82 FR 24977 - Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Cosmetic Registration Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 103 (May 31, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 103 (May 31, 2017)
| Page Range | 24977-24980 | |
| FR Document | 2017-11188 |
[Federal Register Volume 82, Number 103 (Wednesday, May 31, 2017)] [Notices] [Pages 24977-24980] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-11188] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0623] Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Cosmetic Registration Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice invites comments on the collection of information associated with our Voluntary Cosmetic Registration Program (VCRP). DATES: Submit either electronic or written comments on the collection of information by July 31, 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 July 31, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 31, 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): 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-2010-N-0623 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Cosmetic Registration Program.'' 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 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: 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 [[Page 24978]] 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: Ila Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Voluntary Cosmetic Registration Program--21 CFR Parts 710 and 720 OMB Control Number 0910-0027--Extension The Federal Food, Drug, and Cosmetic Act (the FD&C Act) provides us with the authority to regulate cosmetic products in the United States. Cosmetic products that are adulterated under section 601 of the FD&C Act (21 U.S.C. 361) or misbranded under section 602 of the FD&C Act (21 U.S.C. 362) may not be distributed in interstate commerce. We have developed the VCRP to assist us in carrying out our responsibility to regulate cosmetics. FDA is revising forms for the VCRP (Forms FDA 2511, 2512, 2512a, and 2514) currently approved under OMB control number 0910-0027, ``Voluntary Cosmetic Registration Program,'' for the following reasons: (1) Modernizing the forms; (2) decreasing burden to filers who complete the forms; and (3) reducing the time it will take FDA to review each submission. In addition, Form FDA 2514 will be eliminated as it duplicates information that is currently located on Form FDA 2512. FDA requests PRA approval for the proposed changes to these forms, and for the elimination of Form FDA 2514. Participation in the VCRP is voluntary under provisions found in sections parts 710 and 720 (21 CFR parts 710 and 720). Participants have the option of submitting information via paper forms or via the online interface. The term ``form'' refers to both the paper form and the online system. Currently, in part 710, we request that establishments that manufacture or package cosmetic products voluntarily register with us using Form FDA 2511 entitled ``Registration of Cosmetic Product Establishment.'' The term ``Form FDA 2511'' refers to both the paper and online versions of the form. The online version of Form FDA 2511 is available on our VCRP Web site at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm. We strongly encourage online registration of Form FDA 2511 because it is faster and more efficient for the filer and the Agency. A registering facility will receive confirmation of online registration, including a registration number by email. The online system also allows for amendments to past submissions. Because registration of cosmetic product establishments is not mandatory, voluntary registration provides FDA with the best information available about the locations, business trade names, and types of activity (manufacturing or packaging) of cosmetic product establishments. We place the registration information in a computer database and use the information to generate mailing lists for distributing regulatory information and for inviting firms to participate in workshops on topics in which they may be interested. Registration is permanent, although we request that respondents submit an amended Form FDA 2511 if any of the originally submitted information changes. Currently, under part 720, FDA requests firms that manufacture, pack, or distribute cosmetics to file with the Agency an ingredient statement for each of their products. Filing of cosmetic product ingredient statements is voluntary. Ingredient statements for new submissions are reported on Form FDA 2512, ``Cosmetic Product Ingredient Statement,'' and on Form FDA 2512a, a continuation form. Amendments to product formulations also are reported on Forms FDA 2512 and FDA 2512a. When a firm discontinues the commercial distribution of a cosmetic, FDA requests that the firm file Form FDA 2514, ``Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation''; however, filers may also notify FDA that they have discontinued a cosmetic product formulation by submitting an