82 FR 3002 - Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 6 (January 10, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 6 (January 10, 2017)
| Page Range | 3002-3004 | |
| FR Document | 2017-00200 |
[Federal Register Volume 82, Number 6 (Tuesday, January 10, 2017)] [Notices] [Pages 3002-3004] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00200] [[Page 3002]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-2175] Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; 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 ``Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry.'' The guidance document notifies blood establishments that FDA has determined Ebola virus to be a transfusion-transmitted infection (TTI) and provides blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, with FDA recommendations for assessing blood donor eligibility, 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 guidance document applies to Ebola virus (species Zaire ebolavirus). The recommendations apply to routine collection of blood and blood components for transfusion or further manufacture, including Source Plasma. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2015. DATES: 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: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): 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 Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; 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 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 https://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 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 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: Jessica T. Walker, 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 ``Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry.'' The guidance document notifies blood establishments that FDA has determined Ebola virus to be a TTI under 21 CFR [[Page 3003]] 630.3(l) because of the severity of the disease and the risk of transmission by blood and blood products. The guidance also provides blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, with FDA recommendations for assessing blood donor eligibility, donor deferral, and blood product management in the event that an outbreak of EVD with widespread transmission occurs 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 was 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 to 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. Although viremia in survivors typically resolves within 21 days of disease onset, infectious virus and viral ribonucleic acid (RNA) has been detected in other body components or fluids (e.g., aqueous humor, semen, and vaginal fluids) for longer periods. For instance, infectious virus and viral RNA have been detected in semen up to 82 and 272 days post-EVD onset, respectively, and a case of sexual transmission of Ebola virus was reported in which the patient was exposed to Ebola virus through sexual contact with a survivor 179 days after likely disease onset. 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. Under 21 CFR 630.10(a) and (f)(1), a donor must be in good health and have 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 of EVD. 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 guidance recommends blood establishments 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 classified by Centers for Disease Control and Prevention (CDC) as having widespread transmission of Ebola virus, blood establishments must update their donor history questionnaire (DHQ), including the full-length and abbreviated DHQ and accompanying materials, to assess donors for a history of Ebola virus infection or disease and travel to, or residence in, an area endemic for Ebola virus. The guidance recommends indefinite deferral of a donor with a history of Ebola virus infection or disease and for a donor who has been a resident of or has travelled to a country with widespread transmission of EVD, FDA recommends that establishments defer a donor for 8 weeks from the time of the donor's departure from that country. The guidance document provides additional recommendations for blood establishments in the event that one or more countries are classified by CDC as having widespread transmission of Ebola virus. For a donor who has had close contact with a person confirmed to have EVD or a person 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 contact. In addition, FDA recommends that establishments defer a donor for 8 weeks after the last sexual contact with a person known to have recovered from EVD, regardless of the time since the person's recovery. FDA also 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 EVD. The 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, notification of consignees, and reporting a biological product deviation to FDA. The guidance also addresses convalescent plasma intended for transfusion. In the Federal Register of December 3, 2015 (80 FR 75681), FDA announced the availability of the draft guidance of the same title dated December 2015. FDA received comments on the draft guidance and those comments were considered as the guidance was finalized. A summary of changes made in the final guidance includes: (1) Notifying blood establishments that FDA has determined Ebola virus to be a TTI under Sec. 630.30(l); (2) providing a recommendation that the donor educational materials instruct donors with a history of EVD to self- defer; (3) adding a recommended timeframe for when blood establishments should discontinue donor questioning after CDC declares there is no longer widespread transmission of Ebola virus; and (4) clarifying certain recommendations on product retrieval, quarantine, and notification of consignees of blood and blood components from donors at risk of Ebola virus infection or disease. In addition, editorial changes were made to improve clarity. The guidance announced in this notice finalizes the draft guidance of the same title dated December 2015. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on recommendations for assessment of blood donor eligibility, donor deferral, and blood product management in response to Ebola virus. 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 part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR 600.14 and 606.171 have been approved under OMB control number 0910- 0458; the collections of information in 21 CFR 601.12 and Form FDA 356h have been approved under OMB control number 0910-0338; the collections of information in 21 CFR 606.160 have been approved under OMB control numbers 0910-0116 and 0910-0795; and the collections of information in 21 [[Page 3004]] CFR 630.10 and 630.40 have been approved under OMB control number 0910- 0795. 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 https://www.regulations.gov. Dated: January 3, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-00200 Filed 1-9-17; 8:45 am] BILLING CODE 4164-01-P
![3002 Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Notices
DEPARTMENT OF HEALTH AND third party may not wish to be posted, both copies to the Division of Dockets
HUMAN SERVICES such as medical information, your or Management. If you do not wish your
anyone else’s Social Security number, or name and contact information to be
Food and Drug Administration confidential business information, such made publicly available, you can
as a manufacturing process. Please note provide this information on the cover
[Docket No. FDA–2014–D–2175]
that if you include your name, contact sheet and not in the body of your
Recommendations for Assessment of information, or other information that comments and you must identify this
Blood Donor Eligibility, Donor Deferral identifies you in the body of your information as ‘‘confidential.’’ Any
and Blood Product Management in comments, that information will be information marked as ‘‘confidential’’
Response to Ebola Virus; Guidance for posted on https://www.regulations.gov. will not be disclosed except in
Industry; Availability • If you want to submit a comment accordance with 21 CFR 10.20 and other
with confidential information that you applicable disclosure law. For more
AGENCY: Food and Drug Administration, do not wish to be made available to the information about FDA’s posting of
HHS. public, submit the comment as a comments to public dockets, see 80 FR
ACTION: Notice of availability. written/paper submission and in the 56469, September 18, 2015, or access
manner detailed (see ‘‘Written/Paper the information at: http://www.fda.gov/
SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’).
regulatoryinformation/dockets/
Administration (FDA or Agency) is Written/Paper Submissions default.htm.
announcing the availability of a
document entitled ‘‘Recommendations Submit written/paper submissions as Docket: For access to the docket to
for Assessment of Blood Donor follows: read background documents or the
Eligibility, Donor Deferral and Blood • Mail/Hand delivery/Courier (for electronic and written/paper comments
Product Management in Response to written/paper submissions): Division of received, go to https://
Ebola Virus; Guidance for Industry.’’ Dockets Management (HFA–305), Food www.regulations.gov and insert the
The guidance document notifies blood and Drug Administration, 5630 Fishers docket number, found in brackets in the
establishments that FDA has determined Lane, Rm. 1061, Rockville, MD 20852. heading of this document, into the
Ebola virus to be a transfusion- • For written/paper comments ‘‘Search’’ box and follow the prompts
transmitted infection (TTI) and provides submitted to the Division of Dockets and/or go to the Division of Dockets
blood establishments that collect blood Management, FDA will post your Management, 5630 Fishers Lane, Rm.
and blood components for transfusion comment, as well as any attachments, 1061, Rockville, MD 20852.
or further manufacture, including except for information submitted,
marked and identified, as confidential, Submit written requests for single
Source Plasma, with FDA copies of the guidance to the Office of
recommendations for assessing blood if submitted as detailed in
‘‘Instructions.’’ Communication, Outreach and
donor eligibility, donor deferral, and Development, Center for Biologics
blood product management in the event Instructions: All submissions received
must include the Docket No. FDA– Evaluation and Research (CBER), Food
that an outbreak of Ebola virus disease and Drug Administration, 10903 New
2014–D–2175 for ‘‘Recommendations
(EVD) with widespread transmission is Hampshire Ave., Bldg. 71, Rm. 3128,
for Assessment of Blood Donor
declared in at least one country. The Silver Spring, MD 20993–0002. Send
Eligibility, Donor Deferral and Blood
guidance document applies to Ebola one self-addressed adhesive label to
Product Management in Response to
virus (species Zaire ebolavirus). The
Ebola Virus; Guidance for Industry.’’ assist the office in processing your
recommendations apply to routine
Received comments will be placed in requests. The guidance may also be
collection of blood and blood
the docket and, except for those obtained by mail by calling CBER at 1–
components for transfusion or further
submitted as ‘‘Confidential 800–835–4709 or 240–402–8010. See
manufacture, including Source Plasma.
