        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        42 CFR Part 100
        RIN 0906-AB00
        National Vaccine Injury Compensation Program

          AGENCY:
          Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

          ACTION:
          Notice of proposed rulemaking.

          SUMMARY:

          The Secretary has made findings as to intussusceptions that can reasonably be determined in some circumstances to be caused or significantly aggravated by rotavirus vaccines. Based on these findings, the Secretary proposes to amend the Vaccine Injury Table (Table) by regulation. These proposed regulations will apply only for petitions for compensation under the National Vaccine Injury Compensation Program (VICP) filed after the final regulations become effective. The Secretary is seeking public comment on the proposed revisions to the Table.

          DATES:

          Written comments must be submitted on or before January 21, 2014. A public hearing on this proposed rule will be held before the end of the public comment period. A separate notice will be published in the Federal Register to provide the details of this hearing. Subject to consideration of the comments received, the Secretary intends to publish a final regulation.

          ADDRESSES:

          You may submit comments in one of three ways, as listed below. The first is the preferred method. Please submit your comments in only one of these ways to minimize the receipt of duplicate submissions.
          1. Federal eRulemaking Portal. You may submit comments electronically to http://www.regulations.gov. Click on the link “Submit electronic comments on HRSA regulations with an open comment period.” Submit your comments as an attachment to your message or cover letter. (Attachments should be in Microsoft Word or WordPerfect; however, Microsoft Word is preferred).
          2. By regular, express, or overnight mail. You may mail written comments to the following address only: Health Resources and Services Administration, Department of Health and Human Services: Attention: HRSA Regulations Officer, Parklawn Building, Room 14-101, 5600 Fishers Lane, Rockville, MD 20857. Please allow sufficient time for mailed comments to be received before the close of the comment period.
          3. Delivery by hand (in person or by courier). If you prefer, you may deliver your written comments before the close of the comment period to the same address: Parklawn Building, Room 14-101, 5600 Fishers Lane, Rockville, MD 20857. Please call in advance to schedule your arrival with one of our HRSA Regulations Office staff members at telephone number (301) 443-1785. This is not a toll-free number.
          Because of staffing and resource limitations, and to ensure that no comments are misplaced, HRSA cannot accept comments by facsimile (FAX) transmission. In commenting, by any of the above methods, please refer to file code (HRSA #0906-AB00). All comments received on a timely basis will be available for public inspection without charge, including any personal information provided, in Room 14-101 of the Health Resources and Services Administration's offices at 5600 Fishers Lane, Rockville, MD., on Monday through Friday of each week from 8:30 a.m. to 5 p.m. (excluding federal holidays). Phone: (301) 443-1785. This is not a toll-free number.

          FOR FURTHER INFORMATION CONTACT:

          Please visit the National Vaccine Injury Compensation Program's Web site, http://www.hrsa.gov/vaccinecompensation/, or contact Dr. Catherine Shaer, Acting Chief Medical Officer, National Vaccine Injury Compensation Program, Healthcare Systems Bureau, Health Resources and Services Administration, Parklawn Building, Room 11C-26, 5600 Fishers Lane, Rockville, MD 20857. Phone calls can be directed to (855) 266-2427. This is a toll-free number.

        SUPPLEMENTARY INFORMATION:

        Background
        Under Title XXI of the Public Health Service (PHS) Act, individuals who demonstrate a vaccine-related injury or death may receive compensation through the National Vaccine Injury Compensation Program (VICP). To gain entitlement to compensation in the VICP, a petitioner must demonstrate that the injured or deceased individual received a vaccine set forth in the Vaccine Injury Table (a “covered vaccine”) and sustained a vaccine-related injury or death. A petitioner can prove a vaccine-related injury or death in two ways: (1) The petitioner can show that the vaccine recipient suffered an injury listed in the Vaccine Injury Table corresponding with the vaccine received, and that the onset of such injury occurred within the time period specified in the Table (a “Table injury”). As set out in sections 2111(c)(1)(C)(i), 2113(a)(1)(B), and 2114(a) of the PHS Act, a Table injury or death is given the legal presumption that it was caused by the vaccination. (2) If the petitioner cannot demonstrate a Table injury, the petitioner can prevail by proving, by a preponderance of the evidence, that the vaccine caused the injury or death (an “off-Table injury”). In either case, a petitioner must also show that the injury was sufficiently severe by demonstrating that such person suffered the residual effects of the injury for more than 6 months; died from the administration of the vaccine; or that the alleged injury resulted in inpatient hospitalization and surgical intervention. Section 2111(c) of the PHS Act. If the petitioner can prove a Table injury or off-Table injury, the petitioner is entitled to compensation unless it is affirmatively shown by the Secretary that the injury was caused by some factor unrelated to the vaccination.
        Under section 2114(e)(2) of the PHS Act, when the Centers for Disease Control and Prevention (CDC) recommends a vaccine for routine administration to children, the Secretary is required to amend the Vaccine Injury Table to include such vaccine. Coverage becomes effective when an excise tax is imposed on the vaccine. Additionally, the Secretary is authorized to include specific adverse events on the Table with respect to each covered vaccine, including the time period when the first symptoms or manifestations of onset or other significant aggravation of such adverse event may occur. Under section 2114(c) of the PHS Act, the Secretary may make such modifications to the Table by promulgating regulations, with notice and opportunity for a public hearing, and at least 180 days of public comment.
        Coverage for Rotavirus Vaccines on the Vaccine Injury Table
        The general category of rotavirus vaccines was added for coverage under the VICP, effective October 22, 1998. The prerequisites for adding rotavirus vaccines to the VICP were satisfied by the enactment of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999, Pub. L. 105-277 (October 21, 1998), which imposed an excise tax of 75 cents per dose on “any vaccine against rotavirus gastroenteritis,” and the publication of the CDC recommendation of the vaccine for “routine use in children” in the “Morbidity and Mortality Weekly Report” (MMWR), 1999:48 (March 19, 1999).
        When the general category of rotavirus vaccines was added to the Table, it was added with “no condition specified.” 64 FR 40517. In other words, at the time rotavirus vaccines were first included for coverage under the Program, the Secretary had not identified any adverse events to include in the Table. Therefore, individuals who received the rotavirus vaccine did not receive a legal presumption of causation for any claimed injury and were required to prove that the vaccine actually caused the claimed injury.
        History of Rotashield Vaccine