amended Form FDA 2512, which would obviate the need for Form FDA 2514. If any of the information submitted on these forms is confidential, the firm may submit a request for confidentiality of a cosmetic ingredient. FDA's proposed changes to the forms through the use of an electronic submission system have been designed to make it easier for participants to provide information to FDA about their products. They also assist participants, through interactive question and response scenarios, to identify submissions that will be ineligible to be accepted in VCRP because they do not meet parts 710 and 720 requirements. The electronic submission system is expected to reduce burden currently associated with the manual identification process for filers and FDA. The rejection rate for ineligible submissions when using the current forms is high: 51 percent for new accounts, 43 percent for Form FDA 2511 registrations, and 7 percent for Form FDA 2512 filings (2010-2016). The revised forms include the addition of links between Forms FDA 2511 and 2512, clarification of what information should be entered onto the forms, additional self-identifying fields, removal of certain duplicative fields, and the deletion of Form FDA 2514. These changes are needed because both VCRP voluntary filer participation and FDA resources required to administer VCRP have increased significantly since 2014 (i.e., increases in new accounts (156 percent), Form FDA 2511 registrations (405 percent), Form FDA 2512 filings (67 percent), and FDA review hours (59 percent) in 2016.) FDA's current process confirms that each submission meets the requirements established in parts 710 and 720 through the use of a manual process for [[Page 24979]] both filers and FDA reviewers that can result in a long waiting period where filers must wait and respond to questions generated by FDA, which may result in a high rejection rate. FDA projects a significant reduction in rejection rates when using the revised forms. Examples of possible burden savings for participants and FDA include: (1) Form FDA 2511 asks filers if they are a manufacturer or packer; however, distributors and retailers have checked these boxes in error when neither applies to them because there are no distributor or retailer checkboxes on Form FDA 2511. Retailers have also filed Form FDA 2512 in error even though only manufacturers, packers, and distributors are permitted to do so. To correct these issues, FDA revised Form FDA 2511 by updating the field that allows filers to indicate the ``TYPE OF ESTABLISHMENT: MANUFACTURER/PACKER/OTHER (Distributor or Retailer)'' and updating the field on Form FDA 2512 allowing the filer to indicate ``WHO IS FILING THIS STATEMENT: MANUFACTURER/PACKER/DISTRIBUTOR/OTHER (Retailer).'' (2) FDA revised Form FDA 2511 and added questions asking, ``Are you the owner or operator of this facility?'' and ``Is the address on this form the location of a cosmetic manufacturing and/or packing facility?'' (3) FDA also revised Form FDA 2512 and added questions asking, ``Is this product currently commercially distributed (annual sales exceed $1,000) in the United States?'', ``PRODUCT WEBSITE'', and ``Attach images of the front and back product labels to this form'' to ensure that only cosmetics in commercial distribution in the United States are filed in the VCRP. (4) FDA linked Forms FDA 2511 and 2512 to reduce burden to filers who create multiple copies of Form FDA 2512 that share the same establishment addresses. (5) FDA clarified the information that should be included on the forms by attaching simplified instructions and a link to VCRP online on Forms FDA 2511, 2512, and 2512a and adding titles and locations of various fields throughout Forms FDA 2511, 2512, and 2512a. We also added self-identifying fields such as phone number, email, and alternative authorized individual to Form FDA 2511 and 2512 to facilitate communication with the filers. (6) We also removed fields that have no modern use or request redundant information in multiple locations. (7) We removed Form FDA 2514 in its entirety due to redundancy. (As noted, filers may notify FDA that they are discontinuing a cosmetic product formulation on Form FDA 2512). FDA's online filing system is available on FDA's VCRP Web site at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm. The online filing system contains the online versions of Forms FDA 2511, 2512, and 2512a. We place cosmetic product filing information in a computer database and use the information when FDA receives inquiries about cosmetics marketed in the United States. Because filing of cosmetic product formulations is not mandatory, voluntary filings with FDA provide us with the best information available about cosmetic products, ingredients, frequency of use, businesses engaged in the manufacture and distribution of cosmetics, and approximate rates of product discontinuance and formula modifications. The information assists our scientists in evaluating reports of adverse events submitted via MedWatch and Field Operators (FACTS). We also use the information in identifying future research projects, to evaluate the levels and safety of certain ingredients in cosmetics. Links to explanations of the revisions to Forms FDA 2511, 2512, and 2512a and instructions are available at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm and entitled ``Voluntary Cosmetic Registration Program.'' We estimate the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR Section or Part Form No. Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Part 710 (registrations)............. FDA 2511 \2\ 934 1 934 0.20 (12 minutes).................. 187 720.1 through 720.4 (new submissions) FDA 2512 \3\ 7,108 1 7,108 0.33 (20 minutes).................. 2,346 720.6 (amendments)................... FDA 2512 4,049 1 4,049 0.17 (10 minutes).................. 688 720.6 (notices of discontinuance).... FDA 2512 95 1 95 0.10 (6 minutes)................... 10 720.8 (requests for confidentiality). ............... 1 1 1 2.................................. 2 ------------------------------------------------------------------------------------------------------------------ Total............................ ............... .............. .............. .............. ................................... 3,233 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ The term ``Form FDA 2511'' refers to both the paper Form FDA 2511 and online Form FDA 2511 in the online system known as the VCRP, which is available at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm. \3\ The term ``Form FDA 2512'' refers to the paper Forms FDA 2512, and 2512a and online Form FDA 2512 in the online system known as the VCRP, which is available at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm. We base our estimate of the total annual responses on paper and online submissions received during calendar year 2016. We base our estimate of the hours per response upon information from cosmetic industry personnel and FDA experience entering data submitted on paper Forms FDA 2511, 2512, and 2512a into the online system. We estimate that, annually, 934 establishments that manufacture or package cosmetic products will each submit 1 registration on Form FDA 2511, for a total of 934 annual responses. Each submission is estimated to take 0.20 hour per response for a total of 186.8 hours, rounded to 187. The number of Form FDA 2511 submissions has increased 405 percent compared to 2014 and we have no indication that this submission rate will stop increasing. We estimate that, annually, firms that manufacture, pack, or distribute cosmetics will file 7,108 ingredient statements for new or amended submissions on Forms FDA 2512 and FDA 2512a. Each submission is estimated to take 0.33 hour per response for a total of 2345.64 hours, rounded to 2,346. We estimate the number of Form FDA 2512 submissions to increase 67 percent compared to 2014 and we have no indication that this submission rate will stop increasing. We estimate that, annually, firms that manufacture, pack, or distribute cosmetics will file 4,049 amendments to [[Page 24980]] product formulations on Forms FDA 2512 and FDA 2512a. Each submission is estimated to take 0.17 hour per response for a total of 688.33 hours, rounded to 688. We estimate that, annually, firms that manufacture, pack, or distribute cosmetics will file 95 notices of discontinuance on Form FDA 2512. Each submission is estimated to take 0.10 hour per response for a total of 9.5 hours, rounded to 10. We estimate that, annually, one firm will file one request for confidentiality. Each such request is estimated to take 2 hours to prepare for a total of 2 hours. Thus, the total estimated hour burden for this information collection is 3,233 hours. Dated: May 25, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-11188 Filed 5-30-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 103 / Wednesday, May 31, 2017 / Notices 24977
Estimated Total Annual Burden 1995 (PRA), Federal Agencies are Dockets Management (HFA–305), Food
Hours: 54,934.99. required to publish notice in the and Drug Administration, 5630 Fishers
In compliance with the requirements Federal Register concerning each Lane, Rm. 1061, Rockville, MD 20852.
of Section 506(c)(2)(A) of the Paperwork proposed collection of information, • For written/paper comments
Reduction Act of 1995, the including each proposed extension of an submitted to the Division of Dockets
Administration for Children and existing collection of information, and Management, FDA will post your
Families is soliciting public comment to allow 60 days for public comment in comment, as well as any attachments,
on the specific aspects of the response to the notice. This notice except for information submitted,
information collection described above. invites comments on the collection of marked and identified, as confidential,
Copies of the proposed collection of information associated with our if submitted as detailed in
information can be obtained and Voluntary Cosmetic Registration ‘‘Instructions.’’
