80 FR 73194 - Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 226 (November 24, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 226 (November 24, 2015)
| Page Range | 73194-73198 | |
| FR Document | 2015-29903 |
[Federal Register Volume 80, Number 226 (Tuesday, November 24, 2015)] [Notices] [Pages 73194-73198] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-29903] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2000-D-0075] Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Voluntary Labeling Indicating Whether [[Page 73195]] Foods Have or Have Not Been Derived from Genetically Engineered Plants.'' The guidance is intended to help food manufacturers that wish to voluntarily label their plant-derived food products or ingredients (for humans or for animals) as having been made with or without bioengineering. DATES: Submit either electronic or written comments on the guidance at any time. Fax written comments on the collection of information by December 24, 2015. ADDRESSES: To ensure that comments on the information collection are received, the Office of Management and Budget (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-New and title ``Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants.'' Also include the FDA docket number found in brackets in the heading of this document. You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2000-D-0075 for ``Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of this guidance to the Office of Nutrition, Labeling, and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Regarding human food issues: Andrea Krause, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371. Regarding animal food issues: Kathleen Jones, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-7077. Regarding the information collection: 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: I. Background Section 403 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343) generally governs the labeling of foods. Under section 403(a)(1) of the FD&C Act, a food is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act (21 U.S.C. 321(n)) provides that labeling is misleading if, among other things, it fails to reveal facts that are material in light of representations made or suggested in the labeling, or material with respect to consequences that may result from the use of the food to which the labeling relates under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual. In the Federal Register of May 29, 1992 (57 FR 22984), we published a ``Statement of Policy: Foods Derived from New Plant Varieties'' (1992 Policy). The 1992 Policy applies to foods for humans and animals that are developed from new plant varieties, including varieties that are developed using recombinant deoxyribonucleic acid (rDNA) technology. This technology has long been referred to as ``rDNA technology,'' ``genetic [[Page 73196]] engineering,'' or ``bioengineering,'' and more recently, as ``modern biotechnology.'' In the 1992 Policy, we addressed, among other things, the labeling of foods derived from new plant varieties, including plants developed by bioengineering. In the 1992 Policy, we explained that we were not establishing special labeling requirements for foods from bioengineered plants as a class of foods because we did not find any basis for concluding that foods from bioengineered plants, as a class, differ from other foods in any meaningful or uniform way, or that foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding. In the Federal Register of January 18, 2001 (66 FR 4839), we announced the availability of a draft guidance for industry entitled ``Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering.'' We received more than 155,000 comments on the draft guidance. Most comments were submitted by consumers. Other comments represented the views of advocacy groups, trade organizations, organic grocers/food co-ops, private sector business, farming/farm bureaus, food manufacturers, crop developers, local governments, and academic researchers. We have considered the comments and revised the guidance as appropriate. We understand that consumers may want information about whether or not a food is developed through genetic engineering. Thus, we are providing guidance on voluntary labeling that will help manufacturers that would like to provide consumers with additional information about the foods they consume. We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. 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. In addition, this guidance does not preempt State food labeling requirements that are consistent with the Federal requirements described in the guidance and that are not otherwise expressly preempted by the FD&C Act. II. Paperwork Reduction Act of 1995 This final guidance contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). Under the PRA, Federal Agencies must obtain approval from OMB for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, in the Federal Register of January 18, 2001, we gave interested persons 60 days to comment on the information collection provisions in the draft guidance (66 FR 4839 at 4840). After publishing the 60-day notice requesting public comment, section 3507 of the PRA (44 U.S.C. 3507) requires Federal Agencies to submit the proposed collection to OMB for review and clearance. In compliance with 44 U.S.C. 3507, we have submitted the following proposed collection of information to OMB for review and clearance. FDA is issuing this final guidance subject to OMB approval of the collection of information. If the collection is approved, FDA will publish a notice in the Federal Register concerning OMB approval and providing an OMB control number. Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants OMB Control Number 0910-New As noted, in the Federal Register of January 18, 2001, we announced the availability of the draft guidance document and requested public comment on the information collection provisions. Subsequently, we published a document in the Federal Register of October 31, 2003 (68 FR 62086), informing interested parties that the proposed collection of information had been submitted to the OMB for review and clearance under the PRA. However, we determined that the request for comments was issued prematurely. Thus, we withdrew the notice on November 21, 2003 (68 FR 65717). We are now reissuing the request for comments and submitting the proposed collection of information to OMB. The guidance entitled ``Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants'' is intended to assist manufacturers that wish to voluntarily label their foods (human or animal) as being made with or without genetic engineering or the use of genetically engineered ingredients, to ensure that such labeling is truthful and not misleading. The information that the manufacturers will collect is documentation of handling practices so that they can truthfully label their products to indicate, if they so choose, whether the food has or has not been developed using genetic engineering. In general, we anticipate that manufacturers claiming that a product is not developed using genetically engineered material would substantiate the claim. We suggest that manufacturers document practices and procedures to substantiate a claim that a food was not developed using genetic engineering. Examples of documentation that we anticipate will demonstrate practices and procedures are recordkeeping, and certifications or affidavits from farmers, processors, and others in the food production and distribution chain. We are neither suggesting that firms maintain a certain set list of documents nor are we suggesting that anything less or different would likely be considered unacceptable. Rather, we are leaving it to each firm's judgment to maintain appropriate documentation to demonstrate that the food was produced using traditional methods. Description of Respondents: The respondents to the proposed collection of information are manufacturers of foods that were or were not derived from genetically engineered plants who wish to voluntarily label their food products. As noted, in the Federal Register of January 18, 2001, we published a 60-day notice requesting public comment on the proposed collection of information. We received more than 155,000 comments, each containing one or more issues. The following is a discussion of the comments we received on the information collection and our response to those comments. (Comment 1) Most comments agreed that labeling food products as genetically engineered or non-genetically engineered would result in costs due to segregation, testing, or third-party validation, in addition to label changes. However, some comments said the producers that choose to label their products as non-genetically engineered and the consumers that choose to purchase these products should incur these costs. Other comments said that these costs should be borne by the growers, manufacturers, processors, and [[Page 73197]] marketers of genetically engineered foods. (Response) We disagree that it would be necessary to incur costs due to segregation, testing, or third-party validation to substantiate a claim that a food was not developed using genetic engineering. We also note that the question of who should bear the paperwork burden is not within the scope of the guidance. (Comment 2) One comment stated that we underestimated the number of small firms that will choose to label their product as not genetically engineered, but will not attempt to make an organic claim. (Response) We disagree that we underestimated the number of respondents in the 2001 60-day Federal Register notice. The comment did not offer any evidence to substantiate this claim or give an estimate of how many small firms will choose to make a non-genetically engineered claim. We based our estimate of the number of firms that would label their products with a genetically engineered claim on the number of products making an organic claim and the number of products that were not currently making an organic claim on their label, but were making a statement about genetic engineering on their Web site, through a press release, or other venue when the 2001 60-day notice was published. We have, however, updated in this notice the estimated number of recordkeepers to reflect new information on the number of foods that are labeled as not genetically engineered. (Comment 3) Numerous comments pointed out that mandatory labeling would have high costs for additional activities such as segregation, testing, labeling, quality control, and certification. One comment estimated that these costs could be as high as 6 to 17 percent of the farmgate price. (Response) The paperwork reduction analysis only estimates the paperwork burden associated with voluntary labeling. The estimates related to mandatory labeling are outside the scope of the guidance, and we have not included them in the analysis. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Activity Number of records per Total annual per Total hours recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- Recordkeeping per the Guidance.................................... 