        On August 31, 1998, the Food and Drug Administration (FDA) licensed a live, oral, rhesus-based rotavirus tetravalent vaccine (trade name “Rotashield”) for use in infants between the ages of 6 weeks and 1 year. Distribution of the vaccine began on October 1, 1998. At the time, this was the only U.S.-licensed rotavirus vaccine on the market. Following a review by the Advisory Committee on Immunization Practices (ACIP), the CDC published its rotavirus recommendation in the March 19, 1999, issue of the MMWR (1999:48), calling for doses to be administered at 2, 4, and 6 months of age, with the first dose to be administered between 6 weeks and 6 months. The series was not to be initiated in children who were 7 months of age or older due to an increased rate of febrile (fever) reactions after the first dose among older infants.
        Over the next eight months, the Secretary's Vaccine Adverse Event Reporting System (VAERS) began receiving reports of intussusception (a type of bowel obstruction that occurs when the bowel folds into itself) in infants receiving the Rotashield vaccine after the first dose. Based on an analysis of 15 reports, the CDC, in the July 16, 1999, issue of the MMWR, recommended that health care providers and parents postpone use of this rotavirus vaccine. The CDC undertook additional epidemiological studies to determine if there was a true association between the vaccine and intussusception. Also, at that time, the manufacturer, in consultation with the FDA, voluntarily ceased further distribution of the vaccine. Upon further consideration, and following consultation with CDC officials in preparation for the upcoming ACIP meeting, the manufacturer announced the withdrawal of the Rotashield vaccine (which was still the only U.S.-licensed rotavirus vaccine at that time) from the market on October 15, 1999, and requested the immediate return of all doses of the vaccine.
        At its October 22, 1999, meeting, the ACIP reviewed scientific data from several sources, including a 19-state case-control study which showed a statistically significant rate of intussusception among recipients of the live, oral, rhesus-based rotavirus vaccine in the 2 week period following vaccine administration, with the highest risk period in the 3-14 days after the first dose of vaccine, and a much smaller risk in the same time period after dose two. Beyond 14 days, there did not appear to be more cases than might occur by chance alone. The ACIP concluded that intussusception occurs with significantly increased frequency in the first 14 days following administration of the Rotashield vaccine and withdrew its recommendation for use of this vaccine in infants. The CDC adopted and published the Committee's decision in the November 5, 1999, issue of the MMWR.
        By December 2000, VAERS had received over 100 reports of confirmed intussusception cases, 58 of which had onset within 7 days of vaccine receipt. Of the cases reported, approximately one-half required surgical intervention. Nearly all of the other cases of bowel obstruction were relieved through barium enema, a radiological procedure used to both diagnose and often rectify the telescoped bowel segment, or resolved spontaneously without any intervention. At least one death associated with rotavirus vaccine was reported to VAERS.
        The Secretary reviewed the epidemiological data, and in a notice of proposed rulemaking published on July 13, 2001, the Secretary announced his findings that the condition of intussusception could reasonably be determined in some circumstances to be caused by vaccines containing live, oral, rhesus-based rotavirus (66 FR 36735). Based on those findings, the Secretary proposed to amend the Table by adding the specific category of vaccines containing live, oral, rhesus-based rotavirus as a distinct category, with intussusception listed as a covered Table injury. This proposal was based on data indicating a strong association between Rotashield and intussusception in the two weeks following vaccination.
        In a final rule published July 25, 2002 (67 FR 48558), the Secretary made final the changes proposed in the earlier notice. After these amendments, the Table included two categories of rotavirus vaccines. The first, the general category of rotavirus vaccines, did not include an associated injury. This category of vaccines was effective as of October 22, 1998, the effective date of the excise tax imposed for rotavirus vaccines. See 42 CFR 100.3(a), 100.3(c)(3). The second, more specific category of vaccines containing live, oral, rhesus-based rotavirus, contained an associated injury of intussusception with an onset interval of 0-30 days. The live, oral, rhesus-based rotavirus vaccine was covered in the VICP effective October 22, 1998, but the Table injury could only be claimed by those petitioners that had the vaccine administered on or before August 26, 2002 (the effective date of the final rule adding this category of vaccine), and beginning on August 26, 1994, the period of the eight-year “look back” prescribed in the statute. Because the manufacturer of the only U.S.-licensed rotavirus vaccine at the time voluntarily ceased distribution of the vaccine in July 1999, and because the CDC recommended that this vaccine no longer be routinely administered to children in the United States in October 1999, the Secretary concluded that it was unlikely that potential claims under this specific category would arise after the rule's publication. Because of this, the final rule limited the Table injury of intussusception to live, oral, rhesus-based rotavirus vaccines administered on or before the effective date of the final rule (August 26, 2002). Individuals who sought compensation for injuries related to such a vaccine administered after the effective date of the final rule were not entitled to the presumption of a Table injury for intussusception, but such individuals could still file claims under the Table's general category for rotavirus vaccines.
        Through an interim final rule published October 9, 2008 (73 FR 59528), the Secretary removed the specific category of vaccines containing live, oral, rhesus-based rotavirus from the Table. Given the applicable statute of limitations and the fact that this category limited its application to vaccines administered on or before August 26, 2002, the Secretary believed that any potential Table claim under this category would have been time-barred, so no persons could have had claims under that category.
        Subsequent Rotavirus Vaccines

        On February 3, 2006, the FDA licensed a pentavalent human-bovine reassortant rotavirus vaccine (trade name “RotaTeq”). Following a review by ACIP, the CDC published its recommendation for routine vaccination of U.S. infants with three doses of this rotavirus vaccine administered orally at ages 2, 4, and 6 months (MMWR 2006:55; RR12). On April 3, 2008, the FDA licensed a monovalent rotavirus vaccine derived from the human rotavirus strain (trade name “Rotarix”). In June 2008, the CDC updated its recommendation to include use of the newly licensed Rotarix (MMWR 2009:58; RR02). The prelicensure clinical trials for RotaTeq examined 70,000 infants, and did not identify an increased risk of intussusception in the 1-42 days post immunization. In addition, the prelicensure clinical trials for Rotarix examined over 60,000 infants, and found no increased risk in the 1-31 days after vaccination with either dose. Because of the prior association of intussusception with Rotashield, multiple post-marketing studies regarding RotaTeq, Rotarix, and intussusception were conducted to evaluate the possibility of a small risk of intussusception as utilization increased.
        RotaTeq Scientific History
        In February 2007, the FDA notified health care providers and consumers about 28 post-marketing reports of intussusception following administration of RotaTeq. The notification stated that of the reported 28 cases of intussusception, the number that may have been caused by the vaccine, or occurred by coincidence, was unknown. The FDA issued this notification both to encourage the reporting of any additional cases of intussusception that may have occurred in the past or will occur in the future after administration of RotaTeq, and to remind people that intussusception may be a potential complication of RotaTeq.
        In 2008, the Vaccine Safety Datalink (VSD) published their experience from the first 111,521 doses of RotaTeq given from 2006 to 2007, and in 2012, the VSD and the CDC published data in “The Journal of the American Medical Association” (JAMA), from 786,725 doses of RotaTeq given from 2006 to 2010. There was no identifiable risk in the 1-7 day or 1-30 day periods following administration of RotaTeq in either analysis. The final post-marketing study of RotaTeq in the U.S. was performed by Merck and found no association with intussusception and RotaTeq. Post-marketing clinical trials of RotaTeq performed after U.S. licensure included two smaller efficacy studies from Africa and Asia. The African study had no cases of intussusception in either vaccine or placebo groups, and the Asian study had one case 97 days following the third dose of the placebo, and no cases in the vaccine group.
        A 2011 post-marketing study of RotaTeq published in “Vaccine,” from the Australian National Immunization Program, suggests an association between RotaTeq and intussusception. Approximately 295,000 doses of RotaTeq were given in two states. In 1-3 month old infants, the expected number of intussusception cases was exceeded for the 1-7 and 1-21 day periods following the first dose of RotaTeq. In the 1-7 days following the first dose, three cases were found, compared to an expected 0.57 cases (relative risk of 5.26 [confidence interval (CI), 1.1-15.4]). (Relative risk is the ratio of the chance of a disease developing among members of a population exposed to a factor compared with a similar population not exposed to the factor.) [Confidence Intervals are a measure of estimation that represents the possible range of values in a population estimated from a given sample drawn from that population (in this case ranging from a relative risk value of 1.1 to 15.4)].
        When the 1-21 day interval following the first dose was examined, six cases of intussusception were found, compared to an expected 1.71 cases (relative risk 3.5 [CI, 1.3-7.6]). There was no increase from the expected cases after dose two of RotaTeq, and actually a decrease from expected cases after dose three. Also important to note is that there was no evidence of increased risk of intussusception when examining the entire period of 1-9 months of age.
        Rotarix Scientific History
        Rotarix was given in the other two states evaluated in the Australian post-marketing study, totaling approximately 302,000 doses. The study demonstrated an increased risk in both the 1-7 day and the 1-21 day windows following the first dose of Rotarix (relative risk of 3.45 [CI 0.7-10] and 1.53 [CI, 0.4-3.9], respectively). Neither of these risks showed statistical significance. There were no excess cases of intussusception associated with dose two of Rotarix. Similar to RotaTeq, the number of observed cases in the post-vaccine windows was small, with three cases observed in the 1-7 days after first dose vaccination versus 0.9 cases expected for the 1-3 month old infants. Since Rotarix constitutes a small percentage of total rotavirus vaccine given in the U.S. (3 million doses of Rotarix versus 35 million doses of RotaTeq as of 2010), comparable U.S. post-licensure studies of Rotarix are not currently available.
        Post-marketing studies (case series and case-control analysis) performed in Mexico and Brazil, and published in “The New England Journal of Medicine” in 2011, identified an association between Rotarix and intussusception. In Mexico, there was an increased rate of intussusception during the 1-7 day period after the first dose of Rotarix with an incidence rate ratio of 5.3 (CI, 3-9.3). (Incidence rate ratio compares two incidence rates. Incidence rate is the number of new cases per population in a given time period.) There was no increase in the rate 1-7 days after the second dose, but a small increase by a factor of two was identified in the second and third week following the second dose. This contrasts with the Brazil data where there was no increase in the rate of intussusception found after the first dose of Rotarix, but a small elevation of the rate was identified 1-7 days following the second dose (incidence ratio of 2.6 [CI, 1.3-5.2]). The reason behind the variation between the data from Mexico and Brazil is unclear, but one potential explanation could be a result of Brazil's administering Rotarix and the oral polio virus vaccine (OPV) together, which has been shown to decrease the immunogenicity of the first dose of Rotarix, perhaps making the second dose function more like the initial dose.
        The commentary in “The New England Journal of Medicine” in 2011 regarding the Rotarix data from Mexico and Brazil summarized the small attributable risk of intussusception as 1/51,000 vaccinated infants in Mexico and 1/68,000 vaccinated infants in Brazil. [Attributable risk is the difference in rate of a condition (intussusception in this case) between an exposed population (those who received rotavirus vaccine in this case) and an unexposed population.] The article raised the possibility that any live, oral, rotavirus vaccine, along with natural rotavirus infection, could carry a detectable risk of intussusception, although the risk is demonstrably quite low, based on the available studies. It is also biologically plausible that the different vaccines have differing intrinsic risks of intussusception based on the distinct strains in each vaccine, and that the same vaccine could manifest different risks in different populations. It is also possible that with small risks overall (resulting in a small number of excess intussusception cases in the specific narrow age groups receiving vaccine) and variability in background numbers of cases of intussusception year to year, an increase in overall burden of intussusception in infants aged < 1 year may not be detectable. The article raised the point that the small increase of intussusception after vaccination does not seem to increase the overall burden of intussusception, and that perhaps the rotavirus vaccination has a preventive role in long-term intussusception risk.