comments may be forwarded by writing Program (VCRP). Instructions: All submissions received
to the Administration for Children and DATES: Submit either electronic or must include the Docket No. FDA–
Families, Office of Planning, Research written comments on the collection of 2010–N–0623 for ‘‘Agency Information
and Evaluation, 330 C Street SW., information by July 31, 2017. Collection Activities; Proposed
Washington, DC 20202; Attn: ACF ADDRESSES: You may submit comments
Collection; Comment Request;
Reports Clearance Officer. Email as follows. Please note that late, Voluntary Cosmetic Registration
address: infocollection@acf.hhs.gov. All untimely filed comments will not be Program.’’ Received comments, those
requests should be identified by the title considered. Electronic comments must filed in a timely manner (see
of the information collection. ADDRESSES), will be placed in the docket
be submitted on or before July 31, 2017.
The Department specifically requests The https://www.regulations.gov and, except for those submitted as
comments on: (a) Whether the proposed electronic filing system will accept ‘‘Confidential Submissions,’’ publicly
collection of information is necessary comments until midnight Eastern Time viewable at https://
for the proper performance of the at the end of July 31, 2017. Comments www.regulations.gov/ or at the Division
functions of the agency, including received by mail/hand delivery/courier of Dockets Management between 9 a.m.
whether the information shall have (for written/paper submissions) will be and 4 p.m., Monday through Friday.
• Confidential Submissions—To
practical utility; (b) the accuracy of the considered timely if they are
submit a comment with confidential
agency’s estimate of the burden of the postmarked or the delivery service
information that you do not wish to be
proposed collection of information; (c) acceptance receipt is on or before that
made publicly available, submit your
the quality, utility, and clarity of the date.
comments only as a written/paper
information to be collected; and (d)
Electronic Submissions submission. You should submit two
ways to minimize the burden
Submit electronic comments in the copies total. One copy will include the
information to be collected; and (d)
following way: information you claim to be confidential
ways to minimize the burden of the
collection of information on • Federal eRulemaking Portal: with a heading or cover note that states
https://www.regulations.gov/. Follow ‘‘THIS DOCUMENT CONTAINS
respondents, including through the use CONFIDENTIAL INFORMATION.’’ The
of automated collection techniques or the instructions for submitting
comments. Comments submitted Agency will review this copy, including
other forms of information technology. the claimed confidential information, in
Consideration will be given to electronically, including attachments, to
https://www.regulations.gov/ will be its consideration of comments. The
comments and suggestions submitted second copy, which will have the
within 60 days of this publication. posted to the docket unchanged.
Because your comment will be made claimed confidential information
Robert Sargis, public, you are solely responsible for redacted/blacked out, will be available
Reports Clearance Officer. ensuring that your comment does not for public viewing and posted on
[FR Doc. 2017–11234 Filed 5–30–17; 8:45 am] include any confidential information https://www.regulations.gov/. Submit
that you or a third party may not wish both copies to the Division of Dockets
BILLING CODE 4184–01–P
to be posted, such as medical Management. If you do not wish your
information, your or anyone else’s name and contact information to be
DEPARTMENT OF HEALTH AND Social Security number, or confidential made publicly available, you can
HUMAN SERVICES business information, such as a provide this information on the cover
manufacturing process. Please note that sheet and not in the body of your
Food and Drug Administration if you include your name, contact comments and you must identify this
information, or other information that information as ‘‘confidential.’’ Any
[Docket No. FDA–2010–N–0623]
identifies you in the body of your information marked as ‘‘confidential’’
Agency Information Collection comments, that information will be will not be disclosed except in
Activities; Proposed Collection; posted on https://www.regulations.gov/. accordance with 21 CFR 10.20 and other
Comment Request; Voluntary • If you want to submit a comment applicable disclosure law. For more
Cosmetic Registration Program 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
AGENCY: Food and Drug Administration, public, submit the comment as a 56469, September 18, 2015, or access
HHS. written/paper submission and in the the information at: https://www.gpo.gov/
ACTION: Notice. manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
nlaroche on DSK30NT082PROD with NOTICES
Submissions’’ and ‘‘Instructions’’). 23389.pdf.