85 4 340 1 340 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. We have updated the number of recordkeepers and respondents to reflect new information on the number of food products that are labeled using the terms ``biotechnology'' and ``GMO'' (genetically modified organism) since the 2001 issuance of the 60-day notice and draft guidance. We estimate a recordkeeping burden, to retain paperwork to substantiate that the food or ingredient is produced without genetic engineering, only for products that are not also already labeled using the term ``organic.'' We did not include products that are labeled ``organic'' in the estimated annual recordkeeping burden because, according to a final rule in the Federal Register of December 21, 2000 (65 FR 80548), issued by the Agriculture Marketing Service of the U.S. Department of Agriculture, a food labeled as ``organic'' would not be permitted to contain genetically engineered materials. Thus, there is no additional paperwork burden to substantiate a claim that a product is not developed using genetic engineering for these certified organic products. We based our revised estimates of the recordkeeping burden (table 1 of this document) on data from Labelbase by FoodEssentials. Labelbase is a custom online system for accessing a consumer packaged goods product data; the database contains more than 250,000 product labels that can be searched by keyword, ingredient, nutrient, allergen, label claim, or food additive, for example. Using this database, we have identified 540 food manufacturers who produce 2,160 products with the term ``bioengineered'' or ``GMO'' on their labels; this estimate includes manufacturers of human food and pet food. In addition, the National Center for Appropriate Technology's National Sustainable Agriculture Information Center maintains on its Web site a list of Organic Livestock Feed Suppliers. Using this list, we have identified 54 livestock feed suppliers that would be likely to include a statement about bioengineering on the label of their products and thus would have documentation to substantiate their claim. Of the 2,160 human food and pet food products that we have identified as using the term ``bioengineered'' or ``GMO'' on their labels (presumably used in a context to designate foods that are not bioengineered), 1,140 of these products (285 manufacturers) also use the term ``organic'' on the label; 1,020 products do not use the term ``organic'' on the label (2,160 - 1,140 = 1,020 products not organics; 540-285 = 255 manufacturers of not organic products). In addition, the 54 livestock feed suppliers are also organic producers, thus the 216 products attributed to these manufacturers already are considered to be labeled ``organic.'' Thus, there are 1,020 products made by 255 human food and pet food manufacturers that would need to substantiate that their product or ingredient was not genetically engineered. We estimate that the burden of maintaining the documentation is a one-time burden; the document to substantiate that the product or ingredient was produced without genetic engineering only needs to be generated once and then kept on file. To annualize this one-time burden, we divide by 3 because paperwork burden collections are approved on a 3-year cycle (255/3 = 85). Thus, we estimate in table 1 that, on average, 85 manufacturers annually will collect and keep information that substantiates their label claim for four products (1,020 products/3 = 340 products/85 manufacturers = 4 products per manufacturer). We estimate this one-time recordkeeping burden to be 1 hour per product that makes use of a labeling claim which results in a burden of 1 hour for a total annualized recordkeeping burden of 340 hours (85 manufacturers x 4 records per manufacturer x 1 hour per record). In the 2001 notice, we estimated $53,040 as ``operating and maintenance costs'' associated with this recordkeeping burden. These costs were reported in error and have been removed from table 1. We estimate no capital costs or operating and maintenance costs associated with this recordkeeping burden. [[Page 73198]] We do not estimate any reporting burden or third party disclosure burden associated with this information collection. Manufacturers who want to make use of this voluntary labeling claim option are considered to be those that already have such wording on their products' labels. We do not expect that this guidance will cause labels already in the marketplace to need to be re-worded. III. Electronic Access Persons with access to the Internet may obtain the guidance at http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance. Dated: November 19, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-29903 Filed 11-23-15; 8:45 am] BILLING CODE 4164-01-P
![73194 Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Notices
FOR FURTHER INFORMATION CONTACT: characteristics.1 (Elsewhere in this issue containing or not containing products
Regarding human food issues: Andrea of the Federal Register, we are from GE Atlantic salmon. FDA’s main
Krause, Center for Food Safety and announcing the availability of a final concern within the context of this
Applied Nutrition (HFS–820), Food and guidance entitled ‘‘Guidance for guidance is that any voluntary labeling
Drug Administration, 5100 Paint Branch Industry: Voluntary Labeling Indicating be truthful and not misleading.
Pkwy., College Park, MD 20740, 240– Whether Foods Have or Have Not Been
III. Paperwork Reduction Act of 1995
402–2371. Regarding animal food Derived from Genetically Engineered
issues: Kathleen Jones, Center for Plants.’’) Changes to the name of the Under the Paperwork Reduction Act
Veterinary Medicine (HFV–220), Food product or other additional labeling are of 1995 (the PRA) (44 U.S.C. 3501–
and Drug Administration, 7519 Standish not required if the resulting food is not 3520), Federal Agencies must obtain
Pl., Rockville, MD 20855, 240–402– materially different from its non- approval from the Office of Management
7077. genetically engineered counterpart. and Budget (OMB) for each collection of
In the process of deciding whether or information they conduct or sponsor.