        Because of these findings, the prescribing information in the U.S. for Rotarix was amended in September 2010 to reflect the above increased risk and the potential implications for U.S. infants. (GlaxosmithKline Biologicals Package Insert (PI) and Patient Package Information (PPI)). The PI and PPI were further amended in February 2011 to include “history of intussusception” as a contraindication to vaccination. (Statement available for viewing at
          http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm245491.htm). A “history of intussusception” was also made a contraindication for Rotateq in July 2011.

        In addition, a large post-marketing surveillance study of intussusception in Mexico published in “The Pediatric Infectious Disease Journal” in July 2012 reported an “attributable risk of 3 to 4 additional cases of intussusception per 100,000 vaccinated infants after receipt if Rotarix.
        CDC Response

        In November 2010, the CDC issued a statement noting that some, but not all, studies suggest RotaTeq and Rotarix may possibly cause a small increase in the risk of intussusception; however, the CDC concluded that the benefits of these vaccines far outweigh this possible risk. The CDC continues to recommend routine rotavirus vaccination of U.S. infants to prevent severe rotavirus disease in U.S. infants and children. (Statement available for viewing at http://www.cdc.gov/vaccines/vpd-vac/rotavirus/intussusception-studies-acip.htm).
        The FDA's mini-sentinel “Post-Licensure Rapid Immunizations Safety Monitoring Program” (PRISM) is currently performing a study to assess the risk of intussusception from both Rotarix and RotaTeq vaccines in the United States. This self-controlled and case-centered study targets approximately 1 million infants. Results are expected late in 2012.
        Proposed Rule
        The Secretary has reviewed all the currently available data regarding the Rotarix and RotaTeq vaccines and the risk of intussusception. The background of the Rotashield experience in the U.S. and the recently published literature from Mexico, Brazil, and Australia supports a small attributable risk of intussusception after the first and second doses of Rotarix and RotaTeq (with a greater amount of data supporting an association with the first dose of both vaccines). Therefore, the Secretary proposes that the injury of intussusception be added to the general Table category of “rotavirus vaccines” to allow a presumption of causation for claims that meet the requirements set forth in the Table for that injury. Current U.S. studies of RotaTeq do not show a statistically identifiable risk of intussusception, but the number of study patients exposed to the vaccine in the U.S. may not be large enough (even with the results expected from the ongoing PRISM study) to rule out a very small attributable risk to the vaccine. Platforms like VSD in the U.S. have not been able to evaluate the possible small risk associated with Rotarix to date because of the low numbers of doses of Rotarix administered in settings captured by the surveillance program. To allow for a generous timeframe, the Secretary proposes that the Table injury for intussusception have an onset interval of 1-21 days under sections 2114(c) and (e) of the PHS Act, since evidence shows the increased risk within the 1-7 days following immunization with peaks in the fourth and fifth days.
        The Qualifications and Aids to Interpretation section of the table will define the injury of “intussusception” as the invagination of a segment of intestine into the next segment of intestine, resulting in bowel obstruction, diminished arterial blood supply, and blockage of the venous blood flow. This is characterized by a sudden onset of abdominal pain that may be manifested by anguished crying, irritability, vomiting, abdominal swelling, and/or passing of stools mixed with blood and mucus. The definition for presumption of vaccine causation only applies to the first and second dose of vaccine, and excludes intussusception occurring with or after the third dose. The third dose of rotavirus vaccines lacks sufficient evidence showing risk.
        The definition also delineates the alternative causes of intussusception which, if present in a case, would prevent it from qualifying as a Table injury. The alternative causes were classified into four categories: infectious diseases; anatomic lead points; anatomic bowel abnormalities; and underlying gastrointestinal or systemic diseases. Cases of intussusception where the onset was within 14 days after an infectious disease secondary to non-enteric or enteric adenovirus, other enteric viruses (such as Enterovirus), enteric bacteria (such as Campylobacter jejuni), or enteric parasites (such as Ascaris lumbricoides) would not qualify as a Table injury. Proof of these alternate causes may be demonstrated by clinical signs and symptoms and need not be confirmed by culture or serologic testing.
        Cases of intussusception in a person with a pre-existing condition identified as the lead point for intussusception, such as intestinal masses and cystic structures (e.g., polyps; tumors; Meckel's diverticulum; lymphoma; or duplication cysts), would not qualify as a Table injury. Additionally, cases of intussusception in a person with abnormalities of the bowel, including congenital anatomic abnormalities, anatomic changes after abdominal surgery, and other anatomic bowel abnormalities caused by mucosal hemorrhage, trauma, or abnormal intestinal blood vessels (such as Henoch Scholein purpura, hematoma, or hemangioma); or in a person with underlying conditions or systemic diseases associated with intussusception (such as cystic fibrosis, celiac disease, or Kawasaki disease) would not qualify as a Table injury.
        Petitioners may be eligible for compensation for vaccine-related cases of intussusception in which the onset is before 1 day or beyond 21 days, or where the condition does not satisfy the criteria under the Qualifications and Aids to Interpretation for intussusception (an “off-Table” claim), however the petitioners will be required to prove causation-in-fact. Regardless of whether the claim satisfies the criteria in the Table, all petitioners must demonstrate sufficient severity of the injury by proving that the injured person: 1) suffered the residual effects or complications of the alleged vaccine-related injury for more than 6 months after vaccine's administration; 2) died from administration of the vaccine; or 3) sustained inpatient hospitalization and surgery as a result of the alleged vaccine-related injury. Section 2111(c)(1)(D), PHS Act (42 U.S.C. 300aa-11(c)(1)(D)). In the case of rotavirus vaccine administration and subsequent intussusception, the Secretary does not consider a reduction of intussusception with an enema to be “surgical intervention.”
        Petitions must also be filed within the applicable statute of limitations. The general statute of limitations applicable to petitions filed with the VICP, set forth in section 2116(a) of the PHS Act (42 U.S.C. 300aa-16(a)), continues to apply. In addition, section 2116(b) of the PHS Act identifies a specific exception to this statute of limitations that applies when the effect of a revision to the Table makes a previously ineligible person eligible to receive compensation or when an eligible person's likelihood of obtaining compensation significantly increases. Under this section, individuals who may be eligible to file petitions based on the revised Table may file a petition for compensation not later than 2 years after the effective date of the revision if the injury or death occurred not more than 8 years before the effective date of the revision of the Table (42 U.S.C. 300aa-16(b)).

