 (21 CFR 101.82) of
our regulations authorizes a health
claim for food labels about soy protein
and the risk of coronary heart disease
(CHD). To bear the soy protein and CHD
health claim, foods must contain at least
6.25 grams of soy protein per reference
amount customarily consumed.
Analytical methods for measuring total
protein can be used to quantify the
amount of soy protein in foods that
contain soy as the sole source of protein.
However, at the present time there is no
validated analytical methodology
available to quantify the amount of soy
protein in foods that contain other
sources of protein. For these latter
foods, we must rely on information
known only to the manufacturer to
assess compliance with the requirement
that the food contain the qualifying
amount of soy protein. Thus, we require
manufacturers to have and keep records
to substantiate the amount of soy
protein in a food that bears the health
claim and contains sources of protein
other than soy, and to make such
records available to appropriate
regulatory officials upon written
request. The information collected
includes nutrient databases or analyses,
recipes or formulations, purchase orders
for ingredients, or any other information
that reasonably substantiates the ratio of
soy protein to total protein.
In the Federal Register of March 10,
2015 (80 FR 12640), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the annual burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
101.82(c)(2)(ii)(B) .................................................................
25
1
25
1
25
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based upon our experience with the
use of health claims, we estimate that
only about 25 firms would be likely to
market products bearing a soy protein/
coronary heart disease health claim and
that only, perhaps, one of each firm’s
products might contain non-soy sources
of protein along with soy protein. The
records required to be retained by
§ 101.82(c)(2)(ii)(B) are the records, e.g.,
the formulation or recipe, that a
manufacturer has and maintains as a
normal course of its doing business.
Thus, the burden to the food
manufacturer is limited to assembling
and retaining the records, which we
estimate will take 1 hour annually.
Dated: May 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–12402 Filed 5–21–15; 08:45 am]
BILLING CODE 4164–01–P
The Food and Drug
Administration (FDA or Agency) has
determined that VAGIFEM (estradiol)
Vaginal Tablets, 25 micrograms, was 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 this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Elaine Lippmann, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6214,
Silver Spring, MD 20993–0002, 301–
796–3602, Elaine.Lippmann@
fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSK5VPTVN1PROD with NOTICES
[Docket No. FDA–2011–P–0482]
Determination That VAGIFEM
(Estradiol) Vaginal Tablets, 25
Micrograms, Was Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
18:19 May 21, 2015
Jkt 235001
PO 00000
Frm 00119
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\22MYN1.SGM
22MYN1
Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices
29721
FDA has become aware that the drug
product listed in the table in this
document is no longer being marketed.
Application No.
Drug
Applicant
NDA 020908 .......
VAGIFEM (estradiol) Vaginal Tablets, 25 micrograms ...........
Novo Nordisk Inc., 800 Scudders Mill Rd., Plainsboro, NJ
08536.
FDA has reviewed its records and,
under § 314.161, has determined that
the drug product listed in this document
was not withdrawn from sale for reasons
of safety or effectiveness. Accordingly,
the Agency will continue to list the drug
product 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
NDA listed in this document are
unaffected by the discontinued
marketing of the product subject to this
NDA. Additional ANDAs that refer to
this product may also be approved by
the Agency if they comply with relevant
legal and regulatory requirements. If
FDA determines that labeling for
estradiol vaginal tablets should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: May 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On March
17, 2015, the Agency submitted a
proposed collection of information
entitled, ‘‘Substances Prohibited From
Use in Animal Food or Feed’’ to OMB
for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0627. The
approval expires on April 30, 2018. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: May 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–12404 Filed 5–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2011–N–0510]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry: Notification of a
Health Claim or Nutrient Content Claim
Based on an Authoritative Statement
of a Scientific Body
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Substances Prohibited From Use in
Animal Food or Feed
Food and Drug Administration,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
HHS.
AGENCY:
Food and Drug Administration,
HHS.
Notice.
ACTION:
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled,
‘‘Substances Prohibited From Use in
Animal Food or Feed’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
SUMMARY:
VerDate Sep<11>2014
18:19 May 21, 2015
Jkt 235001
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2011–N–0535]
ACTION:
[FR Doc. 2015–12400 Filed 5–21–15; 8:45 am]
Food and Drug Administration
Food and Drug Administration
AGENCY:
On March
13, 2015, the Agency submitted a
proposed collection of information
entitled, ‘‘Guidance for Industry:
Notification of a Health Claim or
Nutrient Content Claim Based on an
Authoritative Statement of a Scientific
Body’’ to OMB for review and clearance
under 44 U.S.C. 3507. An Agency may
not conduct or sponsor, and a person is
not required to respond to, a collection
of information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0374. The
approval expires on April 30, 2018. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: May 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
[FR Doc. 2015–12396 Filed 5–21–15; 8:45 am]
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
[Docket No. FDA–2015–N–0001]
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled,
‘‘Guidance for Industry: Notification of
a Health Claim or Nutrient Content
Claim Based on an Authoritative
Statement of a Scientific Body’’ has
been approved by the Office of
Frm 00120
Fmt 4703
Sfmt 4703
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY:
PO 00000
Food and Drug Administration
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Oncologic Drugs
Advisory Committee.
General Function of the Committee:
To provide advice and
E:\FR\FM\22MYN1.SGM
22MYN1
]]>Agencies
[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29720-29721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12396]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-P-0482]
Determination That VAGIFEM (Estradiol) Vaginal Tablets, 25
Micrograms, Was 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 VAGIFEM (estradiol) Vaginal Tablets, 25 micrograms, was
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
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Elaine Lippmann, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6214, Silver Spring, MD 20993-0002, 301-
796-3602, Elaine.Lippmann@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 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.
[[Page 29721]]
FDA has become aware that the drug product listed in the table in
this document is no longer being marketed.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 020908................. VAGIFEM (estradiol) Novo Nordisk Inc.,
Vaginal Tablets, 25 800 Scudders Mill
micrograms. Rd., Plainsboro, NJ
08536.
------------------------------------------------------------------------
FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug product listed in this document was not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug product 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 NDA listed in this document are
unaffected by the discontinued marketing of the product subject to this
NDA. Additional ANDAs that refer to this product may also be approved
by the Agency if they comply with relevant legal and regulatory
requirements. If FDA determines that labeling for estradiol vaginal
tablets should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.
Dated: May 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12396 Filed 5-21-15; 8:45 am]
BILLING CODE 4164-01-P