SUPPLEMENTARY INFORMATION: not to require additional labeling of This draft guidance contains proposed
I. Background AquAdvantage Salmon, FDA considered collections of information. ‘‘Collection
whether food from AquAdvantage of information’’ is defined in 44 U.S.C.
We are announcing the availability of Salmon is materially different from non- 3502(3) and 5 CFR 1320.3(c) and
a draft guidance for industry entitled GE, farm-raised Atlantic salmon. As part includes Agency requests or
‘‘Voluntary Labeling Indicating Whether of our evaluation, we assessed data and requirements that members of the public
Food Has or Has Not Been Derived From information submitted in response to submit reports, keep records, or provide
Genetically Engineered Atlantic our August 26, 2010, Federal Register information to a third party. Section
Salmon.’’ We are issuing the draft document entitled ‘‘Food Labeling; 3506(c)(2)(A) of the PRA (44 U.S.C.
guidance consistent with our good Labeling of Food Made From 3506(c)(2)(A)) requires Federal Agencies
guidance practices regulation (21 CFR AquAdvantage Salmon; Public Hearing; to publish a 60-day notice in the
10.115). The draft guidance, when Request for Comments’’ (75 FR 52602), Federal Register soliciting public
finalized, will represent the current as well as data and information comment on each proposed collection of
thinking of FDA on this topic. It does submitted by the sponsor. information before submitting the
not establish any rights for any person Based on our review of the sponsor’s collection to OMB for approval. To
and is not binding on FDA or the public. data and information, and other comply with this requirement, FDA will
You can use an alternate approach if it information available to the Agency publish a 60-day notice on the proposed
satisfies the requirements of the (e.g., FDA’s laboratory analyses collections of information in this draft
applicable statutes and regulations. establishing that AquAdvantage Salmon guidance in a future issue of the Federal
On November 19, 2015, FDA meets the criteria for Atlantic salmon Register.
approved a new animal drug application established for the Regulatory Fish
IV. Electronic Access
(NADA) related to AquAdvantage Encyclopedia), we found that the
Salmon, a GE Atlantic salmon. This is composition, nutritional profile, and Persons with access to the Internet
FDA’s first approval of an NADA in safety of food from AquAdvantage may obtain the draft guidance at http://
support of a GE animal for use as food. Salmon do not differ from food from www.fda.gov/FoodGuidances or http://
According to information in the NADA, non-GE, farm-raised Atlantic salmon in www.regulations.gov. Use the FDA Web
AquAdvantage Salmon is genetically any material way, and thus it is as safe site listed in the previous sentence to
engineered to reach market size in a and nutritious as food from non-GE, find the most current version of the
shorter period than non-GE farm-raised farm-raised Atlantic salmon. For these guidance.
Atlantic salmon. FDA’s Center for reasons, we concluded that there is no Dated: November 19, 2015.
Veterinary Medicine reviewed the basis to require additional labeling of Leslie Kux,
NADA and made a determination food derived from AquAdvantage Associate Commissioner for Policy.
concerning the safety and effectiveness Salmon.2 3 [FR Doc. 2015–29904 Filed 11–23–15; 8:45 am]
of the new animal drug in II. Guidance on Voluntary Labeling BILLING CODE 4164–01–P
AquAdvantage Salmon.
Recognizing that some consumers are
In terms of labeling of food derived
interested in whether a food contains
from AquAdvantage Salmon, the law DEPARTMENT OF HEALTH AND
GE Atlantic salmon and some
requires, among other things, that the HUMAN SERVICES
manufacturers may want to respond to
label includes a name that accurately
this consumer interest, we developed Food and Drug Administration
describes the basic nature of a food and
this draft guidance to assist food
any other information that is considered [Docket No. FDA–2000–D–0075]
manufacturers that wish to voluntarily
material with regard to consequences
label their food product or ingredients
that may result from the use of the food. Voluntary Labeling Indicating Whether
(for humans or animals) as either
In a 1992 policy on foods derived from Foods Have or Have Not Been Derived
new plant varieties and a 2001 draft 1 See
From Genetically Engineered Plants;
57 FR 22984, May 29, 1992.
guidance on voluntary labeling of food 2 We note that, if a different GE salmon is
Guidance for Industry; Availability
from GE plants, we explained that: developed in the future, we will separately assess
AGENCY: Food and Drug Administration,
Name changes are appropriate when a the data and information about that salmon to
mstockstill on DSK4VPTVN1PROD with NOTICES
determine whether it differs materially from non-GE HHS.
