Determination That QUESTRAN (Cholestyramine for Oral Suspension, USP), Equivalent to 4 Grams, and QUESTRAN LIGHT (Cholestyramine for Oral Suspension, USP), Equivalent to 4 Grams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 18352-18353 [2013-06825]
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18352
Federal Register / Vol. 78, No. 58 / Tuesday, March 26, 2013 / Notices
Fax written comments on the
collection of information by April 25,
2013.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0331. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5733, domini.bean@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Food Labeling; Notification Procedures
for Statements on Dietary
Supplements—21 CFR 101.93 (OMB
Control Number 0910–0331)—Extension
Section 403(r)(6) of the FD&C Act (21
U.S.C. 343(r)(6)) requires that FDA be
notified by manufacturers, packers, and
distributors of dietary supplements that
they are marketing a dietary supplement
product that bears on its label or in its
labeling a statement provided for in
section 403(r)(6). Section 403(r)(6) of the
FD&C Act requires that FDA be notified,
with a submission about such
statements, no later than 30 days after
the first marketing of the dietary
supplement. Information that is
required in the submission includes: (1)
The name and address of the
manufacturer, packer, or distributor of
the dietary supplement product; (2) the
text of the statement that is being made;
(3) the name of the dietary ingredient or
supplement that is the subject of the
statement; (4) the name of the dietary
supplement (including the brand name);
and (5) a signature of a responsible
individual who can certify the accuracy
of the information presented, and who
must certify that the information
contained in the notice is complete and
accurate, and that the notifying firm has
substantiation that the statement is
truthful and not misleading.
The procedural regulation for this
program is codified at 21 CFR 101.93.
Section 101.93 provides submission
procedures and identifies the
information that must be included in
order to meet the requirements of
section 403 of the FD&C Act.
Description of Respondents:
Respondents to this collection of
information include manufacturers,
packers, or distributors of dietary
supplements that bear section 403(r)(6)
of the FD&C Act statements on their
labels or labeling.
In the Federal Register of January 18,
2013 (78 FR 4153), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received one letter in
response to the notice. One comment in
the letter suggested that electronic
submission could potentially decrease
the reporting burden. FDA agrees and is
in the process of developing a method
of receiving submissions electronically.
FDA estimates the 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
101.93
2,200
1
2,200
0.75
1,650
srobinson on DSK4SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We believe that there will be minimal
burden on the industry to generate
information to meet the requirements of
section 403 of the FD&C Act in
submitting information regarding
section 403(r)(6) statements on labels or
in labeling of dietary supplements. We
are requesting only information that is
immediately available to the
manufacturer, packer, or distributor of
the dietary supplement that bears such
a statement on its label or in its labeling.
We estimate that, each year,
approximately 2,200 firms will submit
the information required by section 403
of the FD&C Act. We estimate that a firm
will require 0.75 hours to gather the
information needed and prepare a
submission, for a total of 1,650 hours
(2,200 × 0.75). This estimate is based on
the average number of notification
submissions received by us in the
preceding 3 years.
Dated: March 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–06823 Filed 3–25–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–P–0649]
Determination That QUESTRAN
(Cholestyramine for Oral Suspension,
USP), Equivalent to 4 Grams, and
QUESTRAN LIGHT (Cholestyramine for
Oral Suspension, USP), Equivalent to 4
Grams, Were Not Withdrawn From Sale
for Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
19:07 Mar 25, 2013
Jkt 229001
PO 00000
Frm 00048
Fmt 4703
FOR FURTHER INFORMATION CONTACT:
Carolina M. Wirth, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6282,
Silver Spring, MD 20993–0002, 301–
796–3602.
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
SUPPLEMENTARY INFORMATION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
VerDate Mar<15>2010
that QUESTRAN (cholestyramine for
oral suspension, USP), equivalent to
(EQ) 4 grams (g), and QUESTRAN
LIGHT (cholestyramine for oral
suspension, USP), EQ 4 g, were not
withdrawn from sale for reasons of
safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of the abbreviated new drug
applications (ANDAs) that refer to these
drugs, and it will allow FDA to approve
ANDAs that refer to these drugs as long
as they meet relevant legal and
regulatory requirements.
