82 FR 50147 - Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments; Reopening of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 208 (October 30, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 208 (October 30, 2017)
| Page Range | 50147-50148 | |
| FR Document | 2017-23498 |
[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)] [Notices] [Pages 50147-50148] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23498] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4180] Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of the comment period. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or the Agency) is reopening the comment period provided in the notice entitled ``Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments,'' published in the Federal Register of July 25, 2017 (82 FR 34531). That notice announced the public workshop to be held on October 10, 2017, and requested comments by October 18, 2017. The Agency is taking this action to allow interested parties additional time to submit comments. DATES: FDA is reopening the comment period for the public workshop ``Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments'' published on July 25, 2017 (82 FR 34531). Submit either electronic or written comments on this public workshop by December 14, 2017. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 14, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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): 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-2017-N-4180 for ``Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments; Reopening of Comment Period.'' Received comments, those filed in a timely manner (see ADDRESSES), 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 [[Page 50148]] 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. FOR FURTHER INFORMATION CONTACT: Francisco Vicenty, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 3426, Silver Spring, MD 20993, 301-796- 5577, email: [email protected]. SUPPLEMENTARY INFORMATION: In the Federal Register of July 25, 2017 (82 FR 34531), FDA published a notice announcing the public workshop entitled ``Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments'' with an 85-day comment period to request comments. The public workshop was held on October 10, 2017. FDA is reopening the comment period for the public workshop until December 14, 2017. The Agency believes that this will allow adequate time for interested persons to submit comments without significantly delaying the action by the Agency. Dated: October 24, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-23498 Filed 10-27-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 50147
easily and efficiently elicit and review surveys being misrouted within the following measures: Post-fellowship
program feedback. The online voluntary Agency mail system. The information employment (e.g., employment type);
survey will assist the Agency in gathered by the survey will be used to number of awards; number of
promoting and protecting the public gain insights into, and to document, contributions while a CFP fellow (e.g.,
health by encouraging outside persons impacts that the CFP has had and is number of publications, guidance
to share their experience with the FDA having on former CFP fellows and documents authored or co-authored);
while a Commissioner’s Fellow. The contributions and impacts that the and contributions in their field (e.g., list
process will reduce the time and cost of former fellows are making in their of publications).
submitting written documentation to the current work. The voluntary surveys FDA estimates the burden of this
Agency and lessen the likelihood of include questions to assess the collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Fellowship Program Survey ................................................. 35 1 35 * 0.50 17.5
1 There are no capital costs or operating maintenance costs associated with this collection of information.
* 30 minutes.
FDA based these estimates on the Manufacturing and Product Quality • If you want to submit a comment
number of fellows who have graduated Program; Public Workshop; Request for with confidential information that you
and left the Agency over the past 5 Comments’’ published on July 25, 2017 do not wish to be made available to the
years. (82 FR 34531). Submit either electronic public, submit the comment as a
Dated: October 24, 2017. or written comments on this public written/paper submission and in the
workshop by December 14, 2017. manner detailed (see ‘‘Written/Paper
Anna K. Abram,
Submissions’’ and ‘‘Instructions’’).
Deputy Commissioner for Policy, Planning, ADDRESSES: You may submit comments
Legislation, and Analysis. as follows. Please note that late, Written/Paper Submissions
[FR Doc. 2017–23515 Filed 10–27–17; 8:45 am] untimely filed comments will not be Submit written/paper submissions as
BILLING CODE 4164–01–P considered. Electronic comments must follows:
be submitted on or before December 14, • Mail/Hand delivery/Courier (for
2017. The https://www.regulations.gov written/paper submissions): Dockets
DEPARTMENT OF HEALTH AND electronic filing system will accept Management Staff (HFA–305), Food and
HUMAN SERVICES comments until midnight Eastern Time Drug Administration, 5630 Fishers
at the end of December 14, 2017. Lane, Rm. 1061, Rockville, MD 20852.
Food and Drug Administration Comments received by mail/hand • For written/paper comments
[Docket No. FDA–2017–N–4180] delivery/courier (for written/paper submitted to the Dockets Management
submissions) will be considered timely Staff, FDA will post your comment, as
Voluntary Medical Device if they are postmarked or the delivery well as any attachments, except for
Manufacturing and Product Quality service acceptance receipt is on or information submitted, marked and
Program; Public Workshop; Request before that date. identified, as confidential, if submitted
for Comments; Reopening of Comment as detailed in ‘‘Instructions.’’
