80 FR 70236 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 219 (November 13, 2015)

Page Range		70236-70237
FR Document		2015-28789

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 80 Issue 219 (Friday, November 13, 2015)

[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)]
[Notices]
[Pages 70236-70237]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-28789]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0922]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-Based Preventive Controls for Food for 
Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food 
for Animals'' 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, [email protected].

SUPPLEMENTARY INFORMATION: On September 17, 2015, the Agency submitted 
a proposed collection of information entitled ``Current Good 
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Food for Animals'' 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 0910-0789. 
The approval expires on October 31, 2018. A copy of the supporting 
statement for this

[[Page 70237]]

information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: November 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28789 Filed 11-12-15; 8:45 am]
 BILLING CODE 4164-01-P

70236 Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices

announced the availability of a draft www.fda.gov/Drugs/Guidance 1. De Pauw, B., T. J. Walsh, J. P. Donnelly,
guidance entitled ‘‘Draft Guidance on ComplianceRegulatoryInformation/ et al., ‘‘Revised Definitions of Invasive
Qualification of Biomarker— Guidances/default.htm. The current Fungal Disease from European Organization
guidance is an attachment to that final for Research and Treatment of Cancer/
Galactomannan in studies of Treatments
Invasive Fungal Infections Cooperative
of Invasive Aspergillosis.’’ The Agency guidance. Group and the National Institute of Allergy
received one comment during the public CDER has initiated this formal and Infectious Diseases Mycoses Study
comment period which was supportive qualification process to work with Group (EORTC/MSG) Consensus Group,’’
of the qualification of this biomarker. developers of these biomarker DDTs to Clinical Infectious Diseases, 46:12, pp. 1813–
This guidance finalizes the draft guide them as they refine and evaluate 1821, 2008.
guidance issued in October 2014. DDTs for use in the regulatory context. Dated: November 4, 2015.
This guidance provides qualification Once qualified, biomarker DDTs will be Leslie Kux,
recommendations for the use of publicly available for use in any drug
Associate Commissioner for Policy.
Galactomannan detection in serum and/ development program for the qualified
or BAL fluid as the sole microbiological [FR Doc. 2015–28804 Filed 11–12–15; 8:45 am]
COU. As described in the January 2014
criterion to classify patients with guidance, biomarker DDTs should be BILLING CODE 4164–01–P
hematologic malignancies and developed and reviewed using this
recipients of allogeneic hematopoietic process. For more information on FDA’s
stem cell transplants and who also have DDTs Qualification Programs, refer to DEPARTMENT OF HEALTH AND
radiologic evidence suggestive of the following Web page: http:// HUMAN SERVICES
invasive fungal infection (Ref. 1) as www.fda.gov/Drugs/Development Food and Drug Administration
having probable IA for enrollment in ApprovalProcess/DrugDevelopment
clinical trials. ToolsQualificationProgram/default.htm. [Docket No. FDA–2011–N–0922]
Specifically, this guidance provides This guidance is being issued
the COU for which this biomarker is consistent with FDA’s good guidance Agency Information Collection