Sfmt 4703
E:\FR\FM\26MRN1.SGM
26MRN1
srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 58 / Tuesday, March 26, 2013 / Notices
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products 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 only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
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 known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are 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).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
QUESTRAN (cholestyramine for oral
suspension, USP), EQ 4 g, is the subject
of NDA 16–640, held by Bristol-Myers
Squibb, and initially approved on
August 3, 1973. QUESTRAN LIGHT
(cholestyramine for oral suspension,
USP), EQ 4 g, is the subject of NDA 19–
669, also held by Bristol-Myers Squibb,
and initially approved on December 5,
1988. QUESTRAN and QUESTRAN
LIGHT are indicated as adjunctive
therapy for the reduction of elevated
serum cholesterol in patients with
primary hypercholesterolemia (elevated
low-density lipoprotein cholesterol)
who do not respond adequately to diet.
In a letter dated May 31, 2012, BristolMyers Squibb notified FDA that
QUESTRAN (cholestyramine for oral
suspension, USP), EQ 4 g, and
QUESTRAN LIGHT (cholestyramine for
oral suspension, USP), EQ 4 g, were
VerDate Mar<15>2010
19:07 Mar 25, 2013
Jkt 229001
being discontinued, and FDA moved the
drug products to the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. Lachman Consultant Services,
Inc., submitted a citizen petition dated
June 19, 2012 (Docket No. FDA–2012–
P–0649), under 21 CFR 10.30,
requesting that the Agency determine
whether QUESTRAN (cholestyramine
for oral suspension, USP), EQ 4 g, was
withdrawn from sale for reasons of
safety or effectiveness. Although the
citizen petition did not address
QUESTRAN LIGHT, that version of the
drug product has also been
discontinued. On our own initiative, we
have also determined whether
QUESTRAN LIGHT was withdrawn for
safety or effectiveness reasons.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that QUESTRAN
(cholestyramine for oral suspension,
USP), EQ 4 g, and QUESTRAN LIGHT
(cholestyramine for oral suspension,
USP), EQ 4 g, were not withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
QUESTRAN (cholestyramine for oral
suspension, USP), EQ 4 g, and
QUESTRAN LIGHT (cholestyramine for
oral suspension, USP), EQ 4 g, from
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have found no information
that would indicate that either product
was withdrawn from sale for reasons of
safety or effectiveness. Moreover, the
petitioner has identified no data or other
information suggesting that QUESTRAN
(cholestyramine for oral suspension,
USP), EQ 4 g, was withdrawn for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list QUESTRAN
(cholestyramine for oral suspension,
USP), EQ 4 g, and QUESTRAN LIGHT
(cholestyramine for oral suspension,
USP), EQ 4 g, in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness. FDA
will not begin procedures to withdraw
approval of the approved ANDAs that
refer to QUESTRAN or QUESTRAN
LIGHT. Additional ANDAs for
cholestyramine and cholestyramine
light for oral suspension, USP, EQ 4 g,
may also be approved by the Agency as
long as they meet all other legal and
regulatory requirements for the approval
of ANDAs. If FDA determines that
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
18353
labeling for these drug products should
be revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: March 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–06825 Filed 3–25–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0069; (Formerly
FDA–2007D–0393)]
Guidance for Industry: Blood
Establishment Computer System
Validation in the User’s Facility;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a document entitled
‘‘Guidance for Industry: Blood
Establishment Computer System
Validation in the User’s Facility’’ dated
April 2013. The guidance document
provides assistance to blood
establishments in developing a blood
establishment computer system
validation program, consistent with
recognized principles of software
validation, quality assurance, and
current good software engineering
practices. The guidance announced in
this document finalizes the draft
guidance of the same title dated October
2007.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, Suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The guidance may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
