81 FR 60005 - 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 81, Issue 169 (August 31, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 169 (August 31, 2016)
| Page Range | 60005-60007 | |
| FR Document | 2016-20914 |
[Federal Register Volume 81, Number 169 (Wednesday, August 31, 2016)] [Notices] [Pages 60005-60007] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-20914] ----------------------------------------------------------------------- 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 document entitled ``Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry.'' The guidance document is notifying blood establishments that collect Whole Blood and blood components, that FDA has determined Zika virus (ZIKV) to be a relevant transfusion- transmitted infection (RTTI) and provides FDA's assessment. The guidance also provides recommendations to reduce the risk of transmission of ZIKV by Whole Blood and blood components. The guidance applies to the collection of Whole Blood and blood components. The guidance does not apply to the collection of Source Plasma. The guidance supersedes the February 2016 document entitled, ``Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry'' (February 2016 guidance), and the March 2016 document entitled, ``Questions and Answers Regarding `Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry' '' no later than 12 weeks after the date of the issuance of this guidance. Implementation of the guidance will be immediate for blood establishments that collect Whole Blood and blood components in States and territories with local transmission of ZIKV by mosquitos, and will be phased in over 4 to 12 weeks in other States and territories using a tiered, risk-based approach. Blood establishments should follow the recommendations in the February 2016 guidance until the recommendations in the guidance document have been fully implemented. DATES: The Agency is soliciting public comment, but is implementing this guidance immediately because the [[Page 60006]] Agency has determined that prior public participation is not feasible or appropriate. Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: 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-2016-D-0545 for ``Revised Recommendations for Reducing the Risk of Zika Virus; Guidance for Industry.'' 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 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: Jonathan McKnight, 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 guidance entitled ``Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry.'' The guidance is notifying blood establishments that collect Whole Blood and blood components that FDA has determined ZIKV to be an RTTI under 21 CFR 630.3(h)(2) and provides FDA's assessment. The guidance provides recommendations to reduce the risk of transmission of ZIKV by Whole Blood and blood components. The guidance does not apply to the collection of Source Plasma, which is used for further manufacture of plasma-derived products. If, based upon the available scientific evidence, the risk of ZIKV transmission by blood and blood components significantly changes, FDA may update the recommendations as warranted. In making this determination, FDA will consider available epidemiologic and other scientific evidence. The guidance supersedes the February 2016 guidance entitled, ``Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus; Guidance for Industry'' and the March 2016 guidance entitled, ``Questions and Answers Regarding `Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus: Guidance for Industry' '' no later than 12 weeks after the date of the issuance of this guidance. Implementation of the guidance will be immediate for blood establishments that collect Whole Blood and blood components in States and territories with local transmission of ZIKV by mosquitos, and will be phased in over 4 to 12 weeks in other States and territories using a tiered, risk-based approach. Blood establishments should follow the recommendations in the February 2016 guidance until they fully implement the recommendations in the guidance document currently being issued. ZIKV is an arbovirus from the Flaviviridae family, genus Flavivirus. It is transmitted to humans primarily by the Aedes aegypti mosquito, but it may also be transmitted by the Aedes albopictus mosquito. The global ZIKV epidemic expanded in the region of the Americas by early [[Page 60007]] 2015 when the first local transmission was reported in Brazil. Local transmission of ZIKV has also been reported in areas outside of the Americas, including the Pacific Islands of Samoa, American Samoa, Marshall Islands and Tonga, and Cape Verde in Africa, and there are now at least 50 countries and territories worldwide with active local transmission of the virus. The first local transmission of ZIKV in the United States was reported from Puerto Rico in December 2015, and soon thereafter local transmission was also reported in American Samoa and the U.S. Virgin Islands. In July 2016, the first cases of local transmission of ZIKV occurring in the continental United States were reported from Miami- Dade County in Florida. The possibility of further geographic spread of ZIKV exists in regions where the Aedes aegypti, and possibly the Aedes albopictus, mosquito is present. In January 2016, ZIKV disease was added to the list of nationally notifiable conditions in the United States as a subtype of Arboviral diseases. The most common ZIKV disease symptoms include fever, arthralgia, maculopapular rash, and conjunctivitis. In addition, neurological manifestations and congenital anomalies have been associated with ZIKV disease outbreaks. ZIKV infection has been associated with Guillain- Barr[eacute] syndrome. ZIKV infection during pregnancy is a cause of microcephaly and other serious fetal brain anomalies. Other problems have been detected in pregnancies and among fetuses and infants infected with ZIKV before birth, such as miscarriage, stillbirth, absent or poorly developed brain structures, defects of the eye, hearing deficits, and impaired growth; however, the full clinical spectrum of the effects of ZIKV infection during pregnancy is not yet known. FDA has identified ZIKV as a transfusion-transmitted infection under Sec. 630.3(l) and RTTI under Sec. 630.3(h)(2). This determination is based on the severity of the disease, risk of transfusion-transmission by blood and blood components, the availability of appropriate screening measures, and significant incidence and prevalence affecting the potential donor population. The guidance recommends that blood establishments test all donations collected in the United States and its territories with an investigational individual donor nucleic acid test (ID-NAT) for ZIKV under an investigational new drug application (IND), or when available, a licensed test. Alternatively, blood establishments may implement pathogen reduction technology for platelets and plasma using an FDA- approved pathogen reduction device as specified in the Instructions for Use of the device. If an FDA-approved pathogen reduction device becomes available for Whole Blood or red blood cells, blood establishments may implement pathogen reduction technology for such products rather than testing the donations. Blood establishments implementing these measures may discontinue providing donor educational material with respect to ZIKV and screening donors for ZIKV risk factors such as travel history and deferring them as previously recommended in the February 2016 guidance. Under 21 CFR 630.10(a), if a donor volunteers a recent history of ZIKV infection, a blood establishment must not collect blood or blood components from that donor. For such donors, the guidance recommends a deferral period of 120 days after a positive viral test or the resolution of symptoms, whichever timeframe is longer. FDA recommends that blood establishments implement the recommendations in the guidance as follows: (1) Blood establishments that collect Whole Blood and blood components in U.S. States and territories with one or more reported locally acquired mosquito-borne cases of ZIKV should implement the recommendations immediately. Blood establishments should cease blood collection until testing or the use of pathogen reduction technology is implemented, consistent with the recommendations in the guidance. As of the date of issuance of the guidance, the recommendations applies to blood establishments that collect Whole Blood and blood components in Florida and Puerto Rico; (2) because of their proximity to areas with locally acquired mosquito- borne cases of ZIKV or because of other epidemiological linkage to ZIKV, such as the number of travel-associated cases reported in a State, blood establishments that collect Whole Blood and blood components in Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina, and Texas should implement the recommendations as soon as feasible, but not later than 4 weeks after the guidance issue date; and (3) blood establishments that collect Whole Blood and blood components in all other States and territories should implement the recommendations as soon as feasible, but not later than 12 weeks after the date of the issuance of this guidance. 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. The guidance represents the current thinking of FDA on ``Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components.'' 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. 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 601.12 have been approved under OMB control number 0910-0338; the collections of information in 21 CFR 606.100(b) and 606.160(b)(1) have been approved under OMB control number 0910-0795; and the collections of information in 21 CFR 606.122 and 630.30 have been approved under OMB control number 0910-0116. III. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: August 25, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-20914 Filed 8-30-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 169 / Wednesday, August 31, 2016 / Notices 60005
accordance with 21 CFR 10.20 and other tobacco product authority to cigars, DEPARTMENT OF HEALTH AND
applicable disclosure law. For more among other products (81 FR 28973). HUMAN SERVICES
information about FDA’s posting of Among the requirements that now apply
comments to public dockets, see 80 FR to cigars are health warning statements Food and Drug Administration
56469, September 18, 2015, or access prescribed under section 906(d) of the [Docket No. FDA–2016–D–0545]
the information at: http://www.fda.gov/ FD&C Act (21 U.S.C. 387f(d)), which
regulatoryinformation/dockets/ permits restrictions on the sale and Revised Recommendations for
default.htm. distribution of tobacco products that are Reducing the Risk of Zika Virus
Docket: For access to the docket to ‘‘appropriate for the protection of public Transmission by Blood and Blood
read background documents or the health.’’ The regulation specifies the Components; Guidance for Industry;
electronic and written/paper comments health warning statements to be Availability
received, go to http://
displayed and also requires the AGENCY: Food and Drug Administration,
www.regulations.gov and insert the
submission of warning plans that HHS.
docket number, found in brackets in the
provide for the random, equal display ACTION: Notice of availability.
heading of this document, into the
‘‘Search’’ box and follow the prompts and random distribution of the
statements on cigar packaging and SUMMARY: The Food and Drug
and/or go to the Division of Dockets Administration (FDA or Agency) is
Management, 5630 Fishers Lane, Rm. advertising.
announcing the availability of a
1061, Rockville, MD 20852. The draft guidance discusses the document entitled ‘‘Revised
Submit written requests for single regulatory requirements to submit Recommendations for Reducing the Risk
copies of this guidance to the Center for warning plans, who submits a warning of Zika Virus Transmission by Blood
Tobacco Products, Food and Drug plan, the scope of a warning plan, when and Blood Components; Guidance for
Administration, Document Control to submit a warning plan, what Industry.’’ The guidance document is
Center, Bldg. 71, Rm. G335, 10903 New information should be submitted in a notifying blood establishments that
Hampshire Ave., Silver Spring, MD warning plan, where to submit a collect Whole Blood and blood
20993–0002. Send one self-addressed warning plan, and what approval of a components, that FDA has determined
adhesive label to assist that office in warning plan means. Zika virus (ZIKV) to be a relevant
processing your request or include a fax transfusion-transmitted infection (RTTI)
number to which the guidance II. Significance of Draft Guidance and provides FDA’s assessment. The
document may be sent. See the guidance also provides
SUPPLEMENTARY INFORMATION section for
FDA is issuing this draft guidance
recommendations to reduce the risk of
information on electronic access to the consistent with FDA’s good guidance
transmission of ZIKV by Whole Blood
guidance. practices regulation (21 CFR 10.115).
and blood components. The guidance
FOR FURTHER INFORMATION CONTACT:
The draft guidance, when finalized, will applies to the collection of Whole Blood
Deirdre Jurand, Center for Tobacco represent the current thinking of FDA and blood components. The guidance
Products, Food and Drug on cigar warning plans. It does not does not apply to the collection of
Administration, 10903 New Hampshire establish any rights for any person and Source Plasma. The guidance
Ave., Document Control Center, Bldg. is not binding on FDA or the public. supersedes the February 2016 document
71, Rm. G335, 10903 New Hampshire You can use an alternative approach if entitled, ‘‘Recommendations for Donor
Ave., Silver Spring, MD 20993–0002, 1– it satisfies the requirements of the Screening, Deferral, and Product
877–287–1373, AskCTP@fda.hhs.gov. applicable statutes and regulations. Management to Reduce the Risk of
SUPPLEMENTARY INFORMATION: Transfusion-Transmission of Zika Virus:
III. Paperwork Reduction Act of 1995
Guidance for Industry’’ (February 2016
I. Background guidance), and the March 2016
This draft guidance also refers to
FDA is announcing the availability of previously approved collections of document entitled, ‘‘Questions and
a draft guidance for industry entitled information found in FDA regulations. Answers Regarding ‘Recommendations
‘‘Submission of Warning Plans for The collections of information in 21 for Donor Screening, Deferral, and
Cigars.’’ CFR part 1143 have been approved Product Management to Reduce the Risk
On June 22, 2009, the President under OMB control number 0910–0768. of Transfusion-Transmission of Zika
signed the Family Smoking Prevention Virus: Guidance for Industry’ ’’ no later
and Tobacco Control Act (Tobacco IV. Electronic Access than 12 weeks after the date of the
Control Act) (Pub. L. 111–31) into law. issuance of this guidance.
The Tobacco Control Act granted FDA Persons with access to the Internet Implementation of the guidance will be
important new authority to regulate the may obtain an electronic version of the immediate for blood establishments that
manufacture, marketing, and guidance at either http:// collect Whole Blood and blood
distribution of cigarettes, cigarette www.regulations.gov or http:// components in States and territories
tobacco, roll-your-own tobacco (RYO), www.fda.gov/TobaccoProducts/ with local transmission of ZIKV by
and smokeless tobacco products to Labeling/RulesRegulationsGuidance/ mosquitos, and will be phased in over
protect the public health and to reduce default.htm. 4 to 12 weeks in other States and
tobacco use by minors. Dated: August 25, 2016. territories using a tiered, risk-based
The Tobacco Control Act also gave approach. Blood establishments should
mstockstill on DSK3G9T082PROD with NOTICES
Leslie Kux,
FDA the authority to issue a regulation follow the recommendations in the
Associate Commissioner for Policy. February 2016 guidance until the
deeming all other products that meet the
statutory definition of a tobacco product [FR Doc. 2016–20913 Filed 8–30–16; 8:45 am] recommendations in the guidance
as subject to FDA regulatory authority BILLING CODE 4164–01–P document have been fully implemented.
(‘‘deeming’’) (section 901(b) of the FD&C DATES: The Agency is soliciting public
Act (21 U.S.C. 387a)). On May 10, 2016, comment, but is implementing this
FDA issued that rule, extending FDA’s guidance immediately because the
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![Federal Register / Vol. 81, No. 169 / Wednesday, August 31, 2016 / Notices 60007
2015 when the first local transmission platelets and plasma using an FDA- This guidance is being issued
was reported in Brazil. Local approved pathogen reduction device as consistent with FDA’s good guidance
transmission of ZIKV has also been specified in the Instructions for Use of practices regulation (21 CFR 10.115).
reported in areas outside of the the device. If an FDA-approved FDA is issuing this guidance for
Americas, including the Pacific Islands pathogen reduction device becomes immediate implementation in
of Samoa, American Samoa, Marshall available for Whole Blood or red blood accordance with 21 CFR 10.115(g)(2)
Islands and Tonga, and Cape Verde in cells, blood establishments may without initially seeking prior comment
Africa, and there are now at least 50 implement pathogen reduction because the Agency has determined that
countries and territories worldwide technology for such products rather prior public participation is not feasible
with active local transmission of the than testing the donations. Blood or appropriate. The guidance represents
virus. establishments implementing these the current thinking of FDA on ‘‘Revised
The first local transmission of ZIKV in measures may discontinue providing Recommendations for Reducing the Risk
the United States was reported from donor educational material with respect of Zika Virus Transmission by Blood
Puerto Rico in December 2015, and soon to ZIKV and screening donors for ZIKV and Blood Components.’’ It does not
thereafter local transmission was also risk factors such as travel history and establish any rights for any person and
reported in American Samoa and the deferring them as previously is not binding on FDA or the public.
U.S. Virgin Islands. In July 2016, the recommended in the February 2016 You can use an alternative approach if
first cases of local transmission of ZIKV guidance. Under 21 CFR 630.10(a), if a it satisfies the requirements of the
occurring in the continental United donor volunteers a recent history of applicable statutes and regulations.