qualified through the CDER Biomarker practices regulation (21 CFR 10.115). Activities; Announcement of Office of
Qualification Program. Qualification of The guidance represents the Agency’s Management and Budget Approval;
this biomarker for this specific COU current thinking for the use of Current Good Manufacturing Practice,
represents the conclusion that Galactomannan detection in serum and/ Hazard Analysis, and Risk-Based
analytically valid measurements of the or BAL fluid as the sole microbiological Preventive Controls for Food for
biomarker can be relied on to have a criterion to classify patients as having Animals
specific use and interpretable meaning. probable IA for enrollment in clinical AGENCY: Food and Drug Administration,
This biomarker can be used by drug trials. It does not establish any rights for HHS.
developers for the qualified COU in any person and is not binding on FDA
submission of INDs, NDAs, and BLAs ACTION: Notice.
or the public. You can use an alternative
without the relevant CDER review group approach if it satisfies the requirements SUMMARY: The Food and Drug
reconsidering and reconfirming the of the applicable statutes and Administration (FDA) is announcing
suitability of the biomarker. regulations. that a collection of information entitled
‘‘Qualification’’ means that the use of ‘‘Current Good Manufacturing Practice,
this biomarker in the specific COU is II. The Paperwork Reduction Act of
Hazard Analysis, and Risk-Based
not limited to a single, specific drug 1995
Preventive Controls for Food for
development program. Making the This guidance refers to previously Animals’’ has been approved by the
qualification recommendations widely approved collections of information Office of Management and Budget
known and available for use by drug found in FDA regulations. These (OMB) under the Paperwork Reduction
developers will contribute to drug collections of information are subject to Act of 1995.
innovation, thus supporting public review by the Office of Management and FOR FURTHER INFORMATION CONTACT: FDA
health. Budget (OMB) under the Paperwork
Innovative and improved Drug PRA Staff, Office of Operations, Food
Reduction Act of 1995 (44 U.S.C. 3501– and Drug Administration, 8455
Development Tools (DDTs) can help 3520). The collections of information in
streamline the drug development Colesville Rd., COLE–14526, Silver
21 CFR 312.30, 21 CFR 314.50(d)(5), and Spring, MD 20993–0002, PRAStaff@
process, improve the chances for 21 CFR 314.126(b)(6) have been
clinical trial success, and yield more fda.hhs.gov.
approved under OMB control numbers
information about a treatment and/or SUPPLEMENTARY INFORMATION: On
0910–0001 and 0910–0014.
disease. DDTs include, but are not September 17, 2015, the Agency
limited to, biomarkers, clinical outcome III. Electronic Access submitted a proposed collection of
assessments, and animal models. Refer Persons with access to the Internet information entitled ‘‘Current Good
to DDTs Qualification Programs at may obtain the document at either Manufacturing Practice, Hazard
http://www.fda.gov/Drugs/Development http://www.fda.gov/Drugs/Guidance Analysis, and Risk-Based Preventive
ApprovalProcess/DrugDevelopment ComplianceRegulatoryInformation/ Controls for Food for Animals’’ to OMB
ToolsQualificationProgram/default.htm Guidances/default.htm or http:// for review and clearance under 44
for additional information. www.regulations.gov. U.S.C. 3507. An Agency may not
In the Federal Register of January 7, conduct or sponsor, and a person is not
2014 (79 FR 831), FDA announced the IV. Reference required to respond to, a collection of
jstallworth on DSK7TPTVN1PROD with NOTICES

