83 FR 31760 - Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 131 (July 9, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 131 (July 9, 2018)
| Page Range | 31760-31762 | |
| FR Document | 2018-14537 |
[Federal Register Volume 83, Number 131 (Monday, July 9, 2018)] [Notices] [Pages 31760-31762] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-14537] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0545] Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry.'' The guidance document provides blood establishments that collect Whole Blood and blood components with revised recommendations to reduce the risk of transmission of Zika virus (ZIKV) by blood and blood components. The guidance does not apply to the collection of Source Plasma. The guidance announced in this notice supersedes the document of the same title dated August 2016 (August 2016 Guidance). DATES: The announcement of the guidance is published in the Federal Register on July 9, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: 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, [[Page 31761]] 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-2016-D-0545 for ``Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry.'' Received comments 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled ``Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry.'' The guidance provides blood establishments that collect Whole Blood and blood components with revised recommendations to reduce the risk of transmission of ZIKV by blood and blood components. The guidance does not apply to the collection of Source Plasma. This guidance supersedes the August 2016 Guidance. In the August 2016 Guidance, FDA recognized ZIKV as a relevant transfusion-transmitted infection under 21 CFR 630.3(h) and recommended universal individual donation nucleic acid testing (ID NAT) for ZIKV or the use of an FDA-approved pathogen reduction device. Since 2016, the number of ZIKV disease cases in the U.S. States and territories has decreased considerably. In addition, FDA has licensed a nucleic acid screening test(s) for the detection of ZIKV in individual or pooled samples. Considering the changing epidemiology of ZIKV in the United States and the availability of licensed screening tests, FDA is revising the recommendations contained in the August 2016 Guidance. In this guidance FDA explains that, in order to comply with the testing requirements in 21 CFR 610.40(a)(3), blood establishments must test all donations collected in the United States and its territories with a licensed nucleic acid test for ZIKV, using either ID NAT or minipool (MP) NAT. The guidance explains the basis for FDA's determination that universal MP NAT screening, with certain conditions identified to trigger ID NAT when local mosquito-borne ZIKV transmission is presumed in a collection area, provides an adequate and appropriate safeguard against the current and future risk of ZIKV transmission through blood transfusion. Alternatively, blood establishments can use an FDA- approved pathogen reduction device. The revised recommendations are less burdensome for blood establishments because fewer tests will be performed when donations are tested by MP NAT compared to ID NAT. However, the recommendations are consistent with public health considering the changing course of the ZIKV epidemic in the United States and the sensitivity of the licensed test(s) to detect ZIKV in blood donation. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2) without initially seeking prior comment because the Agency has determined that prior public participation is not feasible or appropriate. Specifically, we are not seeking comments because the guidance presents a less burdensome policy for reducing the risk of transfusion- transmitted ZIKV that is consistent with public health. The guidance represents the current thinking of FDA on recommendations for reducing the risk of Zika virus transmission by blood and blood components. It does not establish [[Page 31762]] 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. This guidance is not subject to Executive Order 12866. II. 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 parts 601 and 640, and Form FDA 356h have been approved under OMB control number 0910-0338; and the collections of information in 21 CFR parts 606 and 630 have been approved under OMB control number 0910-0116. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: June 28, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-14537 Filed 7-6-18; 8:45 am] BILLING CODE 4164-01-P
![31760 Federal Register / Vol. 83, No. 131 / Monday, July 9, 2018 / Notices
‘‘Indications and Usage Section of This guidance is one in a series of Information/Guidances/default.htm, or
Labeling for Human Prescription Drug guidances FDA is developing or has https://www.regulations.gov.
and Biological Products—Content and developed to assist applicants with the Dated: June 29, 2018.