        The Advisory Commission on Childhood Vaccines (ACCV) voted unanimously to approve this proposal at its December 9, 2011, meeting. The Secretary, while moving forward with this proposal, understands that additional science is still forthcoming and recognizes the importance of keeping the Vaccine Injury Table in conformance with science. In addition, the Secretary recognizes that one goal of the VICP is to provide generous compensation to petitioners harmed by vaccines through a less adversarial system. Although post-marketing studies in the U.S. have not identified an increased risk of intussusception associated with rotavirus vaccine, a small risk cannot be ruled out. Therefore, the Secretary feels that the balance between science and policy is best met by acting now, on the basis of the studies outside the U.S. that have detected an increased risk of intussusception following Rotarix and RotaTeq vaccines, rather than waiting to see if the PRISM, VSD, and other studies further bolsters the already published findings.
        Economic and Regulatory Impact
        Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits (including potential economic, environmental, public health, safety, distributive, and equity effects). In addition, under the Regulatory Flexibility Act, if a rule has a significant economic effect on a substantial number of small entities, the Secretary must specifically consider the economic effect of a rule on small entities and analyze regulatory options that could lessen the impact of the rule.
        Executive Order 12866 requires that all regulations reflect consideration of alternatives, costs, benefits, incentives, equity, and available information. Regulations must meet certain standards, such as avoiding an unnecessary burden. Regulations that are “significant” because of cost, adverse effects on the economy, inconsistency with other agency actions, effects on the budget, or novel legal or policy issues, require special analysis.
        The Secretary has determined that no resources are required to implement the requirements in this rule. Compensation will be made in the same manner. This proposed rule only lessens the burden of proof for potential petitioners. Therefore, in accordance with the Regulatory Flexibility Act of 1980 (RFA) and the Small Business Regulatory Enforcement Act of 1996, which amended the RFA, the Secretary certifies that this rule will not have a significant impact on a substantial number of small entities.
        The Secretary has also determined that this proposed rule does not meet the criteria for a major rule as defined by Executive Order 12866, and it would not have a major effect on the economy or federal expenditures. The Department has determined that the proposed rule is not a “major rule” within the meaning of the statute providing for Congressional Review of Agency Rulemaking, 5 U.S.C. § 801. Similarly, it will not have effects on state, local, and tribal governments, or on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995.
        The Secretary finds that the provisions of this rule will not have an adverse affect on family well-being, because this rule does not affect the following family elements: family safety; family stability; marital commitment; parental rights in the education, nurture, and supervision of their children; family functioning; disposable income or poverty; or the behavior and personal responsibility of youth, as determined under section 654(c) of the Treasury and General Government Appropriations Act of 1999.
        This rule is not being treated as a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget.
        As stated above, this proposed rule would modify the Vaccine Injury Table based on legal authority.
        Impact of the New Rule
        To date, 17 petitions have been filed alleging a vaccine-related injury of intussusception caused or aggravated by a rotavirus vaccine, not including the currently unavailable Rotashield vaccine. This proposed rule will have the effect of decreasing the burden of proof for future petitioners. Under this proposed rule, future petitioners alleging the injury of intussusception as the result of a rotavirus vaccine that meets the criteria in the Vaccine Injury Table will be afforded a presumption of causation. This proposed rule will not change the burden of proof applicable to petitioners alleging other injuries related to a rotavirus vaccine who must rely on a causation-in-fact analysis.
        Paperwork Reduction Act of 1980
        This proposed rule has no information collection requirements.

          List of Subjects in 42 CFR Part 100
          Biologics, Health Insurance, and Immunization.

          Dated: June 26, 2013.
          Mary Wakefield,
          Administrator, Health Resources and Services Administration.
          Approved: July 17, 2013.
          Kathleen Sebelius,
          Secretary.

        Accordingly, 42 CFR part 100 is proposed to be amended as set forth below:

          PART 100—VACCINE INJURY COMPENSATION.

        1. The authority citation for 42 CFR part 100 continues to read as follows:

          Authority:
           Sec. 215 of the Public Health Service Act (42 U.S.C. 216); sec. 2115 of the PHS Act; 100 Stat. 3767, as revised (42 U.S.C. 300aa-15); § 100.3 Vaccine Injury Table, issued under secs. 312 and 313 of Pub. L. 99-660, 100 Stat. 3779-3782 (42 U.S.C. 300aa-1 note); and sec. 2114(c) and (3) of the PHS Act, 100 Stat. 3766 and 107 Stat. 645 (42 U.S.C. 300aa-14(c) and (e)); sec. 904(b) of Pub. L. 105-34, 111 Stat. 873; and sec. 523(a) of Pub. L. 106-170, 113 Stat. 1860.

        2. Amend § 100.3 in the paragraph (a) table by revising Item XI and by adding paragraph (b)(3) to read as follows:

          § 100.3
          Vaccine injury table.
          (a) * * *

            Vaccine Injury Table

              Vaccine
              Illness, disability, injury, or condition covered
              Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration

              *         *         *         *         *         *         *

              XI. Rotavirus vaccines
              A. IntussusceptionB. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed

              1-21 days.Not applicable.

              *         *         *         *         *         *         *

          (b) * * *
          (3) Intussusception. (i) For purposes of paragraph (a) of this section, intussusception means the invagination of a segment of intestine into the next segment of intestine, resulting in bowel obstruction, diminished arterial blood supply, and blockage of the venous blood flow. This is characterized by a sudden onset of abdominal pain that may be manifested by anguished crying, irritability, vomiting, abdominal swelling, and/or passing of stools mixed with blood and mucus.
          (ii) For purposes of paragraph (a) of this section, the following shall not be considered to be a Table intussusception:
          (A) Onset that occurs with or after the third dose of a vaccine containing rotavirus;

          (B) Onset within 14 days after an infectious disease associated with intussusception, including viral disease (such as those secondary to non-enteric or enteric adenovirus, or other enteric viruses such as Enterovirus), enteric bacteria (such as Campylobacter jejuni), or enteric parasites (such as Ascaris lumbricoides), which may be demonstrated by clinical signs and symptoms and need not be confirmed by culture or serologic testing;
          (C) Onset in a person with a pre-existing condition identified as the lead point for intussusception such as intestinal masses and cystic structures (such as polyps, tumors, Meckel's diverticulum, lymphoma, or duplication cysts);
          (D) Onset in a person with abnormalities of the bowel, including congenital anatomic abnormalities, anatomic changes after abdominal surgery, and other anatomic bowel abnormalities caused by mucosal hemorrhage, trauma, or abnormal intestinal blood vessels (such as Henoch Scholein purpura, hematoma, or hemangioma); or
          (E) Onset in a person with underlying conditions or systemic diseases associated with intussusception (such as cystic fibrosis, celiac disease, or Kawasaki disease).

      [FR Doc. 2013-17786 Filed 7-23-13; 8:45 am]
      BILLING CODE 4165-15-P


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 648
        [I.D. 090500A]
        New England Fishery Management Council; Public Meeting

          AGENCY:
          National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

          ACTION:
          Public meetings.

          SUMMARY:
          The New England Fishery Management Council (Council) will hold a 3-day public meeting on September 26, 27, and 28, 2000, to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). During this timeframe, the Council's Herring Oversight Committee also will meet.

          DATES:
          The Herring Oversight Committee will meet on Tuesday, September 26 at 8:30 a.m. Following the committee meeting, the full Council will meet on Tuesday, September 26 at 10:30 a.m., and on Wednesday, September 27, and Thursday, September 28, 2000, beginning at 8:30 a.m.

          ADDRESSES:
          The meetings will be held at the Holiday Inn Express (formerly Seaport Inn Conference Center), 110 Middle Street, Fairhaven, MA 02719; telephone (508) 997-1281. Requests for special accommodations should be addressed to the New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950; telephone (978) 465-0492.

          FOR FURTHER INFORMATION CONTACT:
          Paul J. Howard, Executive Director, New England Fishery Management Council, (978) 465-0492.

