82 FR 60747 - Amendment to “Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;” Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 245 (December 22, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 245 (December 22, 2017)
| Page Range | 60747-60749 | |
| FR Document | 2017-27569 |
[Federal Register Volume 82, Number 245 (Friday, December 22, 2017)] [Notices] [Pages 60747-60749] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27569] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0307] Amendment to ``Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;'' Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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 draft document entitled ``Amendment to `Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;' Draft Guidance for Industry.'' The draft guidance document provides blood collection establishments with revised recommendations intended to reduce the possible risk of transmission of variant Creutzfeldt-Jakob Disease (vCJD) by blood and blood products by revising and removing certain recommended deferrals for geographic risk of bovine spongiform encephalopathy (BSE) exposure and recommending deferral for individuals with a history of blood transfusion in Ireland from 1980 to the present. The recommendations apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing into injectable and non-injectable products, including recovered plasma, Source Leukocytes and Source Plasma. The draft guidance, when finalized, will amend the document entitled ``Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry'' updated January 2016 (``2016 vCJD Guidance'') by incorporating into an updated final guidance any new recommendations adopted. All other recommendations in the 2016 vCJD Guidance will remain unchanged. DATES: Submit either electronic or written comments on the draft guidance by March 22, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance 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, 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 [[Page 60748]] 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-2012-D-0307 for ``Amendment to `Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry;' Draft 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 draft 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 draft 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 draft guidance document. FOR FURTHER INFORMATION CONTACT: Melissa Segal, 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 ``Amendment to `Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt- Jakob Disease by Blood and Blood Products; Guidance for Industry;' Draft Guidance for Industry.'' The draft guidance provides blood collection establishments with revised recommendations intended to reduce the possible risk of transmission of vCJD by blood and blood products. The draft guidance, when finalized, will amend FDA's current recommendations by revising and removing certain recommended deferrals for geographic risk of BSE exposure; and recommending deferral for individuals with a history of blood transfusion in Ireland from 1980 to the present. The draft guidance also includes recommendations for blood collection establishments to update their donor history questionnaires (DHQ), including full-length and abbreviated DHQs and accompanying materials, and processes to incorporate the recommendations provided in the guidance, and recommendations for licensed establishments on how to report such changes to FDA. The recommendations apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing into injectable and non-injectable products, including recovered plasma, Source Leukocytes and Source Plasma. While this draft guidance specifically provides revised recommendations to address vCJD risk, we may address Creutzfeldt-Jakob Disease (CJD) risk in future guidance documents. The revised donor deferral recommendations are based on the results of an FDA quantitative risk assessment model. The model was developed to rank the risk of vCJD in different countries, to evaluate risk reduction and donor loss resulting from the current donor deferral policy compared with alternative policies, and to evaluate the potential additional reduction in risk afforded by leukocyte reduction of red blood cells. The model estimated that the United Kingdom, Ireland, and France, the three countries with the highest vCJD risks, contributed 95 percent of the total vCJD risk in the United States. The model also predicted that a revised policy of deferring donors only for time spent in these three countries would maintain a level of blood safety similar to that resulting from current policy, assuming approximately 71.3 to 95 percent of red blood cells currently transfused in the United States are leukocyte reduced. Based on its value in reducing the risk of transfusion-transmitted vCJD and its other medical benefits, FDA continues to consider potential rulemaking that would require leukocyte reduction of red blood cells and platelets intended for transfusion. The draft guidance, when finalized, will amend the 2016 vCJD Guidance. This 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 ``Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products.'' 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 [[Page 60749]] regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This 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 and Form FDA 356h have been approved under OMB control number 0910-0338. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: December 18, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27569 Filed 12-21-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 245 / Friday, December 22, 2017 / Notices 60747
coaching funders or providers, ECE center directors, coaches, teachers, and
FCC providers.
ANNUAL BURDEN ESTIMATES
Annual Number of Average
Total number Annual burden
Instrument number of responses per burden hours
of respondents hours
respondents respondent per response
State coaching informant interview protocol ........................ 45 23 1 1 23
ECE setting eligibility screener ............................................ 173 87 1 0.25 22
Center director survey ......................................................... 60 30 1 0.5 15
Coach survey ....................................................................... 90 45 1 0.5 23
Teacher/FCC provider survey .............................................. 172 86 1 0.58 50
Center director semi-structured interview protocol .............. 12 6 1 1.5 9
Coach semi-structured interview protocol ........................... 12 6 1 1 6
Teacher/FCC provider semi-structured interview protocol .. 12 6 1 1 6
Coach supervisor semi-structured interview protocol .......... 12 6 1 0.5 3
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND Reduce the Possible Risk of
Hours: 157. HUMAN SERVICES Transmission of Creutzfeldt-Jakob
In compliance with the requirements Disease and Variant Creutzfeldt-Jakob
Food and Drug Administration Disease by Blood and Blood Products;
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the [Docket No. FDA–2012–D–0307] Guidance for Industry’’ updated January
2016 (‘‘2016 vCJD Guidance’’) by
Administration for Children and
Amendment to ‘‘Revised Preventive incorporating into an updated final
Families is soliciting public comment
Measures To Reduce the Possible Risk guidance any new recommendations
on the specific aspects of the adopted. All other recommendations in
of Transmission of Creutzfeldt-Jakob
information collection described above. the 2016 vCJD Guidance will remain
Disease and Variant Creutzfeldt-Jakob
Copies of the proposed collection of unchanged.