Submissions,’’ publicly viewable at the SUPPLEMENTARY INFORMATION section
The guidance announced in this notice
https://www.regulations.gov or at the for electronic access to the guidance
finalizes the draft guidance of the same
Division of Dockets Management document.
title dated December 2015.
between 9 a.m. and 4 p.m., Monday
DATES: Submit either electronic or through Friday. FOR FURTHER INFORMATION CONTACT:
written comments on Agency guidances • Confidential Submissions—To Jessica T. Walker, Center for Biologics
at any time. submit a comment with confidential Evaluation and Research, Food and
ADDRESSES: You may submit comments information that you do not wish to be Drug Administration, 10903 New
as follows: made publicly available, submit your Hampshire Ave., Bldg. 71, Rm. 7301,
comments only as a written/paper Silver Spring, MD 20993–0002, 240–
Electronic Submissions
submission. You should submit two 402–7911.
Submit electronic comments in the copies total. One copy will include the
SUPPLEMENTARY INFORMATION:
following way: information you claim to be confidential
• Federal eRulemaking Portal: with a heading or cover note that states I. Background
https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The FDA is announcing the availability of
a document entitled ‘‘Recommendations
pmangrum on DSK3GDR082PROD with NOTICES
Comments submitted electronically, Agency will review this copy, including
including attachments, to https:// the claimed confidential information, in for Assessment of Blood Donor
www.regulations.gov will be posted to its consideration of comments. The Eligibility, Donor Deferral and Blood
the docket unchanged. Because your second copy, which will have the Product Management in Response to
comment will be made public, you are claimed confidential information Ebola Virus; Guidance for Industry.’’
solely responsible for ensuring that your redacted/blacked out, will be available The guidance document notifies blood
comment does not include any for public viewing and posted on establishments that FDA has determined
confidential information that you or a https://www.regulations.gov. Submit Ebola virus to be a TTI under 21 CFR
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![3004 Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Notices
CFR 630.10 and 630.40 have been instructions for submitting comments. Agency will review this copy, including
approved under OMB control number Comments submitted electronically, the claimed confidential information, in
0910–0795. including attachments, to https:// its consideration of comments. The
www.regulations.gov will be posted to second copy, which will have the
III. Electronic Access
the docket unchanged. Because your claimed confidential information
Persons with access to the Internet comment will be made public, you are redacted/blacked out, will be available
may obtain the guidance at either http:// solely responsible for ensuring that your for public viewing and posted on
www.fda.gov/BiologicsBloodVaccines/ comment does not include any https://www.regulations.gov. Submit
GuidanceComplianceRegulatory confidential information that you or a both copies to the Division of Dockets
Information/Guidances/default.htm or third party may not wish to be posted, Management. If you do not wish your
https://www.regulations.gov. such as medical information, your or name and contact information to be
Dated: January 3, 2017. anyone else’s Social Security number, or made publicly available, you can
Leslie Kux, confidential business information, such provide this information on the cover
as a manufacturing process. Please note sheet and not in the body of your
Associate Commissioner for Policy.
that if you include your name, contact comments and you must identify this
[FR Doc. 2017–00200 Filed 1–9–17; 8:45 am]
information, or other information that information as ‘‘confidential.’’ Any
BILLING CODE 4164–01–P identifies you in the body of your information marked as ‘‘confidential’’
comments, that information will be will not be disclosed except in
posted on https://www.regulations.gov. accordance with 21 CFR 10.20 and other
DEPARTMENT OF HEALTH AND • If you want to submit a comment
HUMAN SERVICES applicable disclosure law. For more
with confidential information that you information about FDA’s posting of
do not wish to be made available to the comments to public dockets, see 80 FR
Food and Drug Administration
public, submit the comment as a 56469, September 18, 2015, or access
[Docket No. FDA–2016–D–4646] written/paper submission and in the the information at: http://www.fda.gov/
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
Annual Reporting by Prescription Drug Submissions’’ and ‘‘Instructions’’).