SUMMARY: The Food and Drug Docket: For access to the docket to
Administration (FDA or Agency) is Written/Paper Submissions read background documents or the
announcing an opportunity for public Submit written/paper submissions as electronic and written/paper comments
comment on the proposed collection of follows: received, go to https://
certain information by the Agency. • Mail/Hand delivery/Courier (for www.regulations.gov/ and insert the
Under the Paperwork Reduction Act of written/paper submissions): Division of docket number, found in brackets in the
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![24980 Federal Register / Vol. 82, No. 103 / Wednesday, May 31, 2017 / Notices
product formulations on Forms FDA compensation for certain individuals a. ‘‘[S]ustained, or had significantly
2512 and FDA 2512a. Each submission who have been injured by specified aggravated, any illness, disability,
is estimated to take 0.17 hour per childhood vaccines. Subtitle 2 of Title injury, or condition not set forth in the
response for a total of 688.33 hours, XXI of the PHS Act, 42 U.S.C. 300aa– Vaccine Injury Table but which was
rounded to 688. We estimate that, 10 et seq., provides that those seeking caused by’’ one of the vaccines referred
annually, firms that manufacture, pack, compensation are to file a petition with to in the Table, or
or distribute cosmetics will file 95 the U.S. Court of Federal Claims and to b. ‘‘[S]ustained, or had significantly
notices of discontinuance on Form FDA serve a copy of the petition on the aggravated, any illness, disability,
2512. Each submission is estimated to Secretary of HHS, who is named as the injury, or condition set forth in the
take 0.10 hour per response for a total respondent in each proceeding. The Vaccine Injury Table the first symptom
of 9.5 hours, rounded to 10. We estimate Secretary has delegated this or manifestation of the onset or
that, annually, one firm will file one responsibility under the program to significant aggravation of which did not
request for confidentiality. Each such HRSA. The Court is directed by statute occur within the time period set forth in
request is estimated to take 2 hours to to appoint special masters who take the Table but which was caused by a
prepare for a total of 2 hours. Thus, the evidence, conduct hearings as vaccine’’ referred to in the Table.
total estimated hour burden for this appropriate, and make initial decisions In accordance with Section
information collection is 3,233 hours. as to eligibility for, and amount of, 2112(b)(2), all interested persons may
Dated: May 25, 2017. compensation. submit written information relevant to
Anna K. Abram, A petition may be filed with respect the issues described above in the case of
Deputy Commissioner for Policy, Planning, to injuries, disabilities, illnesses, the petitions listed below. Any person
Legislation, and Analysis. conditions, and deaths resulting from choosing to do so should file an original
[FR Doc. 2017–11188 Filed 5–30–17; 8:45 am] vaccines described in the Vaccine Injury and three (3) copies of the information
BILLING CODE 4164–01–P
Table (the Table) set forth at 42 CFR with the Clerk of the U.S. Court of
100.3. This Table lists for each covered Federal Claims at the address listed
childhood vaccine the conditions that above (under the heading FOR FURTHER
DEPARTMENT OF HEALTH AND may lead to compensation and, for each INFORMATION CONTACT), with a copy to
HUMAN SERVICES condition, the time period for HRSA addressed to Director, Division of
occurrence of the first symptom or Injury Compensation Programs,
Health Resources and Services manifestation of onset or of significant Healthcare Systems Bureau, 5600
Administration aggravation after vaccine Fishers Lane, 08N146B, Rockville, MD
administration. Compensation may also 20857. The Court’s caption (Petitioner’s
National Vaccine Injury Compensation be awarded for conditions not listed in Name v. Secretary of HHS) and the
Program; List of Petitions Received the Table and for conditions that are docket number assigned to the petition
AGENCY: Health Resources and Services manifested outside the time periods should be used as the caption for the
Administration, Department of Health specified in the Table, but only if the written submission. Chapter 35 of title
and Human Services. petitioner shows that the condition was 44, United States Code, related to
ACTION: Notice. caused by one of the listed vaccines. paperwork reduction, does not apply to
Section 2112(b)(2) of the PHS Act, 42 information required for purposes of
SUMMARY: HRSA is publishing this U.S.C. 300aa–12(b)(2), requires that carrying out the program.