Format.’’ This guidance provides content and format of labeling for Leslie Kux,
recommendations on the general human prescription drug and biological
Associate Commissioner for Policy.
principles to consider when drafting an products. In the Federal Register of
indication and how to write, organize, [FR Doc. 2018–14535 Filed 7–6–18; 8:45 am]
January 24, 2006 (71 FR 3922), FDA
and format the information in the published a final rule on labeling for BILLING CODE 4164–01–P
Indications and Usage section of the human prescription drug and biological
labeling. The draft guidance provides products. The final rule and additional
recommendations on what information DEPARTMENT OF HEALTH AND
guidances on labeling can be accessed at
to include in the indication and when HUMAN SERVICES
https://www.fda.gov/Drugs/Guidance
limitations of use should be considered ComplianceRegulatoryInformation/Laws Food and Drug Administration
for the Indications and Usage section. ActsandRules/ucm084159.htm. The
The Indications and Usage section labeling requirements and these [Docket No. FDA–2016–D–0545]
must state that the drug is indicated for guidances are intended to make
the treatment, prevention, mitigation, information in prescription drug Revised Recommendations for
cure, or diagnosis of a recognized labeling easier for health care Reducing the Risk of Zika Virus
disease or condition, or of a practitioners to access, read, and use. Transmission by Blood and Blood
manifestation of a recognized disease or Components; Guidance for Industry;
This draft guidance is being issued Availability
condition, or for the relief of symptoms consistent with FDA’s good guidance
associated with a recognized disease or practices regulation (21 CFR 10.115). AGENCY: Food and Drug Administration,
condition.1 The draft guidance describes The draft guidance, when finalized, will HHS.
how to clearly convey such information represent the current thinking of FDA
and addresses circumstances where ACTION: Notice of availability.
on the content and format of the
other information in addition to the SUMMARY: The Food and Drug
Indications and Usage section of
identification of the disease or condition Administration (FDA or Agency) is
labeling for human prescription drug
may be warranted. announcing the availability of a final
The draft guidance describes and biological products. It does not
establish any rights for any person and guidance for industry entitled ‘‘Revised
circumstances in which an indication Recommendations for Reducing the Risk
may be broader than the specific is not binding on FDA or the public.
You can use an alternative approach if of Zika Virus Transmission by Blood
parameters of the clinical studies and Blood Components; Guidance for
supporting approval, as well as those it satisfies the requirements of the
applicable statutes and regulations. This Industry.’’ The guidance document
where a narrower indication may be provides blood establishments that
appropriate, and explains that the guidance is not subject to Executive
Order 12866. collect Whole Blood and blood
Indications and Usage section needs to components with revised
make clear the scope of the indication. II. The Paperwork Reduction Act of recommendations to reduce the risk of
The draft guidance also describes 1995 transmission of Zika virus (ZIKV) by
circumstances in which an indication in blood and blood components. The
an age group broader than the This draft guidance refers to
previously approved collections of guidance does not apply to the
population that was studied may be
information found in FDA regulations. collection of Source Plasma. The
considered for an adult population.
These collections of information are guidance announced in this notice
However, this approach is generally not
subject to review by the Office of supersedes the document of the same
appropriate across pediatric populations
Management and Budget (OMB) under title dated August 2016 (August 2016
or between adult and pediatric
the Paperwork Reduction Act of 1995 Guidance).
populations because of the statutory
requirements related to pediatric (44 U.S.C. 3501–3520). The collections DATES: The announcement of the
assessments and the unique clinical of information in 21 CFR 201.56 and guidance is published in the Federal
considerations for pediatric patients. 201.57 have been approved under OMB Register on July 9, 2018.
For example, pediatric patients may control number 0910–0572; the ADDRESSES: You may submit either
metabolize drugs differently from adults collections of information in 21 CFR electronic or written comments on
(in an age-related manner), are 312.41 have been approved under OMB Agency guidances at any time as
susceptible to different safety risks, and control number 0910–0014; the follows:
often require different dosing regimens, collections of information in 21 CFR
even after correction for weight. For 314.126(c) and 314.70 have been Electronic Submissions
these reasons, FDA recommends that approved under OMB control number Submit electronic comments in the
age groups should be included in 0910–0001; and the collections of following way:
indications. An indication should state information in 21 CFR 601.12 have been • Federal eRulemaking Portal:
that a drug is approved, for example, ‘‘in approved under OMB control number https://www.regulations.gov. Follow the
adults,’’ ‘‘in pediatric patients X years of 0910–0338. instructions for submitting comments.