        SUPPLEMENTARY INFORMATION:
        Tuesday, September 26, 2000
        The Herring Oversight Committee will meet to develop recommendations for consideration by the full Council on herring foreign fishing permit conditions and restrictions. Recommendations may be specific to a permit application already submitted by Lithuania, or may be applicable to any subsequent permit applications received for the 2001 fishing year (January 1, 2001-December 31, 2001). Following the Herring Committee meeting, the Council will swear in new and re-appointed members, and elect 2000-2001 officers. The Herring Committee will then provide its recommendations on herring foreign fishing permit conditions and restrictions. The Capacity Committee will recommend for consideration by the Groundfish Committee proposals that will allow the transfer of fishing permits, address latent (unused) days-at-sea (DAS), and allow the transfer of groundfish DAS.
        Wednesday, September 27, 2000
        The Scallop Committee's report will be presented on the second day of the Council meeting and will include a presentation of the 2000 Stock Assessment and Fishery Evaluation (SAFE) Report on the sea scallop resource. The Council will also consider approval of initial action on the annual adjustment to the Atlantic Sea Scallop Fishery Management Plan (FMP). Discussion will focus on selection of management alternatives. Issues may include, but are not limited to, DAS allocations, access to the Hudson Canyon and Virginia/North Carolina closed areas, new area closures, and a prohibition on shell stocking.
        Thursday, September 28, 2000

        The third day of the meeting will begin with reports on recent activities from the Council Chairman, Executive Director, the NMFS Regional Administrator, Northeast Fisheries Science Center and Mid-Atlantic Fishery Management Council liaisons, and representatives of the Coast Guard, NMFS Enforcement and the Atlantic States Marine Fisheries Commission. There will also be a report on the Northwest Atlantic Fisheries Organization's most recent meeting. The Groundfish Overfishing Definition Committee will report on its review of the Council's overfishing definitions. The Groundfish Committee will then provide an update on development of management options for Amendment 13 to the Northeast Multispecies FMP, including a discussion of alternatives within the status quo management option, area management option(s), and a sector allocation option. The chairman also will report on committee discussions concerning rebuilding schedules of overfished groundfish stocks. Following the Groundfish Committee discussions, there will be a presentation of the available skate stock assessment and fishery information to be included in the Skate SAFE Report. The Skate Committee will provide its recommendation on issues to be included in a scoping document for a Skate FMP. The Enforcement Committee will provide the Council with its recommendations concerning a safe harbor experimental fishery that would allow vessels to enter Gloucester Harbor without unloading haddock trip limit overages. The Habitat Committee will ask the Council to approve a response to the Atlantic States Marine Fisheries Commission’s request for comments on a report about gear impacts on submerged aquatic vegetation. There will be updates on the activities of the Mid-Atlantic Council’s FMPs’ Research Steering and Monkfish Committees. After addressing any other outstanding business, the Council will adjourn.
        Although other non-emergency issues not contained in this agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
        The Council will consider public comments at a minimum of two Council meetings before making recommendations to the NMFS Regional Administrator on any framework adjustment to a fishery management plan. If she concurs with the adjustment proposed by the Council, the Regional Administrator has the discretion to publish the action either as proposed or final regulations in the Federal Register. Documents pertaining to framework adjustments are available for public review 7 days prior to a final vote by the Council.
        Special Accommodations

        This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Paul J. Howard (see ADDRESSES) at least 5 days prior to the meeting date.

          Dated: September 7, 2000.
          Bruce C. Morehead,
          Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.

      [FR Doc. 00-23399 Filed 9-11-00; 8:45 am]
      BILLING CODE 3510-22-S


        NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
        48 CFR Parts 1827, 1835, and 1852
        RIN 2700-AC33
        Scientific and Technical Reports

          AGENCY:
          National Aeronautics and Space Administration (NASA)

          ACTION:
          Proposed rule.

          SUMMARY:
          This proposed rule would amend the NFS to clarify the review requirements for data produced under Research and Development (R&D) contracts including data contained in final reports and the review requirements for final reports prior to inclusion in NASA's Center for AeroSpace Information (CASI).

          DATES:
          Comments should be submitted on or before January 14, 2002.

          ADDRESSES:

          Interested parties should submit written comments to Celeste Dalton, NASA Headquarters, Office of Procurement, Contract Management Division (Code HK), Washington, DC 20546. Comments may also be submitted by e-mail to: cdalton@hq.nasa.gov.

          FOR FURTHER INFORMATION CONTACT:
          Celeste Dalton, (202) 358-1645, e-mail: cdalton@hq.nasa.gov.

        SUPPLEMENTARY INFORMATION:
        A. Background

        NFS clause 1852.235-70, Center for Aerospace Information—Final Scientific and Technical Reports, is required in all R&D contracts. Paragraph (e) of the current NFS clause 1852.235-70 requires that contractors not release the final report required under the contract, outside of NASA, until a document availability authorization (DAA) review has been completed by NASA and availability of the report has been determined. The DAA review completed by NASA is intended to insure that NASA disseminates NASA scientific and technical information (STI) in a manner consistent with U.S. laws and regulations, Federal information policy, intellectual property rights, technology transfer protection requirements, and budgetary and technological limitations. The DAA review process applies only to the publication and dissemination of NASA STI by NASA or under the direction of NASA.
        This final report review requirement has been incorrectly interpreted by some university contractors as restricting their right to publish any of the data produced under the contract which may be included in the Final Report until NASA has completed its DAA review. The intent of paragraph (e) is to restrict only the release of the “The Final Report” as delivered under the contract until NASA completes its DAA review and availability of the report has been determined. This clause does not restrict the contractor's ability to publish, or otherwise disseminate, data produced during the performance of the contract, including data contained in the Final Report, as provided under FAR clause 52.227-14, Rights in Data—General. However, in certain limited situations, contract requirements may include research activity that will result in data subject to export control, national security restrictions, or other restrictions designated by NASA, or may require that the contractor receives or is given access to data that includes restrictive markings, e.g., proprietary information of others. In these circumstances, NASA requires a review of data produced under the contract, before the contractor may publish, release, or otherwise disseminate the data.
        This proposed rule clarifies the above by—
        (a) Revising the existing clause, 1852.235-70, to delete reference to the submission of the final report. This revised clause is titled “Center for Aerospace Information,” and will advise contractors of the services provided by CASI;
        (b) Establishing a new clause 1852.235-73, Final Scientific and Technical Reports, that requires submission of a final report; states that the contractor may publish, or otherwise disseminate, data produced during the performance of the contract, including data contained in the final report, without prior review by NASA; and retains restriction on release of the final report as delivered under the contract until NASA has completed its DAA review;
        (c) Establishing an Alternate I to the new 1852.235-73 clause, that may be used in contracts for fundamental research in which the contractor may publish, or otherwise disseminate, data produced during performance of the contract, including the final report, without prior review by NASA;
        (d) Establishing an Alternate II to the new 1852.235-73 clause, for use in contracts in which data resulting from the research activity may be subject to export control, national security restrictions or other restrictions designated by NASA, may include information disclosing an invention in which the government may have rights, or, to the extent the contractor receives or is given access to data that includes restrictive markings, may include proprietary information of others, and will require the contractor to comply with NASA review requirements contained in the new clause, 1852.235-75, Review of Final Scientific and Technical Reports and Other Data;
        (e) Establishing a new clause 1852.235-74, Additional Reports of Work—Research and Development, for use in contracts in which monthly, quarterly and other reports in addition to the Final Report may be considered necessary for monitoring contract performance;
        (f) Establishing a new clause 1852.235-75, Review of Final Scientific and Technical Reports and Other Data, for use in contracts in which data resulting from the research activity may be subject to export control, national security restrictions or other restrictions designated by NASA, may include information disclosing an invention in which the government may have rights, or, to the extent the contractor receives or is given access to data that includes restrictive markings, may include proprietary information of others, and thus will require NASA review of data produced under the contract before the contractor may publish, release, or otherwise disseminate data produced during the performance of the contract; and
        (g) Moving the coverage for Reports of Work from Part 1827, Patents, Data, and Copyrights, to 1835, Research and Development Contracting, by deleting section 1827.406-70, Reports of Work, and adding sections 1835.010, Scientific and technical reports, and 1835.011, Data.
        B. Regulatory Flexibility Act

        NASA certifies that this proposed rule will not have a significant economic impact on a substantial number of small business entities within the meaning of the Regulatory Flexibility Act (5 U.S.C. 601, et. seq.), because these changes only clarify existing rights and responsibilities relating to release of data produced in performance of a contract.
        C. Paperwork Reduction Act

        The Paperwork Reduction Act does not apply because the proposed changes to the NFS do not impose any recordkeeping or information collection requirements, or collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

          List of Subjects in 48 CFR Parts 1827, 1835, and 1852
          Government procurement.

          Tom Luedtke,
          Associate Administrator for Procurement.

        Accordingly, 48 CFR Parts 1827, 1835, and 1852 are proposed to be amended as follows:
        1. The authority citation for 48 CFR Parts 1827, 1835, and 1852 continues to read as follows:

          Authority:
          42 U.S.C. 2473(c)(1).

          PART 1827—PATENTS, DATA, AND COPYRIGHTS
          2. Delete section 1827.406-70.