E:\FR\FM\26MRN1.SGM
26MRN1
]]>Agencies
[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Notices]
[Pages 18352-18353]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06825]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-P-0649]
Determination That QUESTRAN (Cholestyramine for Oral Suspension,
USP), Equivalent to 4 Grams, and QUESTRAN LIGHT (Cholestyramine for
Oral Suspension, USP), Equivalent to 4 Grams, 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) has determined that
QUESTRAN (cholestyramine for oral suspension, USP), equivalent to (EQ)
4 grams (g), and QUESTRAN LIGHT (cholestyramine for oral suspension,
USP), EQ 4 g, were not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of the abbreviated new drug
applications (ANDAs) that refer to these drugs, and it will allow FDA
to approve ANDAs that refer to these drugs as long as they meet
relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Carolina M. Wirth, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6282, Silver Spring, MD 20993-0002, 301-
796-3602.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
[[Page 18353]]
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products 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 only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
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 known generally as the ``Orange
Book.'' Under FDA regulations, drugs are 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).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
QUESTRAN (cholestyramine for oral suspension, USP), EQ 4 g, is the
subject of NDA 16-640, held by Bristol-Myers Squibb, and initially
approved on August 3, 1973. QUESTRAN LIGHT (cholestyramine for oral
suspension, USP), EQ 4 g, is the subject of NDA 19-669, also held by
Bristol-Myers Squibb, and initially approved on December 5, 1988.
QUESTRAN and QUESTRAN LIGHT are indicated as adjunctive therapy for the
reduction of elevated serum cholesterol in patients with primary
hypercholesterolemia (elevated low-density lipoprotein cholesterol) who
do not respond adequately to diet.
In a letter dated May 31, 2012, Bristol-Myers Squibb notified FDA
that QUESTRAN (cholestyramine for oral suspension, USP), EQ 4 g, and
QUESTRAN LIGHT (cholestyramine for oral suspension, USP), EQ 4 g, were
being discontinued, and FDA moved the drug products to the
``Discontinued Drug Product List'' section of the Orange Book. Lachman
Consultant Services, Inc., submitted a citizen petition dated June 19,
2012 (Docket No. FDA-2012-P-0649), under 21 CFR 10.30, requesting that
the Agency determine whether QUESTRAN (cholestyramine for oral
suspension, USP), EQ 4 g, was withdrawn from sale for reasons of safety
or effectiveness. Although the citizen petition did not address
QUESTRAN LIGHT, that version of the drug product has also been
discontinued. On our own initiative, we have also determined whether
QUESTRAN LIGHT was withdrawn for safety or effectiveness reasons.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that QUESTRAN (cholestyramine for oral suspension,
USP), EQ 4 g, and QUESTRAN LIGHT (cholestyramine for oral suspension,
USP), EQ 4 g, were not withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of QUESTRAN (cholestyramine for oral
suspension, USP), EQ 4 g, and QUESTRAN LIGHT (cholestyramine for oral
suspension, USP), EQ 4 g, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have found no information that would indicate that
either product was withdrawn from sale for reasons of safety or
effectiveness. Moreover, the petitioner has identified no data or other
information suggesting that QUESTRAN (cholestyramine for oral
suspension, USP), EQ 4 g, was withdrawn for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list QUESTRAN
(cholestyramine for oral suspension, USP), EQ 4 g, and QUESTRAN LIGHT
(cholestyramine for oral suspension, USP), EQ 4 g, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. FDA will not begin procedures to withdraw
approval of the approved ANDAs that refer to QUESTRAN or QUESTRAN
LIGHT. Additional ANDAs for cholestyramine and cholestyramine light for
oral suspension, USP, EQ 4 g, may also be approved by the Agency as
long as they meet all other legal and regulatory requirements for the
approval of ANDAs. 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: March 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06825 Filed 3-25-13; 8:45 am]
BILLING CODE 4160-01-P