Disease by Blood and Blood Products;
information can be obtained and
Guidance for Industry;’’ Draft Guidance DATES: Submit either electronic or
comments may be forwarded by writing for Industry; Availability
to the Administration for Children and written comments on the draft guidance
Families, Office of Planning, Research, AGENCY: Food and Drug Administration, by March 22, 2018 to ensure that the
and Evaluation, 330 C Street SW, HHS. Agency considers your comment on this
Washington, DC 20201, Attn: OPRE draft guidance before it begins work on
ACTION: Notice of availability.
the final version of the guidance.
Reports Clearance Officer. Email
address: OPREinfocollection@ SUMMARY: The Food and Drug ADDRESSES: You may submit comments
acf.hhs.gov. All requests should be Administration (FDA or Agency) is on any guidance at any time as follows:
identified by the title of the information announcing the availability of a draft
Electronic Submissions
collection. document entitled ‘‘Amendment to
‘Revised Preventive Measures to Reduce Submit electronic comments in the
The Department specifically requests the Possible Risk of Transmission of following way:
comments on (a) whether the proposed Creutzfeldt-Jakob Disease and Variant • Federal eRulemaking Portal:
collection of information is necessary Creutzfeldt-Jakob Disease by Blood and https://www.regulations.gov. Follow the
for the proper performance of the Blood Products; Guidance for Industry;’ instructions for submitting comments.
functions of the agency, including Draft Guidance for Industry.’’ The draft Comments submitted electronically,
whether the information shall have guidance document provides blood including attachments, to https://
practical utility; (b) the accuracy of the collection establishments with revised www.regulations.gov will be posted to
agency’s estimate of the burden of the recommendations intended to reduce the docket unchanged. Because your
proposed collection of information; (c) the possible risk of transmission of comment will be made public, you are
the quality, utility, and clarity of the variant Creutzfeldt-Jakob Disease (vCJD) solely responsible for ensuring that your
information to be collected; and (d) by blood and blood products by revising comment does not include any
ways to minimize the burden of the and removing certain recommended confidential information that you or a
collection of information on deferrals for geographic risk of bovine third party may not wish to be posted,
respondents, including through the use spongiform encephalopathy (BSE) such as medical information, your or
of automated collection techniques or exposure and recommending deferral anyone else’s Social Security number, or
other forms of information technology. for individuals with a history of blood confidential business information, such
Consideration will be given to transfusion in Ireland from 1980 to the as a manufacturing process. Please note
comments and suggestions submitted present. The recommendations apply to that if you include your name, contact
the collection of Whole Blood and blood information, or other information that
within 60 days of this publication.
components intended for transfusion or identifies you in the body of your
sradovich on DSK3GMQ082PROD with NOTICES
Mary Jones, for use in further manufacturing into comments, that information will be
ACF/OPRE Certifying Officer. injectable and non-injectable products, posted on https://www.regulations.gov.
[FR Doc. 2017–27578 Filed 12–21–17; 8:45 am] including recovered plasma, Source • If you want to submit a comment
Leukocytes and Source Plasma. with confidential information that you
BILLING CODE 4184–22–P
The draft guidance, when finalized, do not wish to be made available to the
will amend the document entitled public, submit the comment as a
‘‘Revised Preventive Measures to written/paper submission and in the
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![Federal Register / Vol. 82, No. 245 / Friday, December 22, 2017 / Notices 60749
regulations. This guidance is not subject transparency, and communication; at FDA. The PEC will be a joint
to Executive Order 12866. providing considerations for endeavor between the CTTI and FDA.
implementing new strategies to enhance The activities of the PEC may inform
II. Paperwork Reduction Act of 1995
patient engagement at FDA; and relevant FDA and CTTI activities. The
This draft guidance refers to proposing new models of collaboration PEC is not intended to advise or
previously approved collections of in which patients and patient advocates otherwise direct the activities of either
information found in FDA regulations. are partners in certain aspects of the organization, and membership will not
These collections of information are medical product development and FDA constitute employment by either
subject to review by the Office of review process. organization.