age and older,’’ or ‘‘in adults and Comments submitted electronically,
III. Electronic Access
including attachments, to https://
sradovich on DSK3GMQ082PROD with NOTICES
pediatric patients X years of age and
older.’’ FDA is interested in obtaining Persons with access to the internet www.regulations.gov will be posted to
information and public comment on this may obtain the draft guidance at https:// the docket unchanged. Because your
recommendation and the implications www.fda.gov/Drugs/Guidance comment will be made public, you are
of routinely including age groups in ComplianceRegulatoryInformation/ solely responsible for ensuring that your
indications. Guidances/default.htm, https:// comment does not include any
www.fda.gov/BiologicsBloodVaccines/ confidential information that you or a
1 See 21 CFR 201.57(c)(2). GuidanceComplianceRegulatory third party may not wish to be posted,
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![31762 Federal Register / Vol. 83, No. 131 / Monday, July 9, 2018 / Notices
any rights for any person and is not Place: National Institutes of Health, 6701 as amended. The grant applications and
binding on FDA or the public. You can Rockledge Drive, Bethesda, MD 20892 the discussions could disclose
use an alternative approach if it satisfies (Telephone Conference Call). confidential trade secrets or commercial
Contact Person: Denise Wiesch, Ph.D.,
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Scientific Review Officer, Center for
statutes and regulations. This guidance Scientific Review, National Institutes of and personal information concerning
is not subject to Executive Order 12866. Health, 6701 Rockledge Drive, Room 3138, individuals associated with the grant
II. Paperwork Reduction Act of 1995 MSC 7770, Bethesda, MD 20892, (301) 437– applications, the disclosure of which
3478, wieschd@csr.nih.gov. would constitute a clearly unwarranted
This guidance refers to previously Name of Committee: Center for Scientific invasion of personal privacy.
approved collections of information Review Special Emphasis Panel; Networks Name of Committee: National Institute of
found in FDA regulations. These and Behavior in Psychiatric Disorders. Diabetes and Digestive and Kidney Diseases
collections of information are subject to Date: July 25, 2018. Special Emphasis Panel; Environmental
review by the Office of Management and Time: 2:00 p.m. to 5:00 p.m. Determinants of Diabetes.
Budget (OMB) under the Paperwork Agenda: To review and evaluate grant Date: July 9, 2018.
Reduction Act of 1995 (44 U.S.C. 3501– applications. Time: 1:00 p.m. to 3:30 p.m.
3520). The collections of information in Place: National Institutes of Health, 6701 Agenda: To review and evaluate grant
21 CFR parts 601 and 640, and Form Rockledge Drive, Bethesda, MD 20892 applications.
(Telephone Conference Call).
FDA 356h have been approved under Place: National Institutes of Health, Two
Contact Person: Julius Cinque, MS, Democracy Plaza, 6707 Democracy
OMB control number 0910–0338; and Scientific Review Officer, Center for
the collections of information in 21 CFR Boulevard, Bethesda, MD 20892 (Telephone
Scientific Review, National Institutes of Conference Call).
parts 606 and 630 have been approved Health, 6701 Rockledge Drive, Room 5186,
under OMB control number 0910–0116. Contact Person: Elena Sanovich, Ph.D.,
MSC 7846, Bethesda, MD 20892, (301) 435–
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III. Electronic Access DEA, NIDDK, National Institutes of Health,
Name of Committee: Center for Scientific Room 7351, 6707 Democracy Boulevard,
Persons with access to the internet Review Special Emphasis Panel; PAR17–158: Bethesda, MD 20892–2542, 301–594–8886,
may obtain the guidance at either Epigenomes and Connectomes in Psychiatric sanoviche@mail.nih.gov.
https://www.fda.gov/Biologics Disorders.