Wholesale Distributors and Third-Party default.htm.
Written/Paper Submissions Docket: For access to the docket to
Logistics Providers: Questions and
read background documents or the
Answers; Draft Guidance for Industry; Submit written/paper submissions as
electronic and written/paper comments
Availability follows:
received, go to https://
• Mail/Hand delivery/Courier (for
AGENCY: Food and Drug Administration, www.regulations.gov and insert the
written/paper submissions): Division of
HHS. docket number, found in brackets in the
Dockets Management (HFA–305), Food
ACTION: Notice of availability. heading of this document, into the
and Drug Administration, 5630 Fishers
‘‘Search’’ box and follow the prompts
SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments and/or go to the Division of Dockets
Administration (FDA or Agency) is Management, 5630 Fishers Lane, Rm.
submitted to the Division of Dockets
announcing the availability of a draft 1061, Rockville, MD 20852.
Management, FDA will post your
guidance for industry entitled ‘‘Annual Submit written requests for single
comment, as well as any attachments,
Reporting by Prescription Drug copies of the draft guidance to the
except for information submitted,
Wholesale Distributors and Third-Party Division of Drug Information, Center for
marked and identified, as confidential,
Logistics Providers: Questions and Drug Evaluation and Research, Food
if submitted as detailed in
Answers.’’ This draft addresses and Drug Administration, 10001 New
‘‘Instructions.’’
questions about and clarifies FDA’s Instructions: All submissions received Hampshire Ave., Hillandale Building,
expectations for annual reporting to must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993–
FDA by prescription drug wholesale 2016–D–4646 for ‘‘Annual Reporting by 0002; or to the Office of
distributors (wholesale distributors) and Prescription Drug Wholesale Communication, Outreach and
third-party logistics providers (3PLs) as Distributors and Third-Party Logistics Development, Center for Biologics
required under the Federal Food, Drug, Providers: Questions and Answers; Draft Evaluation and Research (CBER), Food
and Cosmetic Act (the FD&C Act) as Guidance for Industry; Availability.’’ and Drug Administration, 10903 New
amended by the Drug Supply Chain Received comments will be placed in Hampshire Ave., Bldg. 71, Rm. 3128,
Security Act (DSCSA). the docket and, except for those Silver Spring, MD 20993–0002. Send
DATES: Although you can comment on submitted as ‘‘Confidential one self-addressed adhesive label to
any guidance at any time (see 21 CFR Submissions,’’ publicly viewable at assist that office in processing your
10.115(g)(5)), to ensure that the Agency https://www.regulations.gov or at the requests. See the SUPPLEMENTARY
considers your comment on this draft Division of Dockets Management INFORMATION section for electronic
guidance before it begins work on the between 9 a.m. and 4 p.m., Monday access to the draft guidance document.
final version of the guidance, submit through Friday. FOR FURTHER INFORMATION CONTACT:
either electronic or written comments • Confidential Submissions—To Office of Compliance, Center for Drug
on the draft guidance by March 13, submit a comment with confidential Evaluation and Research, Food and
2017. information that you do not wish to be Drug Administration, 10903 New
pmangrum on DSK3GDR082PROD with NOTICES
ADDRESSES: You may submit comments made publicly available, submit your Hampshire Ave., Silver Spring, MD
as follows: comments only as a written/paper 20993–0002, 301–796–3130,
submission. You should submit two WDD3PLRequirements@fda.hhs.gov.
Electronic Submissions copies total. One copy will include the SUPPLEMENTARY INFORMATION:
Submit electronic comments in the information you claim to be confidential
following way: with a heading or cover note that states I. Background
• Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS Section 204 of the DSCSA (Title II of
https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The Pub. L. 113–54) amended section 503(e)
VerDate Sep<11>2014 19:05 Jan 09, 2017 Jkt 241001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\10JAN1.SGM 10JAN1](https://thefederalregister.org/doc/82_FR_3008/page/3.svg)
Document Created: 2018-02-01 14:54:02
Document Modified: 2018-02-01 14:54:02
| 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 | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Jessica T. Walker, 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 | 82 FR 3002 |
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