80 FR 46587 - Use of Nanomaterials in Food for Animals; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 150 (August 5, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 150 (August 5, 2015)
| Page Range | 46587-46588 | |
| FR Document | 2015-19179 |
[Federal Register Volume 80, Number 150 (Wednesday, August 5, 2015)] [Notices] [Pages 46587-46588] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-19179] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1009] Use of Nanomaterials in Food for Animals; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of guidance for industry #220 entitled ``Use of Nanomaterials in Food for Animals.'' The guidance describes FDA's current thinking regarding the use of nanomaterials or the application of nanotechnology in food for animals. It is intended to assist industry and other stakeholders in identifying potential issues related to the safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology. 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 Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 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 http://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: Dragan Momcilovic, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6856, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 27, 2014 (79 FR 36530), FDA published the notice of availability for a draft guidance #220 entitled ``Use of Nanomaterials in Food for Animals'' giving interested persons until September 10, 2014, to comment on the draft guidance. FDA received several comments on the draft guidance and those comments were [[Page 46588]] considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance dated June 2014. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on the use of nanomaterials in food for animals. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 This 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 571.1 and 21 CFR 571.6 have been approved under 0910-0546. IV. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of 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, and will be posted to the docket at http://www.regulations.gov. V. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov. Dated: July 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-19179 Filed 8-4-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 150 / Wednesday, August 5, 2015 / Notices 46587
the information collection requirements Department of Health and Human DEPARTMENT OF HEALTH AND
relating to the Small Business Services (HHS) to establish a Small HUMAN SERVICES
Innovation Research Program (SBIR)— Business Innovation Research (SBIR)
Phase II. program by reserving a statutory Food and Drug Administration
DATES: Submit written or electronic percentage of their extramural research [Docket No. FDA–2013–D–1009]
comments on the collection of and development budgets to be awarded
information by October 5, 2015. to small business concerns for research Use of Nanomaterials in Food for
ADDRESSES: Submit electronic or research and development (R/R&D) Animals; Guidance for Industry;
comments on the collection of through a uniform, highly competitive, Availability
information to: Brian.Bard@acl.hhs.gov. three-phase process each fiscal year. AGENCY: Food and Drug Administration,
FOR FURTHER INFORMATION CONTACT: The Act further requires the Small HHS.
Brian Bard at 202–254–7345 or Business Administration (SBA) to issue
Brian.Bard@acl.hhs.gov. ACTION: Notice.
policy directives for the general conduct
SUPPLEMENTARY INFORMATION: Under the of the SBIR programs within the Federal SUMMARY: The Food and Drug
PRA (44 U.S.C. 3501–3520), Federal Government. The purpose of this Administration (FDA) is announcing the
agencies must obtain approval from the program is to stimulate technological availability of guidance for industry
Office of Management and Budget Innovation in the private sector, #220 entitled ‘‘Use of Nanomaterials in
(OMB) for each collection of strengthen the role of small business in Food for Animals.’’ The guidance
information they conduct or sponsor. meeting Federal research and research describes FDA’s current thinking
‘‘Collection of information’’ is defined and development needs, increase the regarding the use of nanomaterials or
in 44 U.S.C. 3502(3) and 5 CFR the application of nanotechnology in
commercial application of Department
1320.3(c) and includes agency request food for animals. It is intended to assist
of Education (ED) supported research
or requirements that members of the industry and other stakeholders in
public submit reports, keep records, or results, and improve the return on
investment from Federally-funded identifying potential issues related to
provide information to a third party. the safety or regulatory status of food for
Section 3506(c)(2)(A) of the PRA (44 research for economic and social
animals containing nanomaterials or
U.S.C. 3506(c)(2)(A)) requires Federal benefits to the Nation.
otherwise involving the application of
agencies to provide a 60-day notice in Awards are made on the basis of nanotechnology.
the Federal Register concerning each competitively reviewed applications.
proposed collection of information, DATES: Submit either electronic or
The Department is requesting approval
including each proposed extension of an written comments on Agency guidances
of this grant application package for the
existing collection of information, at any time.
information used to apply for new
before submitting the collection to OMB ADDRESSES: Submit written requests for
grants under the Small Business
for approval. To comply with this single copies of the guidance to the
Innovation Research (SBIR) Phase II
requirement, ACL/NIDILRR is Policy and Regulations Staff (HFV–6),
program. Phase I is intended to
publishing notice of the proposed Center for Veterinary Medicine, Food
determine, insofar as possible, the and Drug Administration, 7519 Standish
collection of information set forth in scientific or technical merit and
this document. With respect to the Pl., Rockville, MD 20855. Send one self-
feasibility of ideas. Phase II is intended addressed adhesive label to assist that
following collection of information,
to expand on the results of and to office in processing your requests. See
ACL/NIDILRR invites comments on: (1)
further pursue the development of a the SUPPLEMENTARY INFORMATION section
Whether the proposed collection of
information is necessary for the proper Phase I project. Phase II is the principal for electronic access to the guidance
performance of ACL/NIDILRR’s research and research and development document.
functions, including whether the effort. It requires a more comprehensive Submit electronic comments on the
information will have practical utility; application, outlining the effort in detail guidance to http://www.regulations.gov.