          PART 1835—RESEARCH AND DEVELOPMENT CONTRACTING
          3. Add sections 1835.010 and 1835.011 to read as follows:

            1835.010
            Scientific and technical reports.
            (a)(i) Final reports. Final reports must be furnished by contractors for all R&D contracts. The final report should summarize the results of the entire contract, including recommendations and conclusions based on the experience and results obtained. The final report should include tables, graphs, diagrams, curves, sketches, photographs, and drawings in sufficient detail to explain comprehensively the results achieved under the contract. The final report should comply with formatting and stylistic guidelines contained in NPG 2200.2A, Guidelines for Documentation, Approval, and Dissemination of NASA Scientific and Technical Information. The contracting officer must specify in the contract whether the use of electronic formats for submission of reports is acceptable. Information regarding appropriate electronic formats is available from Center STI Managers or the NASA Center for AeroSpace Information (CASI).

            (ii) In addition to the final report submitted to the contracting officer, the contractor must concurrently provide the NASA Center for AeroSpace Information (CASI) with a copy of the letter transmitting the final report to the contracting officer.

            (iii) It is NASA policy to provide the widest practicable and appropriate dissemination of scientific and technical information (STI) derived from NASA activities, including that generated under NASA research and development contracts. One mechanism for disseminating NASA STI is through CASI. Before approving a final report delivered under a contract for inclusion in the CASI repository, NASA must complete a Document Availability Authorization (DAA) review. The DAA review is intended to insure that NASA disseminates NASA scientific and technical information (STI) in a manner consistent with U.S. laws and regulations, federal information policy and publication standards, intellectual property rights, technology transfer protection requirements, and budgetary and technological limitations. NASA Form 1676, NASA Scientific and Technical Document Availability Authorization (DAA), or a Center-specific version of this form, is used to complete this review. The DAA review process applies to the publication and dissemination of NASA STI by NASA or under the direction of NASA. The final report, as delivered under the contract, must not be released outside of NASA until NASA's DAA review has been completed and the availability of the document has been determined.
            (iv) Additional reports of work. In addition to the final report required by paragraph (a)(i) of this section, the contracting officer, in consultation with the program or project manager, should consider the desirability of requiring periodic reports and reports on the completion of significant units or phases of work for monitoring contract performance. Any additional reports must be included in the clause at 1852.235-74 as a contract deliverable. (See FAR 27.403.)
            (v) Upon receipt of the Final Report, or any additional reports required by 1852.235-74 if included in the contract, the contracting officer must forward the reports to the contracting officer's technical representative (COTR) for review and acceptance. The COTR must ensure that the DAA review is initiated upon receipt of the final report. With respect to any additional reports required by 1852.235-74, if NASA wishes to disseminate such additional reports outside of NASA, the COTR must ensure that the DAA review is initiated upon receipt of such additional reports. Upon completion of the DAA review, the COTR must advise the contracting officer and contractor of the final availability determination and submit the final report along with the final availability determination to CASI. A copy of the letter transmitting the final report to CASI must be submitted to the contracting officer. These responsibilities should be included in the COTR Delegation, NASA Form 1634.
            (b) The final report must include a completed Report Documentation Page, Standard Form (SF) 298, as the final page of the report.

            1835.011
            Data.
            (a) In addition to any reports required by 1835.010, the contracting officer must specify what additional data, (type, quantity, and quality) is required under the contract, for example, presentations, journal articles, and seminar notes. (See FAR 27.403.)
            4. Revise section 1835.070 to read as follows:

            1835.070
            NASA contract clauses and solicitation provision.
            (a) The contracting officer must insert the clause at 1852.235-70, Center for AeroSpace Information, in all research and development contracts, and interagency agreements and cost-reimbursement supply contracts involving research and development work.
            (b) The contracting officer must insert the clause at 1852.235-71, Key Personnel and Facilities, in contracts when source selection has been substantially predicated upon the possession by a given offeror of special capabilities, as represented by key personnel or facilities.
            (c) The contracting officer must ensure that the provision at 1852.235-72, Instructions for Responding to NASA Research Announcements, is inserted in all NRAs. The instructions may be supplemented, but only to the minimum extent necessary.
            (d)(1) The contracting officer must insert the clause at 1852.235-73, Final Scientific and Technical Reports, in all research and development contracts, and in interagency agreements and cost-reimbursement supply contracts involving research and development work.
            (2) The contracting officer, after consultation with and concurrence of the program or project manager and the Center Export Control Administrator, may insert the clause with its Alternate I when the contract includes “fundamental research” as defined at 22 CFR 120.11(8) and no prior review of data, including the final report, produced during the performance of the contract is required for export control or national security purposes before the contractor may publish, release, or otherwise disseminate the data.
            (3) The contracting officer must insert the clause with its Alternate II when the clause at 1852.235-75, Review of Final Scientific and Technical Reports and Other Data, as prescribed by paragraph (f) of this section, is included in the contract.
            (e) The contracting officer must insert a clause substantially the same as the clause at 1852.235-74, Additional Reports of Work—Research and Development, in all research and development contracts, and in interagency agreements and cost-reimbursement supply contracts involving research and development work, when periodic reports, such as monthly or quarterly reports, or reports on the completion of significant units or phases of work are required for monitoring contract performance. The clause should be modified to reflect the reporting requirements of the contract and to indicate the timeframe for submission of the final report.
            (f) The contracting officer, after consultation with and concurrence by the program or project manager and where necessary the Center Export Control Administrator, must insert a clause substantially the same as the clause at 1852.235-75, Review of Final Scientific and Technical Reports and Other Data, when prior review of all data produced during the performance of the contract is required before the contractor may publish, release, or otherwise disseminate the data. For example, when data produced during performance of the contract may be subject to export control, national security restrictions, or other restrictions designated by NASA; may include information disclosing an invention in which the government may have rights; or, to the extent the contractor receives or is given access to data that includes restrictive markings, may include proprietary information of others.

          PART 1852—SOLICITATION PROVISIONS AND CONTRACT CLAUSES
          5. Revise section 1852.235-70 to read as follows:

            1852.235-70
            Center for AeroSpace Information.
            As prescribed in 1835.070(a), insert the following clause:

              CENTER FOR AEROSPACE INFORMATION
              (XXX/XXX)

              (a) The Contractor should register with and avail itself of the services provided by the NASA Center for AeroSpace Information (CASI) (http://www.sti.nasa.gov) for the conduct of research or research and development required under this contract. CASI provides a variety of services and products as a NASA repository of research information, which may enhance contract performance.
              (b) Should the CASI information or service requested by the Contractor be unavailable or not in the exact form necessary by the Contractor, neither CASI nor NASA is obligated to search for or change the format of the information. A failure to furnish information shall not entitle the Contractor to an equitable adjustment under the terms and conditions of this contract.

              (c) Information regarding CASI and the services available can be obtained at the Internet address contained in paragraph (a) of this clause or at the following address. Center for AeroSpace Information (CASI), 7121 Standard Drive, Hanover, Maryland 21076-1320, Email: help@sti.nasa.gov, Phone: 301-621-0390, FAX: 301-621-0134.

              (End of clause)

            6. Add sections 1852.235-73, 1852.235-74 and 1852.235-75 to read as follows:

            1852.235-73
            Final Scientific and Technical Reports.
            As prescribed in 1835.070(d)(1) insert the following clause:

