83 FR 39450 - Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 154 (August 9, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 154 (August 9, 2018)
| Page Range | 39450-39453 | |
| FR Document | 2018-17024 |
[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)] [Notices] [Pages 39450-39453] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-17024] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2495] Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with the guidance to assist manufacturers who wish to voluntarily label their foods (human and animal) as being made with or without bioengineering, or the use of bioengineered ingredients, to ensure that labeling is truthful and not misleading. [[Page 39451]] DATES: Submit either electronic or written comments on the collection of information by October 9, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 9, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2018-N-2495 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (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(c) 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, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants OMB Control Number 0910-0807--Extension This information collection supports Agency guidance. Section 403 of the Federal Food, Drug, and Cosmetic Act (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 [[Page 39452]] 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'' (the 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, which is often referred to as ``rDNA technology,'' ``genetic engineering,'' ``biotechnology,'' or ``bioengineering,'' and more recently as ``modern biotechnology.'' The 1992 Policy provides guidance to industry on scientific and regulatory issues related to bioengineered foods and solicited written comments from interested persons. It includes guidance on questions to be answered by developers of foods from new plant varieties to ensure that the new products are safe and comply with applicable legal requirements. The 1992 Policy stated that the method of development of a new plant variety, including plants developed using bioengineering, is not information that is material under section 201(n) of the FD&C Act and, therefore, would not be required in the labeling of food. This conclusion is consistent with our historic interpretation of section 201(n) of the FD&C Act, in that the method of plant breeding is not required to be disclosed in labeling. 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. 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 guidance is available at https://www.fda.gov/FoodGuidances. 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 that claim that a product is not developed using bioengineered 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. 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. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. The number of recordkeepers and respondents reflects the number of food products that are labeled using the terms ``biotechnology'' and ``GMO'' (genetically modified organism). 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 estimates of the recordkeeping burden (table 1 of this document) on data from Labelbase by FoodEssentials. Labelbase is a custom online system for accessing 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 website 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'' [[Page 39453]] 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). 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 reworded. Dated: August 3, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-17024 Filed 8-8-18; 8:45 am] BILLING CODE 4164-01-P
![39450 Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices
Generic Clearance for the Collection of other characteristics for the purpose of providing FDA information about the
Quantitative Data on Tobacco Products determining the need for and perceived effectiveness of messages,
and Communications; OMB Control developing health messages, advertisements, and materials in
Number 0910–0810—Extension communication strategies, and public reaching and successfully
information programs and (2) pretesting communicating with their intended
In order to conduct educational and these health messages, strategies, and audiences. Quantitative testing
public information programs relating to program components while they are in messages and other materials with a
tobacco use as authorized by section developmental form to assess audience sample of the target audience will allow
1003(d)(2)(D) of the Federal Food, Drug, comprehension, reactions, and FDA to refine messages, advertisements,
and Cosmetic Act (21 U.S.C. perceptions. and materials, including questionnaires
393(d)(2)(D)), FDA’s Center for Tobacco Formative pretesting is a staple of best or images, directed at consumers while
Products will create and use a variety of practices in communications research. the materials are still in the
media to inform and educate the public, Obtaining voluntary feedback from developmental stage.
tobacco retailers, and health intended audiences during the
professionals about the risks of tobacco In the Federal Register of February
development of messages and materials 13, 2018 (83 FR 6190), FDA published
use, how to quit using tobacco products, is crucial for the success of every
and FDA’s role in regulating tobacco. a 60-day notice requesting public
communication program. The purpose comment on the proposed collection of
To ensure that these health of obtaining information from formative information. One PRA-related comment
communication messages have the pretesting is that it allows FDA to was received.
highest potential to be received, improve materials and strategies while
understood, and accepted by those for revisions are still affordable and Comment: The comment recommends
whom they are intended, the Center for possible. Formative pretesting can also that FDA should research and develop
Tobacco Products will conduct research avoid potentially expensive and communications about educating adults
and studies relating to the control and dangerous unintended outcomes caused about the continuum of risk, and
prevention of disease. In conducting by audiences’ interpreting messages in a educating adults to not provide tobacco
such research, FDA will employ way that was not intended by the products to youth.
formative pretests. Formative pretests drafters. By maximizing the Response: FDA appreciates the
are conducted on a small scale, and effectiveness of messages and strategies comment. The content and focus on
their focus is on developing and for reaching targeted audiences, the studies submitted through this generic
assessing the likely effectiveness of frequency with which tobacco clearance will depend on Agency
communications with specific target communication messages need to be priorities and needs, and is not yet
audiences. This type of research modified should be greatly reduced. determined at this time.
