Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim, 29719-29720 [2015-12402]
Download as PDF
<![CDATA[
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 99 / Friday, May 22, 2015 / Notices
drug products for identification as
demonstrably difficult to compound.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before June 9, 2015. Oral
presentations from the public will be
scheduled between approximately 11
a.m. to 11:15 a.m. and 3:45 p.m. to 4
p.m. on June 17, 2015, and between
approximately 9:15 a.m. to 9:45 a.m. on
June 18, 2015. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before June 4,
2015. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by June 8, 2015.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Jayne E.
Peterson at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
VerDate Sep<11>2014
18:19 May 21, 2015
Jkt 235001
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: May 19, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–12512 Filed 5–21–15; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0639]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Requests for Inspection by an
Accredited Person Under the
Inspection by Accredited Persons
Program
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Requests for Inspection by an
Accredited Person under the Inspection
by Accredited Persons Program’’ has
been approved by the Office of
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.
SUMMARY:
On
December 3, 2014, the Agency
submitted a proposed collection of
information entitled ‘‘Requests for
Inspection by an Accredited Person
under the Inspection by Accredited
Persons Program’’ 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 0910–0569.
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:
PO 00000
Frm 00118
Fmt 4703
Dated: May 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–12399 Filed 5–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0781]
BILLING CODE 4164–01–P
AGENCY:
29719
Sfmt 4703
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Record Retention
Requirements for the Soy Protein and
Risk of Coronary Heart Disease Health
Claim
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 22,
2015.
ADDRESSES: 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 0910–0428. Also
include the FDA docket number found
in brackets in the heading of this
document.
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.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Record Retention Requirements for
the Soy Protein and Risk of Coronary
Heart Disease Health
SUMMARY:
Claim—21 CFR 101.82(c)(2)(ii)(B)
OMB Control Number 0910–0428—
Extension
Section 403(r)(3)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
E:\FR\FM\22MYN1.SGM
22MYN1
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
]]>Agencies
[Federal Register Volume 80, Number 99 (Friday, May 22, 2015)]
[Notices]
[Pages 29719-29720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12402]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0781]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Record Retention
Requirements for the Soy Protein and Risk of Coronary Heart Disease
Health Claim
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by June
22, 2015.
ADDRESSES: 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 0910-0428.
Also include the FDA docket number found in brackets in the heading of
this document.
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.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Record Retention Requirements for the Soy Protein and Risk of
Coronary Heart Disease Health
Claim--21 CFR 101.82(c)(2)(ii)(B)
OMB Control Number 0910-0428--Extension
Section 403(r)(3)(A) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C.
[[Page 29720]]
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 Sec. 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