food from a GE plant is materially
different from its traditional
salmon and, as such, whether additional labeling ACTION: Notice of availability.
would be required on food derived from that
counterpart, such that the common or salmon. SUMMARY: The Food and Drug
usual name no longer adequately 3 Memorandum to File: Office of Nutrition,
Administration (FDA or we) is
describes the new food; or when there Labeling and Dietary Supplements, CFSAN:
Evaluation of data and information and
announcing the availability of a
are other material differences that affect recommendations related to the labeling of food guidance for industry entitled
the food’s nutritional or functional from AquAdvantage Salmon. ‘‘Voluntary Labeling Indicating Whether
VerDate Sep<11>2014 17:20 Nov 23, 2015 Jkt 238001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\24NON1.SGM 24NON1](https://thefederalregister.org/doc/80_FR_73420/page/1.svg)
![73198 Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Notices
We do not estimate any reporting (Catalogue of Federal Domestic Assistance DEPARTMENT OF HOMELAND
burden or third party disclosure burden Program Nos. 93.855, Allergy, Immunology, SECURITY
associated with this information and Transplantation Research; 93.856,
collection. Manufacturers who want to Microbiology and Infectious Diseases Coast Guard
Research, National Institutes of Health, HHS)
make use of this voluntary labeling [USCG–2015–1005]
claim option are considered to be those Dated: November 18, 2015.
that already have such wording on their Natasha M. Copeland, Merchant Mariner Medical Advisory
products’ labels. We do not expect that Program Analyst, Office of Federal Advisory Committee; Vacancies
this guidance will cause labels already Committee Policy.
in the marketplace to need to be re- [FR Doc. 2015–29854 Filed 11–23–15; 8:45 am] AGENCY: Coast Guard, DHS.
worded. BILLING CODE 4140–01–P ACTION: Request for applications.
III. Electronic Access SUMMARY: The Coast Guard seeks
Persons with access to the Internet DEPARTMENT OF HEALTH AND applications for membership on the
may obtain the guidance at http://www. HUMAN SERVICES Merchant Mariner Medical Advisory
fda.gov/FoodGuidances or http:// Committee. The Merchant Mariner
www.regulations.gov. Use the FDA Web National Institutes of Health Medical Advisory Committee provides
site listed in the previous sentence to advice and recommendations to the
find the most current version of the Center for Scientific Review; Notice of Secretary on matters related to medical
guidance. Closed Meeting certification determinations for issuance
Dated: November 19, 2015. of licenses, certificates of registry, and
Pursuant to section 10(d) of the merchant mariners’ documents; medical
Leslie Kux, Federal Advisory Committee Act, as standards and guidelines for the
Associate Commissioner for Policy. amended (5 U.S.C. App.), notice is physical qualifications of operators of
[FR Doc. 2015–29903 Filed 11–23–15; 8:45 am] hereby given of the following meeting. commercial vessels; medical examiner
BILLING CODE 4164–01–P The meeting will be closed to the education; and medical research.
public in accordance with the Applicants selected for service on the
provisions set forth in sections Merchant Mariner Medical Advisory
DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Committee via this solicitation will not
HUMAN SERVICES as amended. The grant applications and begin their respective term until August
National Institutes of Health the discussions could disclose 8, 2016.
confidential trade secrets or commercial DATES: Completed applications should
National Institute of Allergy and property such as patentable material, reach the Coast Guard on or before
Infectious Diseases; Notice of Closed and personal information concerning January 25, 2016.