This notice is being published less than 15
BloodVaccines/GuidanceCompliance Date: July 26, 2018.
days prior to the meeting due to the timing
RegulatoryInformation/Guidances/ Time: 2:00 p.m. to 5:00 p.m.
limitations imposed by the review and
default.htm or https:// Agenda: To review and evaluate grant
funding cycle.
www.regulations.gov. applications.
Place: National Institutes of Health, 6701 Name of Committee: National Institute of
Dated: June 28, 2018. Rockledge Drive, Bethesda, MD 20892 Diabetes and Digestive and Kidney Diseases
Leslie Kux, (Telephone Conference Call). Special Emphasis Panel; Review of Planning
Contact Person: Julius Cinque, MS, Grant Application (U34).
Associate Commissioner for Policy.
Scientific Review Officer, Center for Date: July 12, 2018.
[FR Doc. 2018–14537 Filed 7–6–18; 8:45 am] Time: 6:00 p.m. to 7:30 p.m.
Scientific Review, National Institutes of
BILLING CODE 4164–01–P
Health, 6701 Rockledge Drive, Room 5186, Agenda: To review and evaluate grant
MSC 7846, Bethesda, MD 20892, (301) 435– applications.
1252, cinquej@csr.nih.gov. Place: National Institutes of Health, Two
DEPARTMENT OF HEALTH AND (Catalogue of Federal Domestic Assistance
Democracy Plaza, 6707 Democracy
HUMAN SERVICES Boulevard, Bethesda, MD 20892 (Telephone
Program Nos. 93.306, Comparative Medicine;
Conference Call).
93.333, Clinical Research, 93.306, 93.333,
National Institutes of Health Contact Person: Barbara A. Woynarowska,
93.337, 93.393–93.396, 93.837–93.844,
Ph.D., Scientific Review Officer, Review
93.846–93.878, 93.892, 93.893, National
Center for Scientific Review; Notice of Institutes of Health, HHS)
Branch, DEA, NIDDK, National Institutes of
Closed Meetings Health, Room 754, 6707 Democracy
Dated: July 3, 2018. Boulevard, Bethesda, MD 20892–5452, (301)
Pursuant to section 10(d) of the Sylvia L. Neal, 402–7172, woynarowskab@niddk.nih.gov.
Federal Advisory Committee Act, as Program Analyst, Office of Federal Advisory This notice is being published less than 15
amended, notice is hereby given of the Committee Policy. days prior to the meeting due to the timing
following meetings. [FR Doc. 2018–14647 Filed 7–6–18; 8:45 am] limitations imposed by the review and
The meetings will be closed to the funding cycle.
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public in accordance with the Name of Committee: National Institute of
provisions set forth in sections Diabetes and Digestive and Kidney Diseases
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., DEPARTMENT OF HEALTH AND
Special Emphasis Panel; NIDDK U34
as amended. The grant applications and Telephone Review.
HUMAN SERVICES Date: July 13, 2018.
the discussions could disclose
confidential trade secrets or commercial Time: 3:30 p.m. to 4:30 p.m.
National Institutes of Health Agenda: To review and evaluate grant
property such as patentable material,
applications.
and personal information concerning National Institute of Diabetes and Place: National Institutes of Health, Two
individuals associated with the grant Digestive and Kidney Diseases; Notice Democracy Plaza, 6707 Democracy
applications, the disclosure of which of Closed Meetings Boulevard, Bethesda, MD 20892 (Telephone
would constitute a clearly unwarranted Conference Call).
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Name of Committee: Center for Scientific amended, notice is hereby given of the
Review Special Emphasis Panel; PAR Panel: DEA, NIDDK, National Institutes of Health,
Pregnancy in Women with Disabilities.
following meetings. Room 7023, 6707 Democracy Boulevard,
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Agenda: To review and evaluate grant provisions set forth in sections This notice is being published less than 15
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Document Created: 2018-07-07 00:41:43
Document Modified: 2018-07-07 00:41:43
| 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 | The announcement of the guidance is published in the Federal Register on July 9, 2018. | |
| Contact | Tami Belouin, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911. | |
| FR Citation | 83 FR 31760 |
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