Management and Budget (OMB) under DATES: Nominations received by 11:59 The Food and Drug Administration
the Paperwork Reduction Act of 1995 p.m. Eastern Time on or before January Safety and Innovation Act (Pub. L. 112–
(44 U.S.C. 3501–3520). The collections 29, 2018, will be given first 144), section 1137, entitled ‘‘Patient
of information in 21 CFR 601.12 and consideration for membership on the Participation in Medical Product
Form FDA 356h have been approved PEC. Nominations received after the Discussions,’’ added section 569C to the
under OMB control number 0910–0338. submission deadline will be retained for Federal Food, Drug, and Cosmetic Act
III. Electronic Access future consideration. (21 U.S.C. 360bbb–8c). This provision
ADDRESSES: All nominations should be directs the Secretary of Health and
Persons with access to the internet Human Services to develop and
may obtain the draft guidance at either submitted to the FDA’s Patient Affairs
Staff in the OMPT. Email nominations implement strategies to solicit the views
https://www.fda.gov/BiologicsBlood of patients during the medical product
Vaccines/GuidanceCompliance are preferred and should be submitted
to PatientEngagementCollaborative@ development process and consider the
RegulatoryInformation/Guidances/ perspectives of patients during
default.htm or https:// fda.hhs.gov. Though not required, it is
appreciated if all nomination materials regulatory discussions. On November 4,
www.regulations.gov. 2014, FDA issued a Federal Register
are compiled into a single PDF file and
Dated: December 18, 2017. attached to the submission email. notice establishing a docket (FDA–
Leslie Kux, Nominations may also be submitted by 2014–N–1698) for public commenters to
Associate Commissioner for Policy. mail or delivery service to Patient submit information related to FDA’s
[FR Doc. 2017–27569 Filed 12–21–17; 8:45 am] Affairs Staff, Office of Medical Products implementation of this provision (79 FR
and Tobacco, Office of the 65410). Upon review of the comments
BILLING CODE 4164–01–P
Commissioner, Food and Drug received, one common theme, among
Administration, 10903 New Hampshire others, included establishing an external
DEPARTMENT OF HEALTH AND Ave., Bldg. 1, Rm. 1316, Silver Spring, group to provide input on patient
HUMAN SERVICES MD 20993. Only complete applications, engagement strategies across FDA’s
as described in section ‘‘IV. Nomination Centers.
Food and Drug Administration Process’’ of this document, will be Recent legislation in both section
considered. 3001 of the 21st Century Cures Act and
[Docket No. FDA–2017–N–6395] section 605 of the Food and Drug
FOR FURTHER INFORMATION CONTACT: Administration Reauthorization Act of
Request for Nominations of Members Andrea Furia-Helms, Office of Medical 2017 supports tools for fostering patient
for the Clinical Trials Transformation Products and Tobacco, Office of the participation in the regulatory process.
Initiative/Food and Drug Commissioner, Food and Drug The purpose of this notice is to
Administration Patient Engagement Administration, 10903 New Hampshire announce that the nomination process
Collaborative Ave., Bldg. 1, Rm. 1316, Silver Spring, for the PEC is now open, and to invite
AGENCY: Food and Drug Administration, MD 20993, 301–796–8455, and encourage nominations by the
HHS. PatientEngagementCollaborative@ submission deadline for appropriately
ACTION: Notice. fda.hhs.gov. qualified individuals. Self-nominations
SUPPLEMENTARY INFORMATION: are accepted.
SUMMARY: The Food and Drug
Administration (FDA or Agency), in I. Background and Purpose II. Criteria for Membership
collaboration with the Clinical Trials The CTTI is a public-private The PEC will include up to 16 diverse
Transformation Initiative (CTTI), is partnership co-founded by FDA and representatives of the patient
requesting nominations of patient Duke University whose mission is to community. Selected members will
advocates interested in participating on develop and drive adoption of practices include the following: (1) Patients who
the Patient Engagement Collaborative that will increase the quality and have personal disease experience; (2)
(PEC). The PEC will be an ongoing, efficiency of clinical trials. FDA and caregivers who support patients, such as
collaborative forum coordinated through CTTI have long involved patients and a parent, child, partner, other family
the Patient Affairs Staff, Office of considered patient perspectives in their member, or friend, and who have
Medical Products and Tobacco (OMPT), work. Furthering the engagement of personal disease experience through
Office of the Commissioner, and will be patients as valued partners across the this caregiver role; and (3)
hosted by CTTI. Through the PEC, the medical product research and representatives from patient groups
patient community and regulators will development continuum requires an who, through their role in the patient
be able to discuss an array of topics group, have direct or indirect disease
sradovich on DSK3GMQ082PROD with NOTICES
open forum for patients and regulators
regarding increasing meaningful patient to discuss and exchange ideas. experience. Please note that for
engagement in medical product The PEC will be an ongoing, purposes of this activity, the term
development and regulatory discussions collaborative forum in which the patient ‘‘caregiver’’ is not intended to include
at FDA. The activities of the PEC may community and regulators will discuss individuals who are engaged in
include, but are not limited to, an array of topics regarding increasing caregiving as health care professionals;
providing diverse perspectives on topics patient engagement in medical product and the term ‘‘patient group’’ is used
such as systematic patient engagement, development and regulatory discussions herein to encompass patient advocacy
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Document Created: 2017-12-22 00:34:37
Document Modified: 2017-12-22 00:34:37
| 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 the draft guidance by March 22, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Melissa Segal, 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 60747 |
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