Guidance for Industry on Evaluating the Safety of Flood-Affected Food Crops for Human Consumption; Availability, 65734-65735 [2011-27382]
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65734
Federal Register / Vol. 76, No. 205 / Monday, October 24, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR WATER SOLUBLE POWDERS 1
Number of Respondents
Number of Responses per
Respondent
Same Formulation/Manufacturing Process Approach .........
Same API/Solubility Approach .............................................
1
5
1
5
1
5
5
10
5
50
Total Burden Hours ......................................................
........................
........................
........................
........................
55
1 There
Total Annual
Responses
Average Burden per Response
Total Hours
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR TYPE A MEDICATED ARTICLES 1
No. of Responses per
Respondent
No. of Respondents
Total Annual
Responses
Average Burden per Response
Total Hours
Same Formulation/Manufacturing Process Approach .........
Same API/Solubility Approach .............................................
2
10
2
10
2
10
5
20
10
200
Total Burden Hours ......................................................
........................
........................
........................
........................
210
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–27392 Filed 10–21–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0733]
Guidance for Industry on Evaluating
the Safety of Flood-Affected Food
Crops for Human Consumption;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled
‘‘Guidance for Industry: Evaluating the
Safety of Flood-Affected Food Crops for
Human Consumption.’’ Flooding events
can present a potentially hazardous
public health risk. Flood waters may
have been exposed to sewage,
chemicals, heavy metals, pathogenic
microorganisms, or other contaminants.
The growers are responsible to ensure
the safety of the flood-affected food
crops. The guidance is intended to
provide growers information on how to
evaluate the safety of flood-affected food
crops for human consumption.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Plant and Dairy Food Safety,
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:34 Oct 21, 2011
Jkt 226001
Center for Food Safety and Applied
Nutrition (HFS–317), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
one self-addressed adhesive label to
assist that office in processing your
requests. 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–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Yinqing Ma, Center for Food Safety and
Applied Nutrition/Office of Food Safety,
Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD,
240–402–2479.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Evaluating the Safety of Flood-affected
Food Crops for Human Consumption’’
This guidance is being issued consistent
with FDA’s good guidance practices
(GGP) regulation (§ 10.115 (21 CFR
10.115)). This guidance is being
implemented without prior public
comment because the Agency has
determined that prior public
participation is not feasible or
appropriate (§ 10.115(g)(2)). The Agency
made this determination because the
guidance deals with highly timesensitive issues and requires immediate
implementation for public health
reasons. Although this guidance
document is immediately in effect, it
remains subject to comment in
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
accordance with the Agency’s GGPs
regulation.
The guidance is intended to provide
growers information on how to evaluate
the safety of flood-affected food crops
for human consumption. The
recommendations in this guidance are
consistent with existing FDA’s positions
on the safety of flood-affected food
crops. This guidance reiterates FDA’s
positions and includes additional
information to help growers assess the
safety of food from flood-affected crops
for human consumption. Specifically,
the guidance addresses: (1) Safety of
food crops when flood waters contacted
the edible portions of the crops, (2)
safety of food crops when flood waters
did not contact the edible portions of
the crops, (3) assessment of floodaffected fields before replanting, and (4)
additional controls to avoid crosscontamination after flooding.
The guidance represents the Agency’s
current thinking on the safety of floodaffected food crops for human
consumption. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
E:\FR\FM\24OCN1.SGM
24OCN1
Federal Register / Vol. 76, No. 205 / Monday, October 24, 2011 / Notices
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov. Always access an
FDA guidance document by using
FDA’s Web site listed previously to find
the most current version of the
guidance.
Dated: October 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–27382 Filed 10–21–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0722]
Draft Guidance for Industry:
Implementation of Acceptable
Abbreviated Donor History
Questionnaire and Accompanying
Materials for Use in Screening
Frequent Donors of Blood and Blood
Components; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft document entitled
‘‘Guidance for Industry: Implementation
of Acceptable Abbreviated Donor
History Questionnaire and
Accompanying Materials for Use in
Screening Frequent Donors of Blood and
Blood Components’’ dated October
2011. The draft guidance document
recognizes the abbreviated donor history
questionnaire and accompanying
materials (aDHQ documents), version
1.3 dated August 2011, as an acceptable
mechanism for collecting blood donor
history information from frequent
donors of blood and blood components
that is consistent with FDA’s
requirements and recommendations for
collecting donor history information.