availability of a final guidance for The following reference is on display information unless it displays a
industry entitled ‘‘Qualification Process in the Division of Dockets Management currently valid OMB control number.
for Drug Development Tools’’ that (see ADDRESSES) and is available for OMB has now approved the information
described the process that would be viewing by interested persons between collection and has assigned OMB
used to qualify DDTs and to make new 9 a.m. and 4 p.m., Monday through control number 0910–0789. The
DDT qualification recommendations Friday; it is also available electronically approval expires on October 31, 2018. A
available on FDA’s Web site at http:// at http://www.regulations.gov. copy of the supporting statement for this

VerDate Sep<11>2014 15:03 Nov 12, 2015 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\13NON1.SGM 13NON1

Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 70237

information collection is available on OMB recommends that written supplement marketed in the United
the Internet at http://www.reginfo.gov/ comments be faxed to the Office of States to include a domestic address or
public/do/PRAMain. Information and Regulatory Affairs, domestic telephone number through
Dated: November 5, 2015. OMB, Attn: FDA Desk Officer, FAX: which the product’s manufacturer,
Leslie Kux, 202–395–7285, or emailed to oira_ packer or distributor may receive a
Associate Commissioner for Policy.
submission@omb.eop.gov. All report of a serious adverse event
comments should be identified with the associated with the dietary supplement.
[FR Doc. 2015–28789 Filed 11–12–15; 8:45 am]
OMB control number 0910–0642. Also
BILLING CODE 4164–01–P In the Federal Register of September
include the FDA docket number found
1, 2009 (74 FR 45221), we announced
in brackets in the heading of this
document. the availability of a guidance document
DEPARTMENT OF HEALTH AND entitled, ‘‘Guidance for Industry:
HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: FDA Questions and Answers Regarding the
PRA Staff, Office of Operations, Food Labeling of Dietary Supplements as
Food and Drug Administration and Drug Administration, 8455 Required by the Dietary Supplement
[Docket No. FDA–2012–N–0564] Colesville Rd., COLE–14526, Silver and Nonprescription Drug Consumer
Spring, MD 20993–0002, PRAStaff@ Protection Act.’’ The guidance
Agency Information Collection fda.hhs.gov. document contains questions and
Activities; Submission for Office of answers related to the labeling
SUPPLEMENTARY INFORMATION: In
Management and Budget Review; requirements in section 403(y) of the
compliance with 44 U.S.C. 3507, FDA
Comment Request; Dietary FD&C Act and provides guidance to
has submitted the following proposed
Supplement Labeling Requirements
collection of information to OMB for industry on the use of an explanatory
and Recommendations Under the
review and clearance. statement before the domestic address
Dietary Supplement and
or telephone number. The guidance
Nonprescription Drug Consumer Dietary Supplement Labeling
Protection Act document provides our interpretation of
Requirements and Recommendations
the labeling requirements for section
Under the Dietary Supplement and
AGENCY: Food and Drug Administration, 403(y) of the FD&C Act and our views
Nonprescription Drug Consumer
HHS. on the information that should be
Protection Act—(OMB Control Number
ACTION: Notice. 0910–0642)–Extension included on the label. We believe that
the guidance will enable persons to
SUMMARY: The Food and Drug In 2006, the Dietary Supplement and meet the criteria for labeling that are
Administration (FDA) is announcing Nonprescription Drug Consumer established in section 403(y) of the
that a proposed collection of Protection Act (the DSNDCPA) amended FD&C Act.
information has been submitted to the the Federal Food, Drug, and Cosmetic
Office of Management and Budget In the Federal Register of August 24,
Act (the FD&C Act) with respect to
(OMB) for review and clearance under serious adverse event reporting for 2015 (80 FR 51278), FDA published a
the Paperwork Reduction Act of 1995. dietary supplements and 60-day notice requesting public
DATES: Fax written comments on the nonprescription drugs marketed without comment on the proposed collection of
collection of information by December an approved application. The information. No comments were
14, 2015. DSNDCPA also amended the FD&C Act received.
ADDRESSES: To ensure that comments on to add section 403(y) (21 U.S.C. 343(y)), We estimate the burden of this
the information collection are received, which requires the label of a dietary collection of information as follows:

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Activity burden per Total hours
respondents per disclosures disclosure
respondent

Domestic address or phone number labeling requirement
(21 U.S.C. 343(y)) ............................................................ 1,700 3.27 5,560 0.2 1,112
FDA recommendation for label statement explaining pur-
pose of domestic address or phone number ................... 1,700 3.27 5,560 0.2 1,112

Total .............................................................................. ........................ ........................ ........................ ........................ 2,224
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The labeling requirements of section accordingly. Thus our current burden sales are greater than zero to be 55,600.
403(y) of the FD&C Act became effective estimate for this information collection Assuming that the flow of new products
on December 22, 2007, although we applies only to new product labels. is 10 percent per year, then each year
In row 1 of Table 1 we estimate the
jstallworth on DSK7TPTVN1PROD with NOTICES

exercised enforcement discretion until approximately 5,560 new dietary
September 30, 2010, to enable all firms total annual hourly burden necessary to supplement products are projected to
to meet the labeling requirements for comply with the requirement under enter the market. Estimating that there
dietary supplements. At this time, section 403(y) of the FD&C Act (21 are 1,700 dietary supplement
therefore, we expect that all labels U.S.C. 343(y)) to be 1,112 hours. Using manufacturers, re-packagers, re-labelers,
required to include the domestic historical A.C. Nielson Sales Scanner and holders of dietary supplements
address or telephone number issued in Data, we estimate the number of dietary subject to the information collection
section 403(y) have been revised supplement SKUs for which product requirement (using the figure 1,460 as

VerDate Sep<11>2014 17:57 Nov 12, 2015 Jkt 238001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\13NON1.SGM 13NON1

Document Created: 2018-03-01 11:23:06
Document Modified: 2018-03-01 11:23:06

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 70236

80 FR 70236 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 219 (November 13, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration