80 FR 75681 - Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 232 (December 3, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 232 (December 3, 2015)
| Page Range | 75681-75683 | |
| FR Document | 2015-30589 |
[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)] [Notices] [Pages 75681-75683] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-30589] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-2175] Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. [[Page 75682]] ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, with FDA recommendations for assessing blood donor suitability, donor deferral, and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission is declared in at least one country. The draft guidance document applies primarily to Ebola virus (species Zaire ebolavirus), but recommendations are expected to apply to other viruses of the Ebolavirus genus such as Sudan virus, Bundibugyo virus, and Ta[iuml] Forest virus. The recommendations would apply to routine collection of blood and blood components for transfusion or further manufacture, including Source Plasma. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 2, 2016. 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 2014-D-2175 for ``Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft 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. FOR FURTHER INFORMATION CONTACT: Paul E. Levine, Jr., 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 draft document entitled ``Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry.'' The draft guidance document provides blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, with FDA recommendations for assessing blood donor suitability, donor deferral, and blood product management in the event that an outbreak of EVD with widespread transmission is declared in at least one country. Ebola virus is a member of the family Filoviridae that can cause severe hemorrhagic fever in humans and non-human primates with historically high morbidity and mortality rates of up to 90 percent. However, in the 2014 outbreak in West Africa, the mortality rate has been markedly lower. In humans, EVD is typically characterized at onset by fever, severe headache, muscle pain and weakness, followed by diarrhea, vomiting, abdominal pain, and sometimes diffuse hemorrhage (bleeding or bruising). In previous outbreaks of EVD, symptoms generally appeared within 21 days and most often within 4-10 days following infection; however, based on mathematical models, symptom onset later than 21 days is estimated as possible in 0.1 to 12 percent of cases. In addition, there have been isolated reports of apparently asymptomatic Ebola virus infection in [[Page 75683]] individuals who had contact with Ebola patients. Transmission of Ebola virus from human to human occurs by direct contact with body fluids (such as blood, urine, stool, saliva, semen, vaginal fluids, or vomit) of symptomatic infected individuals. Therefore, blood and blood products from symptomatic individuals, if they were to donate, would have the potential of transmitting Ebola virus to recipients. Current regulations 21 CFR 640.3(b) and 21 CFR 640.63(b)(3) require that a donor be in good health with a normal temperature at the time of donation. Standard procedures that are in place to assure that the donor feels healthy at the time of donation serve as an effective safeguard against collecting blood or blood components from a donor who seeks to donate after the onset of clinical symptoms. FDA is providing guidance to reduce the risks of collecting blood and blood components from potentially Ebola virus-infected persons during the asymptomatic incubation period before the onset of clinical symptoms, as well as from individuals with a history of Ebola virus infection or disease. The draft guidance permits blood establishments to update their donor educational materials to instruct donors with a history of Ebola virus infection or disease to not donate blood or blood components. In the event that one or more countries is designated as having widespread transmission of Ebola virus, the draft guidance includes recommendations to blood establishments to update their donor history questionnaire (DHQ), including the full-length and abbreviated DHQ and accompanying materials, to assess prospective donors for risk of Ebola virus infection or disease. The draft guidance also includes recommendations to blood establishments to defer indefinitely a blood donor with a history of Ebola virus infection or disease, until more data regarding the persistence of Ebola virus in survivors becomes available. For a donor who in the past 8 weeks has been a resident of or has travelled to a country with widespread transmission of Ebola virus disease, FDA recommends that establishments defer the donor for 8 weeks from the time of the donor's departure from that country. For a donor who has had close contact with a person confirmed or under investigation for Ebola virus infection or disease in whom diagnosis is pending, FDA recommends that establishments defer a donor for 8 weeks after the last close contact that could have resulted in direct contact with body fluids, or 8 weeks after the last sexual contact with a person known to have recovered from Ebola virus disease. In addition, FDA recommends that establishments defer for a period of 8 weeks after exposure a donor who has been notified by a Federal, State, or local public health authority that he or she may have been exposed to a person with Ebola virus disease. The draft guidance includes FDA recommendations on retrieval and quarantine of blood and blood components from a donor later determined to have Ebola virus infection or disease or risk factors for Ebola virus infection or disease, for notification of consignees, and for reporting a biological product deviation to FDA. The draft guidance also addresses convalescent plasma intended for transfusion. The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ``Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry.'' 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 The draft 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 606.160(b)(1)(i), 640.3(a) and 640.63(b)(3) have been approved under OMB control number 0910-0116; the collection of information in 21 CFR 606.171 has been approved under OMB control number 0910-0458. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: November 27, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-30589 Filed 12-2-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices 75681
control number 0938–0685; the CMS– 2. CY 2016 Estimates significant impact on the operations of
855S is approved under OMB control a. Medicare a substantial number of small rural
number 0938–1056. hospitals. This analysis must conform to
Based on CMS data, we estimate that the provisions of section 604 of the
IV. Regulatory Impact Statement in CY 2016 approximately— RFA. For purposes of section 1102(b) of
A. Background • 10,000 newly enrolling institutional the Act, we define a small rural hospital
providers will be subject to and pay an as a hospital that is located outside of
We have examined the impact of this application fee; and
notice as required by Executive Order a Metropolitan Statistical Area for
• 45,000 revalidating institutional Medicare payment regulations and has
12866 on Regulatory Planning and providers will be subject to and pay an
Review (September 30, 1993), Executive fewer than 100 beds. We are not
application fee. preparing an analysis for section 1102(b)
Order 13563 on Improving Regulation Using a figure of 55,000 (10,000 newly
and Regulatory Review (January 18, of the Act because we have determined,
enrolling + 45,000 revalidating) and the Secretary certifies, that this
2011), the Regulatory Flexibility Act institutional providers, we estimate an
(RFA) (September 19, 1980, Pub. L. 96– notice would not have a significant
increase in the cost of the Medicare impact on the operations of a substantial
354), section 1102(b) of the Social application fee requirement in CY 2016
Security Act, section 202 of the number of small rural hospitals.
of $5,585,000 (or (10,000 additional Section 202 of the Unfunded
Unfunded Mandates Reform Act of 1995 newly enrolling or revalidating Mandates Reform Act of 1995 (UMRA)
(March 22, 1995; Pub. L. 104–4), institutional providers × $554) + (45,000 also requires that agencies assess
Executive Order 13132 on Federalism × $1.00) from our CY 2015 projections anticipated costs and benefits before
(August 4, 1999), and the Congressional and as previously described.
Review Act (5 U.S.C. 804(2)). issuing any rule whose mandates
Executive Orders 12866 and 13563 b. Medicaid and CHIP require spending in any 1 year of $100
direct agencies to assess all costs and million in 1995 dollars, updated
Based on CMS and state statistics, we
benefits of available regulatory annually for inflation. In 2015, that
estimate that approximately 30,000
alternatives and, if regulation is threshold is approximately $144
(9,000 newly enrolling + 21,000
necessary, to select regulatory million. The Agency has determined
revalidating) Medicaid and CHIP
approaches that maximize net benefits, that there will be minimal impact from
institutional providers will be subject to
including potential economic, the costs of this notice, as the threshold
an application fee in CY 2016. Using
environmental, public health and safety is not met under the UMRA.
this figure, we project an increase in the
effects, distributive impacts, and equity. Executive Order 13132 establishes
cost of the Medicaid and CHIP
A regulatory impact analysis (RIA) must certain requirements that an agency
application fee requirement in CY 2016
be prepared for major rules with must meet when it promulgates a
of $1,213,973 (or ((562 additional newly
economically significant effects ($100 proposed rule (and subsequent final
enrolling institutional providers + 1,579
million or more in any 1 year). As rule) that imposes substantial direct
additional revalidating institutional
explained in this section of the notice, requirement costs on state and local
providers, or 2,141 total additional
governments, preempts state law, or
we estimate that the total cost of the institutional providers) × $554) + 27,859
otherwise has federalism implications.
increase in the application fee will not × $1.00) from our CY 2015 projections
exceed $100 million. Therefore, this Since this notice does not impose
and as previously described.
notice does not reach the $100 million substantial direct costs on state or local
c. Total governments, the requirements of
economic threshold and is not
considered a major notice. Based on the foregoing, we estimate Executive Order 13132 are not
the total increase in the cost of the applicable.
B. Costs application fee requirement for In accordance with the provisions of
The costs associated with this notice Medicare, Medicaid, and CHIP Executive Order 12866, this notice was
involve the increase in the application providers and suppliers in CY 2016 to reviewed by the Office of Management
fee amount that certain providers and be $6,798,973 ($5,585,000 + $1,213,973) and Budget.
suppliers must pay in CY 2016. from our CY 2015 projections. Dated: November 14, 2015.
The RFA requires agencies to analyze Andrew M. Slavitt,
1. Estimates of Number of Affected options for regulatory relief of small
Institutional Providers in December 5, Acting Administrator, Centers for Medicare
businesses. For purposes of the RFA, & Medicaid Services.
2014 Fee Notice small entities include small businesses, [FR Doc. 2015–30686 Filed 12–2–15; 8:45 am]
In the December 5, 2014 application nonprofit organizations, and small BILLING CODE 4120–01–P
fee notice, we estimated that based on governmental jurisdictions. Most
CMS statistics— hospitals and most other providers and
• 10,000 newly enrolling Medicare suppliers are small entities, either by DEPARTMENT OF HEALTH AND
institutional providers would be subject nonprofit status or by having revenues HUMAN SERVICES
to and pay an application fee in CY of less than $7.5 million to $38.5
2015. million in any 1 year. Individuals and Food and Drug Administration
• 35,000 revalidating Medicare states are not included in the definition
institutional providers would be subject [Docket No. FDA–2014–D–2175]
of a small entity. As we stated in the
to and pay an application fee in CY RIA for the February 2, 2011 final rule Recommendations for Assessment of
Lhorne on DSK5TPTVN1PROD with NOTICES
2015. with comment period (76 FR 5952), we Blood Donor Suitability, Donor Deferral
• 8,438 newly enrolling Medicaid and do not believe that the application fee and Blood Product Management in
CHIP providers would be subject to and will have a significant impact on small Response to Ebola Virus; Draft
pay an application fee in CY 2015. entities. Guidance for Industry; Availability
• 19,421 revalidating Medicaid and In addition, section 1102(b) of the Act
CHIP providers would be subject to and requires us to prepare a regulatory AGENCY: Food and Drug Administration,
pay an application fee in CY 2015. impact analysis if a rule may have a HHS.
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![Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices 75683
individuals who had contact with Ebola a person known to have recovered from Dated: November 27, 2015.
patients. Ebola virus disease. In addition, FDA Leslie Kux,
Transmission of Ebola virus from recommends that establishments defer Associate Commissioner for Policy.
human to human occurs by direct for a period of 8 weeks after exposure [FR Doc. 2015–30589 Filed 12–2–15; 8:45 am]
contact with body fluids (such as blood, a donor who has been notified by a BILLING CODE 4164–01–P
urine, stool, saliva, semen, vaginal Federal, State, or local public health
fluids, or vomit) of symptomatic authority that he or she may have been
infected individuals. Therefore, blood exposed to a person with Ebola virus
and blood products from symptomatic DEPARTMENT OF HOMELAND
disease. SECURITY
individuals, if they were to donate,
would have the potential of transmitting The draft guidance includes FDA
recommendations on retrieval and U.S. Customs and Border Protection
Ebola virus to recipients.
Current regulations 21 CFR 640.3(b) quarantine of blood and blood [1651–0017]
and 21 CFR 640.63(b)(3) require that a components from a donor later
donor be in good health with a normal determined to have Ebola virus Agency Information Collection
temperature at the time of donation. infection or disease or risk factors for Activities: Protest
Standard procedures that are in place to Ebola virus infection or disease, for
assure that the donor feels healthy at the notification of consignees, and for AGENCY: U.S. Customs and Border
time of donation serve as an effective reporting a biological product deviation Protection, Department of Homeland
safeguard against collecting blood or to FDA. The draft guidance also Security.
blood components from a donor who addresses convalescent plasma intended ACTION: 60-Day Notice and request for
seeks to donate after the onset of clinical for transfusion. comments; extension of an existing
symptoms. FDA is providing guidance collection of information.
The draft guidance is being issued
to reduce the risks of collecting blood consistent with FDA’s good guidance
and blood components from potentially SUMMARY: U.S. Customs and Border
practices regulation (21 CFR 10.115). Protection (CBP) of the Department of
Ebola virus-infected persons during the
The draft guidance, when finalized, will Homeland Security will be submitting
asymptomatic incubation period before
represent the current thinking of FDA the following information collection
the onset of clinical symptoms, as well
on ‘‘Recommendations for Assessment request to the Office of Management and
as from individuals with a history of
Ebola virus infection or disease. of Blood Donor Suitability, Donor Budget (OMB) for review and approval
The draft guidance permits blood Deferral and Blood Product in accordance with the Paperwork
establishments to update their donor Management in Response to Ebola Reduction Act: Protest. CBP is
educational materials to instruct donors Virus; Draft Guidance for Industry.’’ It proposing that this information
with a history of Ebola virus infection does not establish any rights for any collection be extended with no change
or disease to not donate blood or blood person and is not binding on FDA or the to the burden hours or to the
components. In the event that one or public. You can use an alternative information collected. This document is
more countries is designated as having approach if it satisfies the requirements published to obtain comments from the
widespread transmission of Ebola virus, of the applicable statutes and public and affected agencies.
the draft guidance includes regulations. DATES: Written comments should be
recommendations to blood received on or before February 1, 2016
II. Paperwork Reduction Act of 1995
establishments to update their donor to be assured of consideration.
history questionnaire (DHQ), including The draft guidance refers to ADDRESSES: Written comments may be
the full-length and abbreviated DHQ previously approved collections of mailed to U.S. Customs and Border
and accompanying materials, to assess information found in FDA regulations. Protection, Attn: Tracey Denning,
prospective donors for risk of Ebola These collections of information are Regulations and Rulings, Office of
virus infection or disease. The draft subject to review by the Office of International Trade, 90 K Street NE.,
guidance also includes Management and Budget (OMB) under 10th Floor, Washington, DC 20229–
recommendations to blood the Paperwork Reduction Act of 1995 1177.
establishments to defer indefinitely a (44 U.S.C. 3501–3520). The collections
blood donor with a history of Ebola FOR FURTHER INFORMATION CONTACT:
of information in 21 CFR 601.12 have Requests for additional information
virus infection or disease, until more
been approved under OMB control should be directed to Tracey Denning,
data regarding the persistence of Ebola
number 0910–0338; the collections of U.S. Customs and Border Protection,
virus in survivors becomes available.
information in 21 CFR 606.160(b)(1)(i), Regulations and Rulings, Office of
For a donor who in the past 8 weeks has
640.3(a) and 640.63(b)(3) have been International Trade, 90 K Street NE.,
been a resident of or has travelled to a
approved under OMB control number 10th Floor, Washington, DC 20229–
country with widespread transmission
of Ebola virus disease, FDA 0910–0116; the collection of 1177, at 202–325–0265.
recommends that establishments defer information in 21 CFR 606.171 has been SUPPLEMENTARY INFORMATION: CBP
the donor for 8 weeks from the time of approved under OMB control number invites the general public and other
the donor’s departure from that country. 0910–0458. Federal agencies to comment on
For a donor who has had close contact III. Electronic Access proposed and/or continuing information
with a person confirmed or under collections pursuant to the Paperwork
Lhorne on DSK5TPTVN1PROD with NOTICES
investigation for Ebola virus infection or Persons with access to the Internet Reduction Act of 1995 (Pub. L. 104–13).
disease in whom diagnosis is pending, may obtain the draft guidance at either The comments should address: (a)
FDA recommends that establishments http://www.fda.gov/ Whether the collection of information is
defer a donor for 8 weeks after the last BiologicsBloodVaccines/Guidance necessary for the proper performance of
close contact that could have resulted in ComplianceRegulatoryInformation/ the functions of the agency, including
direct contact with body fluids, or 8 Guidances/default.htm or http:// whether the information shall have
weeks after the last sexual contact with www.regulations.gov. practical utility; (b) the accuracy of the
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Document Created: 2015-12-14 13:51:50
Document Modified: 2015-12-14 13:51:50
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 2, 2016. | |
| Contact | Paul E. Levine, Jr., 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 | 80 FR 75681 |
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