Period Electronic Submissions Instructions: All submissions received
must include the Docket No. FDA–
AGENCY: Food and Drug Administration, Submit electronic comments in the
2017–N–4180 for ‘‘Voluntary Medical
HHS. following way:
Device Manufacturing and Product
Notice; reopening of the
ACTION: • Federal eRulemaking Portal: Quality Program; Public Workshop;
comment period. https://www.regulations.gov. Follow the Request for Comments; Reopening of
instructions for submitting comments. Comment Period.’’ Received comments,
SUMMARY: The Food and Drug Comments submitted electronically, those filed in a timely manner (see
Administration (FDA or the Agency) is including attachments, to https:// ADDRESSES), will be placed in the docket
reopening the comment period provided www.regulations.gov will be posted to and, except for those submitted as
in the notice entitled ‘‘Voluntary the docket unchanged. Because your ‘‘Confidential Submissions,’’ publicly
Medical Device Manufacturing and comment will be made public, you are viewable at https://www.regulations.gov
Product Quality Program; Public solely responsible for ensuring that your or at the Dockets Management Staff
Workshop; Request for Comments,’’ comment does not include any between 9 a.m. and 4 p.m., Monday
published in the Federal Register of confidential information that you or a through Friday.
July 25, 2017 (82 FR 34531). That notice third party may not wish to be posted, • Confidential Submissions—To
announced the public workshop to be such as medical information, your or submit a comment with confidential
held on October 10, 2017, and requested anyone else’s Social Security number, or information that you do not wish to be
sradovich on DSK3GMQ082PROD with NOTICES
comments by October 18, 2017. The confidential business information, such made publicly available, submit your
Agency is taking this action to allow as a manufacturing process. Please note comments only as a written/paper
interested parties additional time to that if you include your name, contact submission. You should submit two
submit comments. information, or other information that copies total. One copy will include the
DATES: FDA is reopening the comment identifies you in the body of your information you claim to be confidential
period for the public workshop comments, that information will be with a heading or cover note that states
‘‘Voluntary Medical Device posted on https://www.regulations.gov. ‘‘THIS DOCUMENT CONTAINS
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![50148 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices
CONFIDENTIAL INFORMATION’’. The Dated: October 24, 2017. as to eligibility for, and amount of,
Agency will review this copy, including Anna K. Abram, compensation.
the claimed confidential information, in Deputy Commissioner for Policy, Planning, A petition may be filed with respect
its consideration of comments. The Legislation, and Analysis. to injuries, disabilities, illnesses,
second copy, which will have the [FR Doc. 2017–23498 Filed 10–27–17; 8:45 am] conditions, and deaths resulting from
claimed confidential information BILLING CODE 4164–01–P
vaccines described in the Vaccine Injury
redacted/blacked out, will be available Table (the table) set forth at 42 CFR
for public viewing and posted on 100.3. This table lists for each covered
DEPARTMENT OF HEALTH AND childhood vaccine the conditions that
https://www.regulations.gov. Submit
HUMAN SERVICES may lead to compensation and, for each
both copies to the Dockets Management
condition, the time period for
Staff. If you do not wish your name and Health Resources and Services occurrence of the first symptom or
contact information to be made publicly Administration manifestation of onset or of significant
available, you can provide this aggravation after vaccine
information on the cover sheet and not National Vaccine Injury Compensation administration. Compensation may also
in the body of your comments and you Program; List of Petitions Received be awarded for conditions not listed in
must identify this information as the table and for conditions that are
‘‘confidential.’’ Any information marked AGENCY: Health Resources and Services manifested outside the time periods
as ‘‘confidential’’ will not be disclosed Administration (HRSA), Department of specified in the Table, but only if the
except in accordance with 21 CFR 10.20 Health and Human Services (HHS). petitioner shows that the condition was
and other applicable disclosure law. For ACTION: Notice. caused by one of the listed vaccines.