States were reported from Miami-Dade ZIKV infection, a blood establishment
County in Florida. The possibility of II. Paperwork Reduction Act of 1995
must not collect blood or blood
further geographic spread of ZIKV exists components from that donor. For such This guidance refers to previously
in regions where the Aedes aegypti, and donors, the guidance recommends a approved collections of information
possibly the Aedes albopictus, mosquito deferral period of 120 days after a found in FDA regulations. These
is present. In January 2016, ZIKV positive viral test or the resolution of collections of information are subject to
disease was added to the list of symptoms, whichever timeframe is review by the Office of Management and
nationally notifiable conditions in the longer. Budget (OMB) under the Paperwork
United States as a subtype of Arboviral Reduction Act of 1995 (44 U.S.C. 3501–
FDA recommends that blood
diseases. 3520). The collections of information in
The most common ZIKV disease establishments implement the
recommendations in the guidance as 21 CFR 601.12 have been approved
symptoms include fever, arthralgia, under OMB control number 0910–0338;
maculopapular rash, and conjunctivitis. follows: (1) Blood establishments that
collect Whole Blood and blood the collections of information in 21 CFR
In addition, neurological manifestations 606.100(b) and 606.160(b)(1) have been
and congenital anomalies have been components in U.S. States and
territories with one or more reported approved under OMB control number
associated with ZIKV disease outbreaks. 0910–0795; and the collections of
ZIKV infection has been associated with locally acquired mosquito-borne cases
of ZIKV should implement the information in 21 CFR 606.122 and
Guillain-Barré syndrome. ZIKV 630.30 have been approved under OMB
infection during pregnancy is a cause of recommendations immediately. Blood
establishments should cease blood control number 0910–0116.
microcephaly and other serious fetal
brain anomalies. Other problems have collection until testing or the use of III. Electronic Access
been detected in pregnancies and among pathogen reduction technology is Persons with access to the Internet
fetuses and infants infected with ZIKV implemented, consistent with the may obtain the guidance at either http://
before birth, such as miscarriage, recommendations in the guidance. As of www.fda.gov/BiologicsBloodVaccines/
stillbirth, absent or poorly developed the date of issuance of the guidance, the GuidanceComplianceRegulatory
brain structures, defects of the eye, recommendations applies to blood Information/Guidances/default.htm or
hearing deficits, and impaired growth; establishments that collect Whole Blood http://www.regulations.gov.
however, the full clinical spectrum of and blood components in Florida and
Puerto Rico; (2) because of their Dated: August 25, 2016.
the effects of ZIKV infection during
proximity to areas with locally acquired Leslie Kux,
pregnancy is not yet known.
FDA has identified ZIKV as a mosquito-borne cases of ZIKV or Associate Commissioner for Policy.
transfusion-transmitted infection under because of other epidemiological [FR Doc. 2016–20914 Filed 8–30–16; 8:45 am]
§ 630.3(l) and RTTI under § 630.3(h)(2). linkage to ZIKV, such as the number of BILLING CODE 4164–01–P
This determination is based on the travel-associated cases reported in a
severity of the disease, risk of State, blood establishments that collect
transfusion-transmission by blood and Whole Blood and blood components in DEPARTMENT OF HEALTH AND
blood components, the availability of Alabama, Arizona, California, Georgia, HUMAN SERVICES
appropriate screening measures, and Hawaii, Louisiana, Mississippi, New
Mexico, New York, South Carolina, and Health Resources and Services
significant incidence and prevalence
Texas should implement the Administration
affecting the potential donor population.
The guidance recommends that blood recommendations as soon as feasible, National Advisory Committee on Rural
establishments test all donations but not later than 4 weeks after the Health and Human Services; Notice of
collected in the United States and its guidance issue date; and (3) blood
mstockstill on DSK3G9T082PROD with NOTICES
Meeting
territories with an investigational establishments that collect Whole Blood
individual donor nucleic acid test (ID– and blood components in all other In accordance with Section 10(a)(2) of
NAT) for ZIKV under an investigational States and territories should implement the Federal Advisory Committee Act
new drug application (IND), or when the recommendations as soon as (Pub. L. 92–463), notice is hereby given
available, a licensed test. Alternatively, feasible, but not later than 12 weeks of the following meeting:
blood establishments may implement after the date of the issuance of this NAME: National Advisory Committee on
pathogen reduction technology for guidance. Rural Health and Human Services.
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Document Created: 2018-02-02 12:15:19
Document Modified: 2018-02-02 12:15:19
| 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 Agency is soliciting public comment, but is implementing this guidance immediately because the Agency has determined that prior public participation is not feasible or appropriate. Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Jonathan McKnight, 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 | 81 FR 60005 |
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