Meeting individuals associated with the grant
ADDRESSES: Applicants should send a
applications, the disclosure of which
Pursuant to section 10(d) of the cover letter expressing interest in an
would constitute a clearly unwarranted
Federal Advisory Committee Act, as appointment to the Merchant Mariner
invasion of personal privacy.
amended (5 U.S.C. App.), notice is Medical Advisory Committee that also
hereby given of the following meeting. Name of Committee: Center for Scientific identifies which membership category
Review Special Emphasis Panel; the applicant is applying under, along
The meeting will be closed to the
Fellowships: Physiology and Pathobiology of
public in accordance with the with a resume detailing the applicant’s
Cardiovascular and Respiratory Systems.
provisions set forth in sections Date: November 23–24, 2015. experience via one of the following
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Time: 8:00 a.m. to 3:30 p.m. methods:
as amended. The contract proposals and Agenda: To review and evaluate grant • By Email: ashley.e.holm@uscg.mil.
the discussions could disclose applications. • By Fax: 202–372–4908.
confidential trade secrets or commercial Place: The St. Regis Washington, DC, 923 • By Mail: Lieutenant Ashley Holm,
property such as patentable material, 16th St.NW., Washington, DC 20006. Alternate Designated Federal Officer of
and personal information concerning Contact Person: Abdelouahab Aitouche, the Merchant Mariner Medical Advisory
individuals associated with the contract Ph.D., Scientific Review Officer, Center for Committee, Commandant, Mariner
Scientific Review, National Institutes of Credentialing Program Policy Division
proposals, the disclosure of which Health, 6701 Rockledge Drive, Room 4222,
would constitute a clearly unwarranted (CG–CVC–4), U.S. Coast Guard, 2703
MSC 7812, Bethesda, MD 20892, 301–435–
invasion of personal privacy. 2365, aitouchea@csr.nih.gov. Martin Luther King Jr. Ave. SE., Stop
Name of Committee: National Institute of
7501 Washington, DC 20593–7501.
This notice is being published less than 15
Allergy and Infectious Diseases Special days prior to the meeting due to the timing FOR FURTHER INFORMATION CONTACT:
Emphasis Panel, NIAID Investigator Initiated limitations imposed by the review and Lieutenant Ashley Holm, Alternate
Program Project Applications (P01). funding cycle. Designated Federal Officer of the
Date: December 17, 2015. (Catalogue of Federal Domestic Assistance Merchant Mariner Medical Advisory
Time: 12:00 p.m. to 4:00 p.m. Program Nos. 93.306, Comparative Medicine; Committee, Commandant, Mariner
Agenda: To review and evaluate grant 93.333, Clinical Research, 93.306, 93.333,
applications. Credentialing Program Policy Division
93.337, 93.393–93.396, 93.837–93.844, (CG–CVC–4), U.S. Coast Guard, 2703
Place: National Institutes of Health, Room
93.846–93.878, 93.892, 93.893, National Martin Luther King Jr. Ave. SE., Stop
mstockstill on DSK4VPTVN1PROD with NOTICES
4H200 A/B, 5601 Fishers Lane, Rockville,
Institutes of Health, HHS)
MD 20892, (Telephone Conference Call). 7501 Washington, DC 20593–7501,
Contact Person: Kelly Y. Poe, Ph.D., Dated: November 18, 2015. ashley.e.holm@uscg.mil, phone: 202–
Scientific Review Officer, Scientific Review David Clary, 372–1128, fax: 202–372–4908.
Program, Division of Extramural Activities,
Program Analyst, Office of Federal Advisory SUPPLEMENTARY INFORMATION: The
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Committee Policy. Merchant Mariner Medical Advisory
NIAID, 5601 Fishers Lane, MSC 9823,
Bethesda, MD 20892–9823, (240) 669–5036, [FR Doc. 2015–29853 Filed 11–23–15; 8:45 am] Committee was established under
poeky@mail.nih.gov. BILLING CODE 4140–01–P Section 210 of the Coast Guard
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Document Created: 2015-12-14 14:09:16
Document Modified: 2015-12-14 14:09:16
| 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 of availability. | |
| Dates | Submit either electronic or written comments on the guidance at any time. Fax written comments on the collection of information by December 24, 2015. | |
| Contact | Regarding human food issues: Andrea Krause, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371. Regarding animal food issues: Kathleen Jones, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-7077. Regarding the information collection: 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 73194 |
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