involves: (1) Assessing audience The voluntary information collected FDA estimates the burden of this
knowledge, attitudes, behaviors, and will serve the primary purpose of collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Screener ............................................................................... 130,500 1 130,500 0.083 (5 10,831
minutes)
Self-Administered Surveys ................................................... 27,000 1 27,000 0.33 (20 8,910
minutes)
Total .............................................................................. ........................ ........................ ........................ ........................ 19,741
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents to be DEPARTMENT OF HEALTH AND comment on the proposed collection of
included in each new survey will vary, HUMAN SERVICES certain information by the Agency.
depending on the nature of the material Under the Paperwork Reduction Act of
or message being tested and the target Food and Drug Administration 1995 (PRA), Federal Agencies are
audience. The burden for this required to publish notice in the
[Docket No. FDA–2018–N–2495] Federal Register concerning each
information collection extension is
proposed to increase by 12,613 hours proposed collection of information,
Agency Information Collection
since the last OMB approval. The including each proposed extension of an
Activities; Proposed Collection;
burden increase is due to an increase in existing collection of information, and
Comment Request; Voluntary Labeling
the number of respondents and the to allow 60 days for public comment in
Indicating Whether Foods Have or
response to the notice. This notice
categories of respondents. Have Not Been Derived From
solicits comments on the information
Dated: August 3, 2018. Genetically Engineered Plants
collection associated with the guidance
sradovich on DSK3GMQ082PROD with NOTICES
Leslie Kux, AGENCY: Food and Drug Administration, to assist manufacturers who wish to
Associate Commissioner for Policy. HHS. voluntarily label their foods (human and
[FR Doc. 2018–17044 Filed 8–8–18; 8:45 am] ACTION: Notice. animal) as being made with or without
bioengineering, or the use of
BILLING CODE 4164–01–P
SUMMARY: The Food and Drug bioengineered ingredients, to ensure
Administration (FDA or Agency) is that labeling is truthful and not
announcing an opportunity for public misleading.
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![Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices 39453
on the label (2,160 ¥ 1,140 = 1,020 DEPARTMENT OF HEALTH AND for reasons of safety or effectiveness or
products not organics; 540 ¥ 285 = 255 HUMAN SERVICES if FDA determines that the listed drug
manufacturers of not organic products). was withdrawn from sale for reasons of
In addition, the 54 livestock feed Food and Drug Administration safety or effectiveness (21 CFR 314.162).
suppliers are also organic producers, [Docket No. FDA–2018–P–0998]
A person may petition the Agency to
thus the 216 products attributed to these determine, or the Agency may
manufacturers already are considered to Determination That PROLIXIN determine on its own initiative, whether
be labeled ‘‘organic.’’ Thus, there are (Fluphenazine Hydrochloride) Tablets, a listed drug was withdrawn from sale
1,020 products made by 255 human 1 Milligram, 2.5 Milligrams, 5 for reasons of safety or effectiveness.
food and pet food manufacturers that Milligrams, and 10 Milligrams, Was Not This determination may be made at any
would need to substantiate that their Withdrawn From Sale for Reasons of time after the drug has been withdrawn
product or ingredient was not Safety or Effectiveness from sale, but must be made prior to
genetically engineered. approving an ANDA that refers to the
AGENCY: Food and Drug Administration, listed drug (§ 314.161 (21 CFR 314.161)).
We estimate that the burden of HHS. FDA may not approve an ANDA that
maintaining the documentation is a one- ACTION: Notice. does not refer to a listed drug.
time burden; the document to PROLIXIN (fluphenazine
substantiate that the product or SUMMARY: The Food and Drug hydrochloride) tablets, 1 mg, 2.5 mg, 5
ingredient was produced without Administration (FDA or Agency) has mg, and 10 mg, is the subject of NDA
genetic engineering only needs to be determined that PROLIXIN 011751, held by Apothecon
generated once and then kept on file. To (fluphenazine hydrochloride) tablets, 1 Pharmaceuticals, a Bristol-Myers Squibb
annualize this one-time burden, we milligram (mg), 2.5 mg, 5 mg, and 10 Company, and initially approved on
divide by 3 because paperwork burden mg, was not withdrawn from sale for March 15, 1967. PROLIXIN is indicated
collections are approved on a 3-year reasons of safety or effectiveness. This in the management of manifestations of
cycle (255/3 = 85). Thus, we estimate in determination will allow FDA to psychotic disorders.