notice of petitions received under the ‘‘[w]ithin 30 days after the Secretary Dated: May 19, 2017.
National Vaccine Injury Compensation receives service of any petition filed George Sigounas,
Program (the program), as required by under section 2111 the Secretary shall Administrator.
the Public Health Service (PHS) Act, as publish notice of such petition in the
amended. While the Secretary of HHS is Federal Register.’’ Set forth below is a List of Petitions Filed
named as the respondent in all list of petitions received by HRSA on 1. Anissa E. Rogers on behalf of L. C.,
proceedings brought by the filing of April 1, 2017, through April 30, 2017. Fullerton, California, Court of
petitions for compensation under the This list provides the name of the Federal Claims No: 17–0470V.
program, the United States Court of petitioner, city and state of vaccination 2. John Solak, Binghamton, New York,
Federal Claims is charged by statute (if unknown then city and state of Court of Federal Claims No: 17–
with responsibility for considering and person or attorney filing claim), and 0472V.
acting upon the petitions. case number. In cases where the Court 3. Dolores Justice, Pittsburgh,
FOR FURTHER INFORMATION CONTACT: For has redacted the name of the petitioner Pennsylvania, Court of Federal
information about requirements for and/or the case number, the list reflects Claims No: 17–0476V.
filing petitions, and the program in such redaction. 4. Ruben Abeyta, Flagstaff, Arizona,
general, contact the Acting Clerk of the Section 2112(b)(2) also provides that Court of Federal Claims No: 17–
Court, Lisa L. Reyes, United States Court the special master ‘‘shall afford all 0477V.
of Federal Claims, 717 Madison Place interested persons an opportunity to 5. Hillary Adams, Phoenix, Arizona,
NW., Washington, DC 20005, (202) 357– submit relevant, written information’’ Court of Federal Claims No: 17–
6400. For information on HRSA’s role in relating to the following: 0478V.
the program, contact the Director, 1. The existence of evidence ‘‘that 6. Emma Sullivan, Phoenix, Arizona,
National Vaccine Injury Compensation there is not a preponderance of the Court of Federal Claims No: 17–
nlaroche on DSK30NT082PROD with NOTICES
Program, 5600 Fishers Lane, Room evidence that the illness, disability, 0480V.
08N146B, Rockville, MD 20857; (301) injury, condition, or death described in 7. Joanne Gurney, Fall River,
443–6593, or visit our Web site at: the petition is due to factors unrelated Massachusetts, Court of Federal
http://www.hrsa.gov/vaccine to the administration of the vaccine Claims No: 17–0481V.
compensation/index.html. described in the petition,’’ and 8. Daniel Jenson, Hillsboro, North
SUPPLEMENTARY INFORMATION: The 2. Any allegation in a petition that the Dakota, Court of Federal Claims No:
program provides a system of no-fault petitioner either: 17–0482V.
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Document Created: 2017-05-31 05:59:34
Document Modified: 2017-05-31 05:59:34
| 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 | Submit either electronic or written comments on the collection of information by July 31, 2017. | |
| Contact | Ila Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 82 FR 24977 |
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