              FINAL SCIENTIFIC AND TECHNICAL REPORTS
              (XXX/XXX)
              (A) The Contractor shall submit to the Contracting Officer a final report which summarizes the results of the entire contract, including recommendations and conclusions based on the experience and results obtained. The final report should include tables, graphs, diagrams, curves, sketches, photographs, and drawings in sufficient detail to explain comprehensively the results achieved under the contract.
              (b) The final report shall be of a quality suitable for publication and shall follow the formatting and stylistic guidelines contained in NPG 2200.2A, Guidelines for Documentation, Approval, and Dissemination of NASA Scientific and Technical Information.
              (c) The last page of the final report shall be a completed Standard Form (SF) 298, Report Documentation Page.
              (d) In addition to the final report submitted to the Contracting Officer, the Contractor shall concurrently provide to CASI a copy of the letter transmitting the final report to the Contracting Officer. The copy of the letter shall be submitted to CASI at the following address: Center for AeroSpace Information (CASI), Attn: Document Processing Section, 7121 Standard Drive, Hanover, Maryland 21076-1320.
              (e) In accordance with paragraph (d) of the Rights in Data — General clause (52.227-14) of this contract, the Contractor may publish, or otherwise disseminate, data produced during the performance of this contract, including data contained in the final report, and any additional reports required by 1852.235-74 when included in the contract, without prior review by NASA. The Contractor is responsible for reviewing publication or dissemination of the data for conformance with laws and regulations governing its distribution, including intellectual property rights, export control, national security and other requirements, and to the extent the contractor receives or is given access to data necessary for the performance of the contract which contain restrictive markings, for complying with such restrictive markings. Should the Contractor seek to publish or otherwise disseminate the final report, or any additional reports required by 1852.235-74 if applicable, as delivered to NASA under this contract, the Contractor may do so once NASA has completed its document availability authorization review, and availability of the report has been determined.
              ALTERNATE I
              (XXX/XXX)
              As prescribed by 1835.070(d)(2), insert the following as paragraph (e) of the basic clause:
              (e) The data resulting from this research activity is “fundamental research” which will be broadly shared within the scientific community. No foreign national access or dissemination restrictions apply to this research activity. The Contractor may publish, release, or otherwise disseminate data produced during the performance of this contract, including the final report, without prior review by NASA for export control or national security purposes. However, NASA retains the right to review the final report to ensure that proprietary information, which may have been provided to the Contractor, is not released without authorization and for consistency with NASA publication standards. Additionally, the Contractor is responsible for reviewing any publication, release, or dissemination of the data for conformance with other restrictions expressly set forth in this contract, and to the extent it receives or is given access to data necessary for the performance of the contract which contain restrictive markings, for compliance with such restrictive markings.
              ALTERNATE II
              (XXX/XXX)
              As prescribed by 1835.070(d)(3), when the clause at 1852.235-75 is included in the contract, insert the following as paragraph (e) of the basic clause:
              (e) The Contractor shall comply with the requirements of 1852.235-75, Review of Final Scientific and Technical Reports and Other Data, before it publishes, releases, or otherwise disseminates any data or reports produced under this contract.

              (End of clause)

            1852.235-74
            Additional Reports of Work—Research and Development.
            As prescribed in 1835.070(e), insert a clause substantially the same as the following:

              ADDITIONAL REPORTS OF WORK—RESEARCH AND DEVELOPMENT
              (XXX/XXX)
              In addition to the final report required under this contract, the Contractor must submit the following report(s) to the Contracting Officer:
              (a) Monthly progress reports. The Contractor shall submit separate monthly reports of all work accomplished during each month of contract performance. Reports shall be in narrative form, brief, and informal. They shall include a quantitative description of progress, an indication of any current problems that may impede performance, proposed corrective action, and a discussion of the work to be performed during the next monthly reporting period.
              (b) Quarterly progress reports. The Contractor shall submit separate quarterly reports of all work accomplished during each three-month period of contract performance. In addition to factual data, these reports should include a separate analysis section interpreting the results obtained, recommending further action, and relating occurrences to the ultimate objectives of the contract. Sufficient diagrams, sketches, curves, photographs, and drawings should be included to convey the intended meaning.
              (c) Submission dates. Monthly and quarterly reports shall be submitted by the 15th day of the month following the month or quarter being reported. If the contract is awarded beyond the middle of a month, the first monthly report shall cover the period from award until the end of the following month. No monthly report need be submitted for the third month of contract effort for which a quarterly report is required. No quarterly report need be submitted for the final three months of contract effort since that period will be covered in the final report. The final report shall be submitted within ____days after the completion of the effort under the contract.

              (End of clause)

            1852.235-75
            Review of Final Scientific and Technical Reports and Other Data.
            As prescribed in 1835.070(f) insert the following clause:

              REVIEW OF FINAL SCIENTIFIC AND TECHNICAL REPORTS AND OTHER DATA
              (XXX/XXX)
              Data resulting from this research activity may be subject to export control, national security restrictions or other restrictions designated by NASA, may include information disclosing an invention in which the government may have rights, or, to the extent the Contractor receives or is given access to data necessary for the performance of the contract which contain restrictive markings, may include proprietary information of others. Therefore, the Contractor may not publish, release, or otherwise disseminate, except to NASA, data produced during the performance of this contract, including data contained in the final report required by 1852.235-73 and any additional reports required by 1852.235-74 when included in the contract, without prior review by NASA. Should the Contractor seek to publish, release, or otherwise disseminate data produced during the performance of this contract, the Contractor may do so once the review has been completed by NASA and the availability of the data has been determined.

      [FR Doc. 01-28242 Filed 11-13-01; 8:45 am]
      BILLING CODE 7510-01-P


        FEDERAL COMMUNICATIONS COMMISSION
        47 CFR Part 73
        [DA 08-2273; MB Docket No. 08-68; RM-11421]
        Radio Broadcasting Services; Beatty and Goldfield, NV

          AGENCY:
          Federal Communications Commission.

          ACTION:
          Proposed rule.

          SUMMARY:

          The Audio Division at the request of Keilly Miller proposes the allotment of Channel 259A at Beatty, Nevada and Channel 262C1 at Goldfield, Nevada to accommodate a hybrid FM change of community of license application that proposes the substitution of Channel 261C3 for Channel 261C at Beatty, Nevada, reallotment of Channel 261C3 from Beatty, Nevada to Crystal, Nevada, as its first local service. See File No. BMPH-20070727ABV. A staff engineering analysis indicates that Channel 259A can be allotted to Beatty consistent with the minimum distance separation requirements of the Rules with a site restriction 8.6 kilometers (5.3 miles) west located at reference coordinates 36-56-05 NL and 116-51-00 WL. Additionally, Channel 262C1 can be allotted to Goldfield consistent with the minimum distance separation requirements of the Commission's Rules (the “Rules”) with a site restriction 0.6 kilometers (0.4 miles) northeast of the community located at reference coordinates 37-42-41 NL and 117-13-56 WL.

          DATES:
          Comments must be filed on or before December 1, 2008, and reply comments on or before December 16, 2008.

          ADDRESSES:
          Secretary, Federal Communications Commission, 445 Twelfth Street, SW., Washington, DC 20554. In addition to filing comments with the FCC, interested parties should serve the petitioner, as follows: John S. Neely, Esq., Counsel to Keilly Miller, Miller and Neely, P.C., 6900 Wisconsin Avenue, Suite 704, Bethesda, MD 20815.

          FOR FURTHER INFORMATION CONTACT:
          Rolanda F. Smith, Media Bureau, (202) 418-2180.

        SUPPLEMENTARY INFORMATION:

        This is a synopsis of the Commission's Notice of Proposed Rule Making, MB Docket No. 08-68, adopted October 8, 2008, and released October 10, 2008. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 Twelfth Street, SW., Washington, DC 20554. This document may also be purchased from the Commission's duplicating contractors, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or via e-mail http://www.BCPIWEB.com. This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).
        Provisions of the Regulatory Flexibility Act of 1980 do not apply to this proceeding.

        Members of the public should note that from the time a Notice of Proposed Rule Making is issued until the matter is no longer subject to Commission consideration or court review, all ex parte contacts are prohibited in Commission proceedings, such as this one, which involve channel allotments. See 47 CFR 1.1204(b) for rules governing permissible ex parte contacts.
        For information regarding proper filing procedures for comments, see 47 CFR 1.415 and 1.420.

          List of Subjects in 47 CFR Part 73
          Radio, Radio broadcasting.

        For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR Part 73 as follows:

          PART 73—RADIO BROADCAST SERVICES
          1. The authority citation for part 73 continues to read as follows:

            Authority:
            47 U.S.C. 154, 303, 334, 336.

            § 73.202
            [Amended]
            2. Section 73.202(b), the Table of FM Allotments under Nevada, is amended by adding Beatty, Channel 259A and by adding Goldfield, Channel 262C1.

            Federal Communications Commission.
            John A. Karousos,
            Assistant Chief, Audio Division, Media Bureau.

      [FR Doc. E8-25347 Filed 10-22-08; 8:45 am]
      BILLING CODE 6712-01-P


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 697
        [Docket No. 070717357-7399-01]
        RIN 0648-AV77
        Atlantic Coastal Fisheries Cooperative Management Act Provisions; American Lobster Fishery

          AGENCY:
           National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce

          ACTION:
           Advance notice of proposed rulemaking (ANPR).

          SUMMARY:

           NMFS announces that it is considering and seeking public comment on the potential implementation of management measures in the Federal American lobster (Homarus americanus) fishery compatible with recommendations for Federal action as specified in the Atlantic States Marine Fisheries Commission's (Commission) Interstate Fishery Management Plan for American Lobster (ISFMP). These management measures may include: 100 percent mandatory dealer reporting requirements for Federal American lobster dealers; implementation of an American lobster maximum size limit (maximum carapace length restriction) in several Lobster Management Areas (LMA); and, revision to the definition of a V-notch for protection of egg-bearing female American lobsters in several LMAs in the Federal American lobster fishery. NMFS is considering implementation of these management measures based on ISFMP actions taken by the Commission in response to recommendations provided in the most recent peer-reviewed lobster stock assessment, completed by the Commission in December 2005.