approve abbreviated new drug In a letter dated October 5, 2006,
table 1 that, on average, 85
applications (ANDAs) for fluphenazine Bristol-Myers Squibb Company
manufacturers annually will collect and
hydrochloride tablets, 1 mg, 2.5 mg, 5 requested withdrawal of NDA 011751
keep information that substantiates their
mg, and 10 mg, if all other legal and for PROLIXIN (fluphenazine
label claim for four products (1,020 regulatory requirements are met.
products/3 = 340 products/85 hydrochloride) tablets, 1 mg, 2.5 mg, 5
FOR FURTHER INFORMATION CONTACT: mg, and 10 mg. In the Federal Register
manufacturers = 4 products per
Stacy Kane, Center for Drug Evaluation of February 11, 2009 (74 FR 6896), FDA
manufacturer).
and Research, Food and Drug announced that it was withdrawing
We estimate this one-time Administration, 10903 New Hampshire approval of NDA 011751, effective
recordkeeping burden to be 1 hour per Ave., Bldg. 51, Rm. 6236, Silver Spring, March 13, 2009.
product that makes use of a labeling MD 20993–0002, 301–796–8363, Hyman, Phelps & McNamara, P.C.
claim, which results in a burden of 1 Stacy.Kane@fda.hhs.gov. submitted a citizen petition dated
hour for a total annualized SUPPLEMENTARY INFORMATION: In 1984, March 5, 2018 (Docket No. FDA–2018–
recordkeeping burden of 340 hours (85 Congress enacted the Drug Price P–0998), under 21 CFR 10.30,
manufacturers × 4 records per Competition and Patent Term requesting that the Agency determine
manufacturer × 1 hour per record). Restoration Act of 1984 (Pub. L. 98–417) whether PROLIXIN (fluphenazine
We do not estimate any reporting (the 1984 amendments), which hydrochloride) tablets, 1 mg, 2.5 mg, 5
burden or third-party disclosure burden authorized the approval of duplicate mg, and 10 mg, was withdrawn from
associated with this information versions of drug products under an sale for reasons of safety or
collection. Manufacturers who want to ANDA procedure. ANDA applicants effectiveness.
make use of this voluntary labeling must, with certain exceptions, show that After considering the citizen petition
claim option are considered to be those the drug for which they are seeking and reviewing Agency records and
approval contains the same active based on the information we have at this
that already have such wording on their
ingredient in the same strength and time, FDA has determined under
products’ labels. We do not expect that
dosage form as the ‘‘listed drug,’’ which § 314.161 that PROLIXIN (fluphenazine
this guidance will cause labels already
is a version of the drug that was hydrochloride) tablets, 1 mg, 2.5 mg, 5
in the marketplace to need to be previously approved. ANDA applicants mg, and 10 mg, was not withdrawn for
reworded. do not have to repeat the extensive reasons of safety or effectiveness. The
Dated: August 3, 2018. clinical testing otherwise necessary to petitioner has identified no data or other
Leslie Kux, gain approval of an NDA. information suggesting that PROLIXIN
Associate Commissioner for Policy. The 1984 amendments include what (fluphenazine hydrochloride) tablets, 1
[FR Doc. 2018–17024 Filed 8–8–18; 8:45 am]
is now section 505(j)(7) of the Federal mg, 2.5 mg, 5 mg, and 10 mg, was
Food, Drug, and Cosmetic Act (21 U.S.C. withdrawn for reasons of safety or
BILLING CODE 4164–01–P
355(j)(7)), which requires FDA to effectiveness. We have carefully
publish a list of all approved drugs. reviewed our files for records
FDA publishes this list as part of the concerning the withdrawal of PROLIXIN
sradovich on DSK3GMQ082PROD with NOTICES
‘‘Approved Drug Products With (fluphenazine hydrochloride) tablets, 1
Therapeutic Equivalence Evaluations,’’ mg, 2.5 mg, 5 mg, and 10 mg, from sale.
which is known generally as the We have also independently evaluated
‘‘Orange Book.’’ Under FDA regulations, relevant literature and data for possible
drugs are removed from the list if the postmarketing adverse events. We have
Agency withdraws or suspends found no information that would
approval of the drug’s NDA or ANDA indicate that this drug product was
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Document Created: 2018-08-09 01:11:20
Document Modified: 2018-08-09 01:11:20
| 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 the collection of information by October 9, 2018. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 83 FR 39450 |
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