more information about FDA’s posting Section 2112(b)(2) of the PHS Act, 42
of comments to public dockets, see 80 SUMMARY: HRSA is publishing this U.S.C. 300aa–12(b)(2), requires that
notice of petitions received under the ‘‘[w]ithin 30 days after the Secretary
FR 56469, September 18, 2015, or access
National Vaccine Injury Compensation receives service of any petition filed
the information at: https://www.gpo.gov/
Program (the program), as required by under section 2111 the Secretary shall
fdsys/pkg/FR-2015-09-18/pdf/2015-
the Public Health Service (PHS) Act, as publish notice of such petition in the
23389.pdf. amended. While the Secretary of HHS is Federal Register.’’ Set forth below is a
Docket: For access to the docket to named as the respondent in all list of petitions received by HRSA on
read background documents or the proceedings brought by the filing of September 1, 2017, through September
electronic and written/paper comments petitions for compensation under the 30, 2017. This list provides the name of
received, go to https:// Program, the United States Court of petitioner, city and state of vaccination
www.regulations.gov and insert the Federal Claims is charged by statute (if unknown then city and state of
docket number, found in brackets in the with responsibility for considering and person or attorney filing claim), and
heading of this document, into the acting upon the petitions. case number. In cases where the Court
‘‘Search’’ box and follow the prompts FOR FURTHER INFORMATION CONTACT: For has redacted the name of a petitioner
and/or go to the Dockets Management information about requirements for and/or the case number, the list reflects
Staff, 5630 Fishers Lane, Rm. 1061, filing petitions, and the Program in such redaction.
Rockville, MD 20852. general, contact Lisa L. Reyes, Acting Section 2112(b)(2) also provides that
Clerk, United States Court of Federal the special master ‘‘shall afford all
FOR FURTHER INFORMATION CONTACT: interested persons an opportunity to
Claims, 717 Madison Place NW.,
Francisco Vicenty, Food and Drug Washington, DC 20005, (202) 357–6400. submit relevant, written information’’
Administration, Center for Devices and For information on HRSA’s role in the relating to the following:
Radiological Health, 10903 New Program, contact the Director, National 1. The existence of evidence ‘‘that
Hampshire Ave., Bldg. 66, Rm. 3426, Vaccine Injury Compensation Program, there is not a preponderance of the
Silver Spring, MD 20993, 301–796– 5600 Fishers Lane, Room 08N146B, evidence that the illness, disability,
5577, email: Francisco.Vicenty@ Rockville, MD 20857; (301) 443–6593, injury, condition, or death described in
fda.hhs.gov. or visit our Web site at: http:// the petition is due to factors unrelated
www.hrsa.gov/vaccinecompensation/ to the administration of the vaccine
SUPPLEMENTARY INFORMATION: In the described in the petition,’’ and
index.html.
Federal Register of July 25, 2017 (82 FR 2. Any allegation in a petition that the
34531), FDA published a notice SUPPLEMENTARY INFORMATION: The petitioner either:
announcing the public workshop program provides a system of no-fault a. ‘‘[S]ustained, or had significantly
entitled ‘‘Voluntary Medical Device compensation for certain individuals aggravated, any illness, disability,
Manufacturing and Product Quality who have been injured by specified injury, or condition not set forth in the
Program; Public Workshop; Request for childhood vaccines. Subtitle 2 of Title Vaccine Injury Table but which was
Comments’’ with an 85-day comment XXI of the PHS Act, 42 U.S.C. 300aa– caused by’’ one of the vaccines referred
period to request comments. The public 10 et seq., provides that those seeking to in the Table, or
workshop was held on October 10, compensation are to file a petition with b. ‘‘[S]ustained, or had significantly
2017. FDA is reopening the comment the U.S. Court of Federal Claims and to aggravated, any illness, disability,
serve a copy of the petition on the injury, or condition set forth in the
period for the public workshop until
Secretary of HHS, who is named as the
sradovich on DSK3GMQ082PROD with NOTICES
Vaccine Injury Table the first symptom
December 14, 2017. The Agency
respondent in each proceeding. The or manifestation of the onset or
believes that this will allow adequate Secretary has delegated this significant aggravation of which did not
time for interested persons to submit responsibility under the Program to occur within the time period set forth in
comments without significantly HRSA. The Court is directed by statute the Table but which was caused by a
delaying the action by the Agency. to appoint special masters who take vaccine’’ referred to in the Table.
evidence, conduct hearings as In accordance with Section
appropriate, and make initial decisions 2112(b)(2), all interested persons may
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Document Created: 2017-10-28 00:29:15
Document Modified: 2017-10-28 00:29:15
| 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; reopening of the comment period. | |
| Dates | FDA is reopening the comment period for the public workshop ``Voluntary Medical Device Manufacturing and Product Quality Program; Public Workshop; Request for Comments'' published on July 25, 2017 (82 FR 34531). Submit either electronic or written comments on this public workshop by December 14, 2017. | |
| Contact | Francisco Vicenty, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 3426, Silver Spring, MD 20993, 301-796- 5577, email: Franc[email protected] | |
| FR Citation | 82 FR 50147 |
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