          DATES:
           Comments must be received by October 22, 2007.

          ADDRESSES:

           Written comments should be sent to Harold Mears, State, Federal and Constituent Programs Office, Northeast Region, NMFS, One Blackburn Drive, Gloucester, MA 01930. Comments may also be sent via e-mail to LobsterJuly07@noaa.gov, via fax (978) 281-9117 or via the Federal e-Rulemaking portal at www.regulations.gov.

          FOR FURTHER INFORMATION CONTACT:

           Robert Ross, Fishery Management Specialist, (978) 281-9234, fax (978) 281-9117, e-mail bob.ross@noaa.gov.

        SUPPLEMENTARY INFORMATION:

        American lobsters are managed within the framework of the Commission. In 1999, NMFS transferred its Federal lobster fishery regulations from the New England Fishery Management Council (Council) to the Commission (64 FR 68228, dated December 6, 1999). The logic was straightforward, since 80 percent of the lobster fishery occurs in state waters, Federal action alone could no longer ensure that the Council process could prevent overfishing. The Commission is a deliberative body comprised of representatives both from the Atlantic coastal states and the Federal Government. The Commission serves to develop fishery conservation and management strategies for certain coastal species and coordinates the efforts of the states and Federal Government toward concerted sustainable ends. The Atlantic Coastal Fisheries Cooperative Management Act (Atlantic Coastal Act) 16 U.S.C. 5101 et seq., directs the Federal Government to support the management efforts of the Commission. Additionally, to the extent the Federal Government seeks to regulate a Commission species, the regulations must be (1) compatible with the effective implementation of an ISFMP developed by the Commission, and (2) consistent with the national standards set forth in section 301 of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq.). These Federal regulations are promulgated pursuant to the Atlantic Coastal Act and are codified at 50 CFR part 697.
        The Commission set forth the foundation of its American Lobster ISFMP in Amendment 3 to the ISFMP (Amendment 3), approved in December 1997. However, the Commission's American lobster management strategy is neither predicated upon a single measure nor is it contained within a single document. Rather, the structure is based on facilitating ongoing adaptive management with necessary elements implemented over time. The intent of Amendment 3 is to achieve a healthy American lobster resource and to develop a management regime that provides for sustained harvest, maintains opportunities for participation, and provides for the cooperative development of conservation measures by all stakeholders. In short, Amendment 3 was envisioned to provide much of the framework upon which future lobster management to be set forth in later addenda would be based. In particular, Amendment 3 employed a participatory management approach by creating the seven lobster management areas, each with its own lobster conservation management team (LCMT) comprised of industry members. Amendment 3 tasked the LCMTs with providing recommendations for area-specific management measures to the Board to meet the lobster egg production and effort reduction goals of the ISFMP. Eleven addenda to Amendment 3 have been approved since 1999, including Addendum X to Amendment 3 (Addendum X), approved in February 2007, and Addendum XI to Amendment 3 (Addendum XI), approved in May 2007. The measures proposed in this ANPR, and the recommendation by the Commission for the Federal Government to implement complementary regulations to those measures, are contained in Addenda X and XI.

        The purpose of Addenda I through IX to Amendment 3 was summarized in a previous ANPR published in the Federal Register on December 18, 2006 (71 FR75705). The actions specified in this document are based on actions taken by the Commission as a result of information contained in the most recent peer-reviewed lobster stock assessment completed by the Commission in December 2005. The 2005 lobster stock assessment reported that the American lobster resource presents a mixed picture for the three stocks of American lobster. The assessment indicated that there is stable abundance for the offshore Georges Bank (GBK) stock, and much of the Gulf of Maine (GOM) stock, and decreased abundance and recruitment, yet continued high fishing mortality rates, for the SNE stock and in Statistical Area 514 (Massachusetts Bay and Stellwagen Bank) in the GOM stock. In addition, echoing recommendations from the 2000 stock assessment, the 2005 assessment report stated that the scientific and statistical data available for lobster assessments are woefully inadequate for the management needs of the fishery, and that the primary limitation on the ability to manage lobster is limited data. One of the key recommendations of the 2005 assessment report was the need for implementation of a standardized mandatory reporting system for American lobster.

        Based on the 2005 stock assessment recommendations, a standardized mandatory reporting system for American lobster was incorporated in Addendum X. Addendum X establishes a coast-wide reporting and data collection program that includes both dealer and harvester reporting requirements. Specifically, the addendum requires states to implement, by January 1, 2008, 100 percent mandatory dealer reporting consistent with protocols under the Atlantic Coastal Cooperative Statistics Program (ACCSP) found at http://www.accsp.org/cfstandards.htm, and a reporting requirement for at least 10 percent of harvesters. Addendum X also includes recommendations for complementary Federal action. A review of 3,217 American lobster vessel permits indicates that an estimated 2,000 Federal lobster permit holders (62 percent of all Federal lobster fishing vessels) are subject to mandatory reporting requirements by virtue of regulations pertinent to other Federally managed fisheries. Thus, NMFS is already achieving the 10 percent target for the harvesting sector specified in Addendum X, and intends no further requirements for vessel reporting at this time. Conversely, review of reporting requirements for 505 Federally permitted lobster dealers indicates that of these, 356 Federal lobster dealers or approximately 70 percent, are currently obligated to report lobster sales by virtue of regulations for other Federally managed fisheries. Therefore, NMFS announces that it is considering and seeking public comment on implementation of Federal regulations that would extend full mandatory reporting coverage to the remaining 30 percent of Federal lobster dealer permit holders not already encompassed by existing Federal regulations.
        Of particular concern in the 2005 assessment report is the SNE stock, where depleted stock abundance and poor recruitment of juvenile lobsters, coupled with high fishing mortality rates, led the stock assessment and peer review panel to recommend additional harvest restrictions for SNE. The SNE stock extends from the waters south of Cape Cod, Massachusetts to the waters off North Carolina, and encompasses all of Lobster Conservation Management Areas (Area) 4, 5, and 6, and part of Area 2 and 3. According to the assessment, in SNE, 61-72 percent of the fishable stock is made up of new entrants into the legal fishery, and the 2005 stock assessment report noted concern that the fishery is too dependent on these new recruits. Based on recommendations in the 2005 assessment report, the Commission, in May 2007, approved Addendum XI that specifies additional lobster management measures for the SNE stock. Addendum XI also includes recommendations for complementary Federal action. Specific to this regulatory action, Addendum XI requires impacted states to implement a maximum legal carapace size limit of 5-1/4 inches (13.34 centimeters (cm)) in all SNE nearshore Areas (Area 2, 4, 5, and 6) by July 1, 2008, and implement a maximum legal carapace size limit of 7 inches (17.78 cm) in the offshore Area 3, and subsequently decreasing over a two year period to 6-3/4 inches (17.15 cm) by July 1, 2010. In addition to the maximum size limit, Addendum XI modifies the current V-notch definition in SNE. Current Federal regulations prohibit possession of a female lobster bearing a V-shaped notch on its tail. The current Federal standard V-notch definition in SNE is defined to be any female lobster that bears a straight sided triangular cut, without setal hairs, a least 1/4 inch (0.64 cm) deep, and tapering to a point. This standard V-notch definition is likely to protect notched lobsters until they molt or shed their exoskeleton for the first time after notching. Addendum XI modifies the V-notch definition to be any female lobster that bears a notch or indentation at least 1/8th inch (0.32 cm) deep, with or without setal hairs. This modified V-notch definition may protect notched lobsters for up to two molt cycles, a period that may span three or more years. This Notice announces and seeks public comment on NMFS' intention to implement a lobster maximum legal carapace size limits and modified V-notch definition compatible with those specified in Addendum XI.
        Classification
        This ANPR has been determined to be not significant for the purposes of Executive Order 12866.

          Authority:
          16 U.S.C. 5101 et seq.

          Dated: September 14, 2007.
          Samuel D. Rauch III,
          Deputy Assistant Administrator For Regulatory Programs, National Marine Fisheries Service.

      [FR Doc. E7-18589 Filed 9-20-07; 8:45 am]
      BILLING CODE 3510-22-S