(2) the accuracy of ACL/NIDILRR’s including the commercial potential. Submit written comments to the
estimate of the burden of the proposed Phase II applications must be Phase I Division of Dockets Management (HFA–
collection of information, including the grantees with findings that appear 305), Food and Drug Administration,
validity of the methodology and sufficiently promising as a result of 5630 Fishers Lane, Rm. 1061, Rockville,
assumptions used; (3) ways to enhance Phase I. Applications are evaluated MD 20852.
the quality, utility, and clarity of the based on published criteria by panels of FOR FURTHER INFORMATION CONTACT:
information to be collected; and (4) experts. Dragan Momcilovic, Center for
ways to minimize the burden of the ACL/NIDILRR estimates the burden of Veterinary Medicine (HFV–226), Food
collection of information on this collection of information as 240 and Drug Administration, 7519 Standish
respondents, including through the use Pl., Rockville, MD 20855, 240–453–
hours for project staff, 320 for reviewers,
of automated collection techniques 6856, dragan.momcilovic@fda.hhs.gov.
and 1,080 hours for individuals. Total
when appropriate, and other forms of SUPPLEMENTARY INFORMATION:
burden is 1,640 hours per year.
information technology. ACL/NIDILRR
proposes to use this set of data Dated: July 31, 2015. I. Background
collection tools to be used as a grant In the Federal Register of June 27,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Kathy Greenlee,
application package for the information Administrator and Assistant Secretary for 2014 (79 FR 36530), FDA published the
used to apply for new grants under the Aging. notice of availability for a draft guidance
SBIR program (Phase II). [FR Doc. 2015–19237 Filed 8–4–15; 8:45 am] #220 entitled ‘‘Use of Nanomaterials in
Public Law 106–554, the ‘‘Small Food for Animals’’ giving interested
BILLING CODE 4154–01–P
Business Reauthorization Act of 2000, persons until September 10, 2014, to
H.R. 5567’’ (the ‘‘Act’’) was enacted on comment on the draft guidance. FDA
December 21, 2000. The Act requires received several comments on the draft
certain agencies, including the guidance and those comments were
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![46588 Federal Register / Vol. 80, No. 150 / Wednesday, August 5, 2015 / Notices
considered as the guidance was DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION:
finalized. The guidance announced in HUMAN SERVICES I. Background
this notice finalizes the draft guidance
dated June 2014. Food and Drug Administration FDA is announcing the availability of
a guidance for industry entitled ‘‘Over-
II. Significance of Guidance [Docket No. FDA–2014–D–1473]
the-Counter Pediatric Oral Liquid Drug
Over-the-Counter Pediatric Oral Liquid Products Containing Acetaminophen.’’
This level 1 guidance is being issued Acetaminophen is marketed in many
consistent with FDA’s good guidance Drug Products Containing
Acetaminophen; Guidance for OTC drug products as a pain reliever
practices regulation (21 CFR 10.115). and fever reducer. Most OTC
The guidance represents the current Industry; Availability
acetaminophen products are marketed
thinking of the Food and Drug AGENCY: Food and Drug Administration, under FDA’s ongoing rulemaking to
Administration (FDA or Agency) on the HHS. establish a final monograph for OTC
use of nanomaterials in food for ACTION: Notice. internal analgesic, antipyretic, and
animals. It does not establish any rights antirheumatic (IAAA) drug products.
for any person and is not binding on SUMMARY: The Food and Drug These products must conform to the
FDA or the public. You can use an Administration (FDA or the Agency) is conditions described in FDA’s Tentative
alternative approach if it satisfies the announcing the availability of a Final Monograph for Internal Analgesic,
requirements of the applicable statutes guidance for industry entitled ‘‘Over- Antipyretic, and Antirheumatic Drug
and regulations. the-Counter Pediatric Oral Liquid Drug Products for Over-the-Counter (OTC)
Products Containing Acetaminophen.’’ Human Use (the IAAA TFM) 1 and
III. Paperwork Reduction Act of 1995 The guidance is intended to help drug FDA’s general regulations for OTC drug
manufacturers, packagers, and labelers marketing (21 CFR 330.1) and labeling
This guidance refers to previously minimize the risk to consumers of (21 CFR 330.10 and part 201). They also
approved collections of information acetaminophen-related liver damage must be labeled with acetaminophen-
found in FDA regulations. These associated with the use of related warnings and other information
collections of information are subject to nonprescription, also known as over- as specified in 21 CFR 201.326.