The aDHQ documents will provide
blood establishments that collect blood
and blood components with a specific
process for administering questions to
frequent donors of blood and blood
components to determine their
eligibility to donate.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:34 Oct 21, 2011
Jkt 226001
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by January 23,
2012.
ADDRESSES: Submit written requests for
single copies of the draft 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 draft 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 draft guidance
document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Implementation of Acceptable
Abbreviated Donor History
Questionnaire and Accompanying
Materials for Use in Screening Frequent
Donors of Blood and Blood
Components’’ dated October 2011. The
draft guidance document recognizes the
aDHQ documents, version 1.3 dated
August 2011, prepared by the AABB
Donor History Task Force, as an
acceptable mechanism for collecting
blood donor history information from
frequent donors of blood and blood
components that is consistent with
FDA’s requirements and
recommendations. The aDHQ
documents will provide blood
establishments that collect blood and
blood components with a specific
process for administering questions to
frequent donors of blood and blood
components to determine their
eligibility to donate. The guidance also
advises licensed manufacturers who
choose to implement the acceptable
aDHQ documents on how to report the
manufacturing change consisting of the
PO 00000
Frm 00055
Fmt 4703
Sfmt 9990
65735
implementation of the aDHQ documents
under 21 CFR 601.12.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the requirement
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
The draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR 601.12 have
been approved under OMB Control No.
0910–0338; the collections of
information in 21 CFR 606.171 have
been approved under OMB Control No.
0910–0458; and the collections of
information in 21 CFR 640.3 have been
approved under OMB Control No. 0910–
0116.
III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments
regarding this document. It is only
necessary to send one set of comments.
It is no longer necessary to send two
copies of mailed comments. Identify
comments with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: October 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–27381 Filed 10–21–11; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\24OCN1.SGM
24OCN1
]]>Agencies
[Federal Register Volume 76, Number 205 (Monday, October 24, 2011)]
[Notices]
[Pages 65734-65735]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27382]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0733]
Guidance for Industry on Evaluating the Safety of Flood-Affected
Food Crops for Human Consumption; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance for Industry: Evaluating
the Safety of Flood-Affected Food Crops for Human Consumption.''
Flooding events can present a potentially hazardous public health risk.
Flood waters may have been exposed to sewage, chemicals, heavy metals,
pathogenic microorganisms, or other contaminants. The growers are
responsible to ensure the safety of the flood-affected food crops. The
guidance is intended to provide growers information on how to evaluate
the safety of flood-affected food crops for human consumption.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Plant and Dairy Food Safety, Center for Food Safety
and Applied Nutrition (HFS-317), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740. Send one self-addressed
adhesive label to assist that office in processing your requests. 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-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Yinqing Ma, Center for Food Safety and
Applied Nutrition/Office of Food Safety, Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD, 240-402-2479.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Evaluating the Safety of Flood-affected Food Crops for Human
Consumption'' This guidance is being issued consistent with FDA's good
guidance practices (GGP) regulation (Sec. 10.115 (21 CFR 10.115)).
This guidance is being implemented without prior public comment because
the Agency has determined that prior public participation is not
feasible or appropriate (Sec. 10.115(g)(2)). The Agency made this
determination because the guidance deals with highly time-sensitive
issues and requires immediate implementation for public health reasons.
Although this guidance document is immediately in effect, it remains
subject to comment in accordance with the Agency's GGPs regulation.
The guidance is intended to provide growers information on how to
evaluate the safety of flood-affected food crops for human consumption.
The recommendations in this guidance are consistent with existing FDA's
positions on the safety of flood-affected food crops. This guidance
reiterates FDA's positions and includes additional information to help
growers assess the safety of food from flood-affected crops for human
consumption. Specifically, the guidance addresses: (1) Safety of food
crops when flood waters contacted the edible portions of the crops, (2)
safety of food crops when flood waters did not contact the edible
portions of the crops, (3) assessment of flood-affected fields before
replanting, and (4) additional controls to avoid cross-contamination
after flooding.
The guidance represents the Agency's current thinking on the safety
of flood-affected food crops for human consumption. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received
[[Page 65735]]
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm
or https://www.regulations.gov. Always access an FDA guidance document
by using FDA's Web site listed previously to find the most current
version of the guidance.
Dated: October 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-27382 Filed 10-21-11; 8:45 am]
BILLING CODE 4160-01-P
