81 FR 21577 - Donor Screening Recommendations To Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability; Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 70 (April 12, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 70 (April 12, 2016)
| Page Range | 21577-21577 | |
| FR Document | 2016-08330 |
[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)] [Notices] [Page 21577] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-08330] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0768] Donor Screening Recommendations To Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability; correction. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Monday, March 7, 2016 (81 FR 11808). The document announced a guidance for industry entitled ``Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products.'' The document was published with an incorrect docket number in the ADDRESSES section. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy, Planning, Legislation, and Analysis, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993- 0002, 301-796-9115. SUPPLEMENTARY INFORMATION: In FR Doc. 2016-04893, appearing on page 11808 in the Federal Register of Monday, March 7, 2016, the following correction is made: 1. On page 11808, in the third column, the docket number is corrected to read ``FDA-2016-D-0768''. Dated: April 6, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-08330 Filed 4-11-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 70 / Tuesday, April 12, 2016 / Notices 21577
‘‘Search’’ box and follow the prompts entitled ‘‘Safety Considerations for Dated: April 6, 2016.
and/or go to the Division of Dockets Product Design to Minimize Medication Leslie Kux,
Management, 5630 Fishers Lane, Rm. Errors.’’ The Agency has carefully Associate Commissioner for Policy.
1061, Rockville, MD 20852. reviewed and considered the comments [FR Doc. 2016–08335 Filed 4–11–16; 8:45 am]
Submit written requests for single it received in developing this final
BILLING CODE 4164–01–P
copies of this guidance to the Division version of the guidance. The Agency has
of Drug Information, Center for Drug made revisions to the guidance to
Evaluation and Research, Food and address public comments requesting
DEPARTMENT OF HEALTH AND
Drug Administration, 10001 New clarifications and implement formatting
changes for improved readability as it HUMAN SERVICES
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993– deemed appropriate. The Agency also
Food and Drug Administration
0002. Send one self-addressed adhesive moved recommendations appropriate
label to assist that office in processing for labels and labeling to a separate
your requests. See the SUPPLEMENTARY guidance. The guidance announced in [Docket No. FDA–2016–D–0768]
INFORMATION section for electronic this notice finalizes the draft guidance
dated December 2012. Donor Screening Recommendations
access to the guidance document.
This guidance is being issued To Reduce the Risk of Transmission of
FOR FURTHER INFORMATION CONTACT:
consistent with FDA’s good guidance Zika Virus by Human Cells, Tissues,
Irene Z. Chan, Center for Drug
practices regulation (21 CFR 10.115). and Cellular and Tissue-Based
Evaluation and Research, Food and
The guidance represents the Agency’s Products; Guidance for Industry;
Drug Administration, 10903 New
current thinking on addressing safety Availability; Correction
Hampshire Ave., Bldg. 22, Rm. 4420,
Silver Spring, MD 20993–0002, 301– achieved through drug product design
to minimize medication errors. It does AGENCY: Food and Drug Administration,
796–3962.
not establish any rights for any person HHS.
SUPPLEMENTARY INFORMATION:
and is not binding on FDA or the public. ACTION: Notice of availability;
I. Background You can use an alternative approach if correction.
FDA is announcing the availability of it satisfies the requirements of the
a guidance for industry entitled ‘‘Safety applicable statutes and regulations.
SUMMARY: The Food and Drug
Considerations for Product Design to II. Comments Administration (FDA) is correcting a
Minimize Medication Errors.’’ The Interested persons may submit either notice that appeared in the Federal
guidance is intended for sponsors of electronic comments regarding this Register of Monday, March 7, 2016 (81
INDs; applicants of NDAs, BLAs, and document to http://www.regulations.gov FR 11808). The document announced a
ANDAs; and manufacturers of or written comments to the Division of guidance for industry entitled ‘‘Donor
prescription drugs marketed without an Dockets Management (see ADDRESSES). It Screening Recommendations to Reduce
approved application or OTC is only necessary to send one set of the Risk of Transmission of Zika Virus
monograph drugs. This guidance comments. Identify comments with the by Human Cells, Tissues, and Cellular
provides sponsors, applicants, and docket number found in brackets in the and Tissue-Based Products.’’ The
manufacturers with a set of principles to heading of this document. Received document was published with an
consider while developing drug comments may be seen in the Division
products using a systems approach to incorrect docket number in the
of Dockets Management between 9 a.m. ADDRESSES section. This document
minimize medication errors relating to and 4 p.m., Monday through Friday, and
product design and container closure corrects that error.
will be posted to the docket at http://
design. The recommendations in this www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Lisa
guidance document are intended to Granger, Office of Policy, Planning,
provide best practices on how to III. Paperwork Reduction Act of 1995 Legislation, and Analysis, Food and
improve the drug product and container This guidance refers to previously Drug Administration, 10903 New
closure design for all prescription and approved collections of information Hampshire Ave., Bldg. 32, Rm. 3330,
nonprescription drug products. The found in FDA regulations. These Silver Spring, MD 20993–0002, 301–
guidance also provides examples of collections of information are subject to 796–9115.
product designs that resulted in review by the Office of Management and
postmarketing error. Budget (OMB) under the Paperwork SUPPLEMENTARY INFORMATION: In FR Doc.
This guidance document, which Reduction Act of 1995 (44 U.S.C. 3501– 2016–04893, appearing on page 11808
focuses on minimizing risks associated 3520). The collections of information in in the Federal Register of Monday,
with the design of the drug product and 21 CFR part 312 have been approved March 7, 2016, the following correction
its container closure system, is the first under OMB control number 0910–0014. is made:
in a series of three planned guidances to The collections of information in 21 1. On page 11808, in the third
minimize or eliminate hazards CFR part 314 have been approved under column, the docket number is corrected
contributing to medication errors. The OMB control number 0910–0001. The to read ‘‘FDA–2016–D–0768’’.
second guidance focuses on minimizing collections of information in 21 CFR
risks with the design of drug product Dated: April 6, 2016.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
part 601 have been approved under
container labels and carton labeling. OMB control number 0910–0338. Leslie Kux,
The third guidance focuses on Associate Commissioner for Policy.
minimizing risks when developing and IV. Electronic Access
[FR Doc. 2016–08330 Filed 4–11–16; 8:45 am]
selecting proposed proprietary names You may obtain the document at
BILLING CODE 4164–01–P
for drugs. http://www.fda.gov/Drugs/Guidance
In the Federal Register of December ComplianceRegulatoryInformation/
13, 2012 (77 FR 74196), FDA announced Guidances/default.htm or http://
the availability of the draft guidance www.regulations.gov.
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Document Created: 2016-04-12 00:47:22
Document Modified: 2016-04-12 00:47:22
| 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; correction. | |
| Contact | Lisa Granger, Office of Policy, Planning, Legislation, and Analysis, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993- 0002, 301-796-9115. | |
| FR Citation | 81 FR 21577 |
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