review by the Office of Management and the-counter or OTC, pediatric oral liquid However, OTC pediatric oral liquid drug
Budget (OMB) under the Paperwork acetaminophen drug products. This products containing acetaminophen
Reduction Act of 1995 (44 U.S.C. 3501– guidance provides recommendations have been associated with overdoses
3520). The collections of information in regarding acetaminophen concentration, due to medication errors that resulted in
21 CFR 571.1 and 21 CFR 571.6 have container labels, carton labeling, and serious adverse events, including severe
been approved under 0910–0546. packaging of such products, as well as liver damage and death. In particular,
for any associated delivery devices. there have been reports of overdose
IV. Comments FDA’s recommendations are designed to attributed to confusion between
Interested persons may submit either encourage safer use of these products by concentrated acetaminophen drops (80
electronic comments regarding this minimizing the potential for milligrams (mg)/0.8 milliliters (mL) and
document to http://www.regulations.gov acetaminophen overdosing due to 80 mg/mL) and acetaminophen oral
or written comments to the Division of medication errors or accidental liquid (160 mg/5 mL).
ingestion. This guidance document is part of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of DATES: Submit either electronic or FDA’s ongoing initiative to reduce the
written comments on Agency guidances risk of acetaminophen-related liver
comments. Identify comments with the
at any time. injury associated with all OTC and
docket number found in brackets in the
ADDRESSES: Submit written requests for
prescription acetaminophen-containing
heading of this document. Received
single copies of the guidance to the products. As part of that initiative, in
comments may be seen in the Division June 2009, three FDA committees, the
of Dockets Management between 9 a.m. Division of Drug Information, Center for
Drug Evaluation and Research, Food Drug Safety and Risk Management
and 4 p.m., Monday through Friday, and Advisory Committee, the
will be posted to the docket at http:// and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, Nonprescription Drugs Advisory
www.regulations.gov. Committee, and the Anesthetic and Life
4th Floor, Silver Spring, MD 20993–
V. Electronic Access 0002. Send one self-addressed adhesive Support Drugs Advisory Committee,
label to assist that office in processing met jointly to consider a range of risk
Persons with access to the Internet your requests. See the SUPPLEMENTARY reduction measures. Among other
may obtain the guidance at either INFORMATION section for electronic
measures, these Advisory Committees
http://www.fda.gov/AnimalVeterinary/ access to the guidance document. recommended moving to a single,
GuidanceComplianceEnforcement/ Submit electronic comments on the standardized acetaminophen
GuidanceforIndustry/default.htm or guidance to http://www.regulations.gov. concentration for OTC pediatric oral
http://www.regulations.gov. Submit written comments to the liquid drug products because the
Division of Dockets Management (HFA– availability of multiple concentrations
Dated: July 30, 2015. causes confusion and errors among both
305), Food and Drug Administration,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Leslie Kux, consumers and health care
5630 Fishers Lane, Rm. 1061, Rockville,
Associate Commissioner for Policy.
MD 20852. 1 ‘‘Internal Analgesic, Antipyretic, and
[FR Doc. 2015–19179 Filed 8–4–15; 8:45 am]
FOR FURTHER INFORMATION CONTACT: Antirheumatic Drug Products for Over-the-Counter
BILLING CODE 4164–01–P Alice Tu, Center for Drug Evaluation Human Use; Tentative Final Monograph,’’ 53 FR
and Research, Food and Drug 46204 (November 16, 1988). Available at http://
www.fda.gov/downloads/Drugs/Development
Administration, 10903 New Hampshire ApprovalProcess/DevelopmentResources/Over-the-
Ave., Bldg. 22, Rm. 4325, Silver Spring, CounterOTCDrugs/StatusofOTCRulemakings/
MD 20993–0002, 301–796–7586. UCM078460.pdf.
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Document Created: 2018-02-23 10:53:27
Document Modified: 2018-02-23 10:53:27
| 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. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Dragan Momcilovic, Center for Veterinary Medicine (HFV-226), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-453-6856, [email protected] | |
| FR Citation | 80 FR 46587 |
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